Randomized Controlled Trial of an Educational Intervention for Managing Fatigue in Women Receiving Adjuvant Chemotherapy for Early-Stage Bre
http://www.100md.com
《临床肿瘤学》
the Centre for Health Research, Nursing, and Centre for Palliative Care Research and Education, Queensland University of Technology, Kelvin Grove
School of Population Health, University of Queensland, Brisbane
Haematology and Oncology Clinics of Australasia, Milton, Queensland
Peter MacCallum Cancer Institute
St Vincent's Hospital, Victoria Parade, Melbourne, Victoria, Australia
ABSTRACT
PURPOSE: To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.
PATIENTS AND METHODS: This randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.
RESULTS: Compared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.
CONCLUSION: Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.
INTRODUCTION
Fatigue is the most frequently reported side effect of cancer treatment, with a prevalence ranging from 25% to 99% at different times in treatment programs and across differing diagnostic groups.1 For some patients, cancer-related fatigue will persist for considerable periods of time at levels higher than those reported by healthy controls.2-4 Fatigue has also been identified as the most problematic side effect for women with breast cancer.5 Although the need for interventions to address the problem of cancer-related fatigue has been well documented,6,7 high-level evidence to guide fatigue management for people with cancer is limited.
Current clinical guidelines for reducing fatigue emphasize the importance of identifying the cause of the problem and correcting it.8 However, given the multidimensional nature of fatigue, it is also likely that a range of more general nonpharmacologic approaches will have potential as adjunctive measures in reducing the intensity and impact of this symptom.9 For example, there is an emerging evidence base to support the use of structured exercise programs for fatigue management in selected populations. A recent review of evidence for exercise as an intervention identified 20 experimental studies providing strong support for the positive effects of a range of activity- and exercise-based interventions for management of cancer-related fatigue.10 Other studies have reported that preparatory information for patients before undergoing treatments that induce fatigue can be beneficial11-13 and have suggested that it may be helpful just to acknowledge that fatigue is a symptom worthy of intervention simply by asking about it.14,15 A recent randomized controlled trial has also demonstrated that energy-conservation strategies, such as priority setting, delegation, and planning of activities, were effective in achieving a statistically significant improvement in fatigue levels for patients who received the intervention compared with patients who did not receive the intervention.16 Despite the central role that educative and supportive interventions have in a comprehensive fatigue-management plan, guidelines to assist health care professionals to incorporate these fundamental strategies into day to day practice are limited. The purpose of this study is to evaluate the efficacy of a brief targeted intervention that incorporates educative and supportive strategies to assist patients to develop knowledge and skills to engage in self-care behaviors that have the potential to minimize specific factors that may contribute to increased levels of fatigue, including decreased mobility or activity, ineffective use of available energy reserves, sleep disturbances, and anxiety or psychological concerns.17
PATIENTS AND METHODS
Study Design
A multicenter, randomized, controlled design with pre- and post-test follow-ups was used. Participants were outpatients with breast cancer who were receiving adjuvant treatment at five day-treatment units in three major metropolitan hospital settings.
During a 24-month data collection period from November 2000 to October 2002, all women more than 18 years of age with stage I or II breast cancer who were commencing adjuvant chemotherapy at any of the centers were approached at their first treatment visit for entry onto the study. Women were admitted to the study if they had an Eastern Cooperative Oncology Group performance rating of one or two and their hemoglobin level was at least 11.6 g/mL at recruitment. Baseline assessment was completed at the first treatment visit. The patient was then randomly assigned to intervention or control conditions through a central telephone system using computer-generated random numbers. Group allocation was concealed from research assistants involved in recruitment and the baseline and follow-up assessments.
A sample size of 35 patients per group was estimated as necessary to detect a significant difference in treatment effects on fatigue measures with 80% power and type I error of 5% (two sided). This allowed for the nondirectional detection of an effect size in line with the order of magnitude reported in a previous study18 and is close to an effect size conventionally defined by Cohen19 as large. To compensate for attrition and nonassessable patients, 110 patients were recruited to the study.
Figure 1 presents the time points for pre- and postintervention assessments for the study. All patients completed baseline assessments (T1) at the first treatment visit. Because patients receiving chemotherapy face a range of unfamiliar, highly stressful experiences, especially at their first treatment visit, the first control/intervention session was conducted at the second treatment visit to minimize the effect of high initial levels of anxiety on the patient's ability to participate in the intervention. Follow-up assessment was conducted on the day of each subsequent treatment cycle to minimize the confounding effects of treatment. As such, at T2 and T3, all assessments were conducted on the day of chemotherapy. For those patients who were commencing radiotherapy at T3 or T4, assessment was conducted on the first day of a course of radiotherapy. For those patients who were commencing radiotherapy at T3, T4 assessments were conducted 2 weeks after completion of radiotherapy.
Because there were similar numbers of patients who had received radiotherapy in both the intervention and control groups, any treatment-related differences between groups are expected to be similar. Secondary analyses were also conducted to identify any interaction effects resulting from these differing treatment programs.
Intervention
The psychoeducational intervention aimed to improve patients' knowledge and skills to enable them to perform self-care behaviors designed to minimize fatigue and was based on Green's PRECEDE (Predisposing, Reinforcing, and Enabling Causes in Educational Diagnosis and Evaluation) model of health behavior.20 This model identifies various factors that may potentially influence a health behavior, which, in this case, is the use of effective strategies to reduce fatigue, including self-care actions for promoting sleep and rest, promoting a balance between activity and exercise, conserving energy, and promoting restorative activities. The influencing factors targeted by the intervention included beliefs, attitudes, and perceptions that might facilitate or hinder a person's motivation to perform the desired behaviors; skills and resources necessary to perform the behaviors; and feedback provided by family or health professionals that might influence continuance or discontinuance of the behaviors. Thus, the intervention involved three individualized sessions tailored to the patient's specific needs and circumstances and was designed to target these influencing factors. It incorporated the techniques of information giving, problem solving, rehearsal, and reinforcement. The first session was, on average, 20 minutes in length and delivered face to face in the clinic at the patient's second course of chemotherapy.
The second and third sessions were conducted by phone 1 week apart and were, on average, 10 minutes in length. The initial session focused on identifying individual fatigue-management needs and the meaning and impact of fatigue on the patient's life. Protocols were developed to guide the specific questioning and the strategies used by nurses in response to individual fatigue-management needs. The protocols included both a guide to the overall structure and process of the intervention, as well as content to guide possible fatigue-management actions to be used for specific problems, including lack of knowledge about fatigue, reduced activity, sleep disturbance, anxiety, nutritional disturbance, and inadequate communication about fatigue. An extract from the intervention protocols, outlining the overall structure of the intervention, is presented in Table 1. To supplement the face-to-face interactions, written patient information was given in the form of a patient booklet developed from materials published by the Oncology Nursing Society.21 The patient booklet was also used to record additional individualized fatigue-management strategies. The two booster sessions were conducted at 1-week intervals by phone and were aimed at review of the patients' fatigue-management plan, identification of factors facilitating and hindering use of recommended fatigue-management actions, and reinforcement.
Control
Women allocated to the control group received general cancer education sessions equivalent in number and timing to the sessions that were provided for the intervention group. This involved an oncology nurse (not the intervention nurse) talking with the control group patients about general issues associated with living with cancer and providing them with a cancer information booklet containing general information about cancer published by the local cancer society. The control sessions were delivered in one face-to-face session, followed by two phone sessions at 1-week intervals. To facilitate standardization and quality control in delivery of interventions, a maximum of two oncology nurses were used at each site for administration of fatigue intervention sessions, and one oncology nurse was used at each site for delivering the control sessions. All nurses underwent a training program regarding the research program and the fatigue management or control intervention (whichever was relevant to their role). Nurses delivering the fatigue intervention were also provided with supplementary reading materials and standardized protocols to guide selection of fatigue-management strategies. Ongoing support was provided to both intervention and control nurses through regular discussion with the investigators, usually on a monthly basis.
Instruments
Data were collected using a structured questionnaire. Consistent with the model of health behavior of Green et al,20 the primary end points for the study included use of fatigue-management behaviors, confidence with managing fatigue, and fatigue intensity and impact. In addition, secondary outcomes relating to self-efficacy with coping with cancer, quality of life, and anxiety and depression were also assessed.
Fatigue-management behaviors. A list of 10 self-care actions patients may use to manage fatigue was developed from the literature. Patients were asked to indicate (yes or no) whether they had used these actions in the week before interview and whether health care professionals had recommended use of the actions during the past week. In addition, patients were asked to indicate whether they had spoken to a list of health care professionals about fatigue in the week before interview. On the basis of the responses to these items, use of fatigue behaviors in the week before interview was measured by creating three separate indices.
Confidence with managing fatigue. Patients were asked to rate how confident they felt managing fatigue on an 11-point numeric rating scale ranging from 0 (not at all confident) to 10 (very confident).
Fatigue experiences. Four 11-point numeric rating scales ranging from 0 (no fatigue) to 10 (fatigue as bad as you can imagine) were included to assess levels of fatigue at worst, best, and average in the past week and currently. In addition, 11-point numeric rating scales included in the Revised Piper Fatigue Scale22 were used to assess distress associated with fatigue (0 = no distress, 10 = a great deal of distress), severity of fatigue (0 = mild, 10 = severe), and the impact of fatigue (0 = none, 10 = a great deal) on four aspects of daily life during the past week. The Functional Assessment of Cancer Therapy–Fatigue was also used.23 This scale asks patients to rate the extent to which they had experienced each of 20 fatigue-related symptoms and experiences in the past 7 days using a numeric scale ranging from 0 (not at all) to 4 (very much).
Cancer self-efficacy, quality of life, and psychological well-being. Self-efficacy with coping with cancer was assessed using a 24-item instrument developed in earlier pilot studies (Campbell et al, unpublished report). The scale asks patients to indicate, on a scale ranging from 0 (not at all confident) to 10 (very confident), how certain they are that they can deal with a range of challenges experienced by patients with cancer, such as avoiding negative thoughts, keeping hopeful, and maintaining independence. In the present study, the cancer self-efficacy scale had a Cronbach's alpha of 0.97.
The 30-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (version 3) was used to measure health-related quality of life in cancer patients.24 Twenty-eight of the items within this scale are scored on a 4-point Likert scale, with the global health status and quality-of-life questions being scored on a 7-point scale. The 14-item Hospital Anxiety and Depression Scale25 was used to assess anxiety and depression.
Demographic and medical information. Details of patient demographics, current illness, and treatment plan were obtained from the patient's oncologist and medical records using a standard data collection form.
Analysis
Data were entered and analyzed using SPSS version 11.5 (SPSS Inc, Chicago, IL). Initially, control and intervention groups were compared at baseline with respect to demographic and medical variables to ensure comparability of groups. Scale scores were then constructed for each of the outcome variables, and reliability estimates were calculated for each scale. In fatigue scales, a score of 0 was given to patients reporting no fatigue.
Group differences were determined by t tests for the continuous, normally distributed data and by 2 tests for categoric data. Descriptive statistics were calculated for the intervention and control groups for each of the four time points to observe trends in these outcome measures over time. Finally, to test each hypothesis, analysis of covariance of the change scores was conducted, controlling for the corresponding baseline value of the variable to adjust for any group differences at baseline. At the third follow-up, some patients had received radiotherapy treatment. Consequently, analysis of change scores between T4 and baseline also included a term for the interaction between treatment group allocation and whether patients had received radiotherapy treatment before T4 assessment. These analyses did not demonstrate any significant differences in effects for any of the outcome variables.
RESULTS
Figure 2 presents the flow of participants through the study. Of the 110 eligible patients who were randomly assigned to the treatment and control groups, one patient did not meet eligibility criteria and, thus, was excluded. Of the 109 patients who completed at least one intervention session, 104 patients completed T2 assessment (1 to 2 weeks after completion of the intervention), 100 patients completed T3 assessment (3 to 4 weeks after T2), and 97 patients completed T4 assessment (3 to 4 weeks after T3 if chemotherapy was continuing or 6 to 8 weeks after T3 if a 4- to 6-week course of radiotherapy had been received since T3).
The demographics of the sample are listed in Table 2. The age of participants ranged from 26 to 70 years, with a mean age of 49.4 years (standard deviation = 9.4 years). Many of the women were from relatively high socioeconomic backgrounds, with the median annual family income group being $40,001 to $50,000 Australian dollars, and approximately 65% of the sample had post–high school qualifications. Most of the women in the study were married. The only significant demographic difference between the intervention and control groups was that the control group had a higher proportion of participants born overseas. Given the small numbers in this group, this difference was not adjusted for in subsequent analyses.
To be eligible for the study, all women had to have a diagnosis of early-stage breast cancer and be scheduled to commence a standard course of adjuvant chemotherapy. Table 3 lists the diagnostic and treatment characteristics for the 109 study participants. There were no significant differences between the intervention and control groups at baseline for these medical variables, including whether or not women received a course of radiotherapy during the study period.
Fatigue-Management Behaviors
Patients indicated their use (yes or no) of 10 specified actions taken to manage fatigue. Overall, the most commonly used actions reported at baseline were rest (67%), hydration (50%), relaxation (48%), exercise (40%), and listening to music (39%). Use of these actions remained relatively stable over time, and there were no significant differences in usage between groups.
Fatigue behavior scores were calculated for each patient to tally the following for the previous week: the number of fatigue-management actions used (scores ranging from 0 = none to 10 = all listed); (2) the number of health care professionals with whom the patient had discussed fatigue (scores ranging from 0 = none to 6 = all listed); and (3) the number of fatigue-management actions that had been recommended (scores ranging from 0 = none to 10 = all listed). The distributions of scores on these indices are listed in Table 4. Overall, the mean number of health care professionals spoken to and the mean number of actions taken to manage fatigue were low for both groups.
Results in Table 4 report no significant differences between groups in change scores for communication with health professionals about fatigue or number of actions taken to manage fatigue. However, patients in the intervention group reported a significantly greater mean increase in the number of actions recommended compared with patients in the control group between the T1 and T2 and T1 and T4 assessments.
Confidence With Managing Fatigue
The results indicate no significant differences between control and intervention groups in baseline to postintervention change scores for confidence with managing fatigue.
Fatigue Experiences
Descriptive analyses indicate notable increases in mean fatigue levels for both groups on all fatigue measures between T1 and T2, with these higher levels of fatigue persisting at T3 and decreasing only slightly by T4. The results listed in Table 5 indicate that the increases between the baseline and immediate postintervention fatigue scores were significantly greater for the control group when compared with the intervention group for fatigue at worst, average fatigue, fatigue severity, fatigue interference, and Functional Assessment of Cancer Therapy. This increase was consistently more than 50% greater for the control group when compared with the intervention group. However, these differences were not sustained for changes between baseline and T3 or T4.
Secondary Outcomes
There was no significant effect of the intervention for cancer self-efficacy, quality of life, or psychological well-being.
DISCUSSION
The aim of this study was to evaluate the efficacy of a brief psychoeducational intervention in improving the use of fatigue-management behaviors and minimizing the impact of fatigue for women receiving treatment for early-stage breast cancer. Importantly, our findings suggest that women who received the intervention received some short-term benefit in terms of minimization of the intensity and impact of fatigue on daily life. Specifically, the study has found that women in the control group consistently experienced an increase in levels of fatigue and interference from fatigue over the treatment course that was consistently more than 50% greater than that reported by women in the intervention group. Moreover, patients in the intervention group reported a significantly greater mean increase in the number of fatigue-management actions recommended by health care professionals compared with patients in the control group between the T1 and T2 and T1 and T4 assessments. As a manipulation check, this finding may suggest that the intervention was achieving its desired goal in terms of increasing patient awareness of potential fatigue-management actions. Such evidence supports previous research demonstrating the positive benefits of intervention strategies, such as energy conservation and exercise,10,16 and suggests that this brief educative and supportive intervention has some potential in reducing cancer-related fatigue. However, the failure to observe significant postintervention differences for other key outcomes and the failure to observe sustainable improvements in fatigue reduction raises important clinical questions about the potential efficacy of educative and supportive interventions for complex, multifactorial problems such as fatigue. A number of possible limitations of this study, including the effect of some potential confounding variables and measurement error, also need to be considered.
First, it should be noted that the significant effects observed in this study reflect improvements on the subjective measures of fatigue experiences, rather than for objective measures of fatigue-management behavior such as the number of fatigue-management actions used. As such, one possible explanation for the findings is that the differences observed may simply reflect patient expectations that they would benefit from the intervention or their desire to respond positively to the researchers. To minimize the effects of such confounding factors, this study included an attentional control group who received a generalized supportive intervention of equivalent timing to the intervention group, and nurses who undertook baseline and follow-up assessments were blind to which group patients had been allocated. Despite these measures, the use of self-report as the sole method for measuring fatigue-management actions makes it difficult to determine the extent to which any such placebo effects may be operating. A recent review of studies investigating placebo effects attributable to the patient-practitioner relationship concluded that patients' expectancies are associated with improved outcomes in many trials, but that, because several of the trials reviewed were not randomized and the majority reported subjective outcomes, definitive conclusions could not be made.26
Moreover, other researchers have noted that criteria for determining the amount of improvement needed for a symptomatic response to be considered meaningful are not readily available.27 As such, even though the effect size observed in the present study was large and across measures of interference as well as severity, we cannot rule out the possibility that at least some of the observed effect is attributable to patient expectancies. Notwithstanding the methodologic issues raised by these possibilities, the findings of this study nevertheless underscore the critical importance of the practitioner-patient relationship to intervention outcomes. The need to understand precisely what is occurring in interactions to achieve an observed change is an important area of inquiry that has profound implications for education, research, and practice.
A second explanation for the study findings is that educative and supportive interventions are simply not powerful enough to detect sustainable improvements, especially in studies where the sample under investigation is likely to experience significant variation in levels of fatigue. Furthermore, it is possible that the particular intervention evaluated in the present study is not sufficiently potent to achieve the degree of behavior change required for complex multifactorial symptoms such as fatigue. Potency in this context might relate to issues such as the intensity, specificity, and sensitivity of the intervention in achieving the desired outcomes.28 More specifically, issues such as accuracy and quality in delivering interventions, the appropriateness of the strategies used for the problem, and the dose or intensity of the intervention need to be considered. In the present study, efforts were made to ensure the accuracy and quality of the intervention by training the intervention nurses, by regular informal discussions with intervention nurses, and by developing evidence-based protocols to provide decisional support tools for these nurses. However, even with these measures, it is possible that the skills required for delivering targeted and tailored interventions to address the complex multifaceted problem of fatigue are quite advanced and that further ongoing support and training may be required. For example, additional strategies, such as tape recording of intervention sessions for peer review, may be useful to facilitate quality control and gain an understanding of intervention processes.
The development of high-quality decision support tools, based on an in-depth understanding of the problem, evidence about the nature of processes through which the intervention resolves the problem or provides the desired outcome, and the specific activities constituting the intervention, is also recommended.28 For example, an understanding of typical patterns of fatigue across the course of treatment may suggest that timing of this type of intervention may be one factor influencing its effectiveness. In the present study, the intervention was delivered early in the treatment course and was completed before the third cycle of chemotherapy.
However, our data illustrate that the intensity of fatigue was far greater later in the course of treatment. As such, although the intervention studied in the present trial may be considered useful from a preparatory perspective, it is possible that further benefits may have been realized if it was delivered later in the treatment course when the problem of fatigue may be more of a priority for patients. Further booster sessions may also be necessary to complement a preparatory intervention of this type.
The timing for delivery of follow-up assessments may also have impacted on the study findings. In the present study, follow-up assessments were conducted on the last day of a 21- or 28-day treatment cycle or 2 weeks after completion of radiotherapy, when peak effects of chemotherapy may have subsided. It may be that the benefit of the intervention occurs when fatigue levels are at their peak, usually in the week after chemotherapy administration, and as a result, the effect of the intervention strategies in this study was not detected at the time of follow-up assessment when fatigue levels may have been less intense. In a similar vein, the dose of the intervention used in the present study requires some consideration. Studies examining the dose-response relationship in psychotherapeutic interventions29 have reported a positive relationship between the amount of psychotherapy and level of patient benefit, with 10% to 18% of patients showing some improvement before the first session, 18% to 48% improving by the eighth session, and 75% improving by 6 months. However, a more recent systematic review of patient education interventions in cancer found that published studies reported, on average, three contacts per patient, but the length of these contacts was not described in detail, and no difference in outcomes was observed according to whether short versus longer information packages were provided to patients.30 The dose dimension of an intervention is rarely discussed in patient education research despite the critical importance of this dimension to the translation of findings into practice.
Finally, it is also important to consider whether the nonsignificant effects observed for the study's key behavioral outcomes are a result of measurement error. In the present study, an index of fatigue behaviors was developed from a review of the literature, whereby patients indicated by responding yes or no to whether they had used a list of 10 behaviors. However, the behaviors selected and the dichotomous measurement scale used may not be valid or sensitive enough to detect actual differences in fatigue self-management behaviors. Although a number of valid and reliable measures of health-related attitudes, quality of life, and other subjective experiences are available to evaluate outcomes from educational intervention, psychometrically sound measures of behavioral outcomes are not as readily available.
This study addresses the problem of fatigue, which is recognized as one of the most common and distressing symptoms experienced by people undergoing cancer treatment. Although the limitations of this study need to be acknowledged, the study represents one of the few controlled trials of educative and supportive interventions designed to build this evidence base. The findings provide some evidence of the potential benefits of educative and supportive intervention in ameliorating fatigue for women receiving treatment for early-stage breast cancer. However, because the findings indicate that the effectiveness of the intervention across all outcomes is not consistent and is only short term, further work is needed to test whether such interventions are beneficial for patients experiencing different levels of fatigue and to improve the sustainability and potency of interventions of this type. Further research that focuses on identifying the specific strategies that achieve behavioral change and the context in which such intervention strategies are best used is required.
Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
NOTES
Supported by grants received from the Queensland Nursing Council and the National Breast Cancer Foundation, Australia.
The views expressed in this article do not necessarily represent the views of the Queensland Nursing Council or the members, executive officer, or staff of the Council.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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Servaes P, Verhagen C, Bleijenberg G: Fatigue in cancer patients and after treatment: Prevalence, correlates and interventions. Eur J Cancer 38:27-43, 2002
Broeckel JA, Jacobsen PB, Horton J, et al: Characteristics and correlates of fatigue after adjuvant chemotherapy for breast cancer. J Clin Oncol 16:1689-1696, 1998
Loge J, Abrahamsen A, Ekeberg C, et al: Fatigue and psychiatric morbidity among Hodgkin's disease survivors. J Pain Symptom Manage 19:91-99, 2000
Servaes P, van-der-Werf S, Prins J, et al: Fatigue in disease-free cancer patients compared with fatigue in patients with chronic fatigue syndrome. Support Care Cancer 9:11-17, 2001
Longman AJ, Braden CJ, Mishel MH: Side-effects burden, psychological adjustment, and life quality in women with breast cancer: Pattern of association over time. Oncol Nurs Forum 26:909-915, 1999
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Jacobsen P, Hann D: Fatigue in women receiving adjuvant chemotherapy for breast cancer: Characteristics, course and correlates. J Pain Symptom Manage 18:233-242, 1999
Cancer-Related Fatigue and Anemia—Treatment guidelines for Patients, Version II. National Comprehensive Cancer Network, April 2003
Ahlberg K, Ekman T, Gaston-Johansson F, et al: Assessment and management of cancer-related fatigue in adults. Lancet 362:640-650, 2003
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Passik S, Kirsh K, Donaghy K, et al: Patient related barriers to fatigue communication: Initial validation of the Fatigue Management Barriers Questionnaire. J Pain Symptom Manage 24:481-493, 2002
Barsevick AM, Dudley W, Beck S, et al: A randomized clinical trial of energy conservation for patients with cancer-related fatigue. Cancer 100:1302-1310, 2004
Portenoy R, Itri L: Cancer-related fatigue: Guidelines for evaluation and management. Oncologist 4:1-10, 1999
Mock V, Hassey Dow K, Meares CJ, et al: Effects of exercise on fatigue, physical function and emotional distress during radiation therapy for breast cancer. Oncol Nurs Forum 24:991-1000, 1997
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Green LW, Kreuter MW, Deeds SG, et al: Health Education Planning: A Diagnostic Approach. Mountain View, CA, Mayfield Publishing Company, 1980, pp 10-17
Oncology Nursing Society: Get Energized: Conquer Fatigue! Pittsburgh, PA, Oncology Nursing Society, 2000
Piper BF, Dibble SL, Dodd MJ, et al: The Revised Piper Fatigue Scale: Psychometric evaluation in women with breast cancer. Oncol Nurs Forum 25:677-684, 1998
Yellen SB, Cella D, Webster K, et al: Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) Measurement System. J Pain Symptom Manage 13:63-74, 1997
Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organisation for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993
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School of Population Health, University of Queensland, Brisbane
Haematology and Oncology Clinics of Australasia, Milton, Queensland
Peter MacCallum Cancer Institute
St Vincent's Hospital, Victoria Parade, Melbourne, Victoria, Australia
ABSTRACT
PURPOSE: To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.
PATIENTS AND METHODS: This randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.
RESULTS: Compared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.
CONCLUSION: Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.
INTRODUCTION
Fatigue is the most frequently reported side effect of cancer treatment, with a prevalence ranging from 25% to 99% at different times in treatment programs and across differing diagnostic groups.1 For some patients, cancer-related fatigue will persist for considerable periods of time at levels higher than those reported by healthy controls.2-4 Fatigue has also been identified as the most problematic side effect for women with breast cancer.5 Although the need for interventions to address the problem of cancer-related fatigue has been well documented,6,7 high-level evidence to guide fatigue management for people with cancer is limited.
Current clinical guidelines for reducing fatigue emphasize the importance of identifying the cause of the problem and correcting it.8 However, given the multidimensional nature of fatigue, it is also likely that a range of more general nonpharmacologic approaches will have potential as adjunctive measures in reducing the intensity and impact of this symptom.9 For example, there is an emerging evidence base to support the use of structured exercise programs for fatigue management in selected populations. A recent review of evidence for exercise as an intervention identified 20 experimental studies providing strong support for the positive effects of a range of activity- and exercise-based interventions for management of cancer-related fatigue.10 Other studies have reported that preparatory information for patients before undergoing treatments that induce fatigue can be beneficial11-13 and have suggested that it may be helpful just to acknowledge that fatigue is a symptom worthy of intervention simply by asking about it.14,15 A recent randomized controlled trial has also demonstrated that energy-conservation strategies, such as priority setting, delegation, and planning of activities, were effective in achieving a statistically significant improvement in fatigue levels for patients who received the intervention compared with patients who did not receive the intervention.16 Despite the central role that educative and supportive interventions have in a comprehensive fatigue-management plan, guidelines to assist health care professionals to incorporate these fundamental strategies into day to day practice are limited. The purpose of this study is to evaluate the efficacy of a brief targeted intervention that incorporates educative and supportive strategies to assist patients to develop knowledge and skills to engage in self-care behaviors that have the potential to minimize specific factors that may contribute to increased levels of fatigue, including decreased mobility or activity, ineffective use of available energy reserves, sleep disturbances, and anxiety or psychological concerns.17
PATIENTS AND METHODS
Study Design
A multicenter, randomized, controlled design with pre- and post-test follow-ups was used. Participants were outpatients with breast cancer who were receiving adjuvant treatment at five day-treatment units in three major metropolitan hospital settings.
During a 24-month data collection period from November 2000 to October 2002, all women more than 18 years of age with stage I or II breast cancer who were commencing adjuvant chemotherapy at any of the centers were approached at their first treatment visit for entry onto the study. Women were admitted to the study if they had an Eastern Cooperative Oncology Group performance rating of one or two and their hemoglobin level was at least 11.6 g/mL at recruitment. Baseline assessment was completed at the first treatment visit. The patient was then randomly assigned to intervention or control conditions through a central telephone system using computer-generated random numbers. Group allocation was concealed from research assistants involved in recruitment and the baseline and follow-up assessments.
A sample size of 35 patients per group was estimated as necessary to detect a significant difference in treatment effects on fatigue measures with 80% power and type I error of 5% (two sided). This allowed for the nondirectional detection of an effect size in line with the order of magnitude reported in a previous study18 and is close to an effect size conventionally defined by Cohen19 as large. To compensate for attrition and nonassessable patients, 110 patients were recruited to the study.
Figure 1 presents the time points for pre- and postintervention assessments for the study. All patients completed baseline assessments (T1) at the first treatment visit. Because patients receiving chemotherapy face a range of unfamiliar, highly stressful experiences, especially at their first treatment visit, the first control/intervention session was conducted at the second treatment visit to minimize the effect of high initial levels of anxiety on the patient's ability to participate in the intervention. Follow-up assessment was conducted on the day of each subsequent treatment cycle to minimize the confounding effects of treatment. As such, at T2 and T3, all assessments were conducted on the day of chemotherapy. For those patients who were commencing radiotherapy at T3 or T4, assessment was conducted on the first day of a course of radiotherapy. For those patients who were commencing radiotherapy at T3, T4 assessments were conducted 2 weeks after completion of radiotherapy.
Because there were similar numbers of patients who had received radiotherapy in both the intervention and control groups, any treatment-related differences between groups are expected to be similar. Secondary analyses were also conducted to identify any interaction effects resulting from these differing treatment programs.
Intervention
The psychoeducational intervention aimed to improve patients' knowledge and skills to enable them to perform self-care behaviors designed to minimize fatigue and was based on Green's PRECEDE (Predisposing, Reinforcing, and Enabling Causes in Educational Diagnosis and Evaluation) model of health behavior.20 This model identifies various factors that may potentially influence a health behavior, which, in this case, is the use of effective strategies to reduce fatigue, including self-care actions for promoting sleep and rest, promoting a balance between activity and exercise, conserving energy, and promoting restorative activities. The influencing factors targeted by the intervention included beliefs, attitudes, and perceptions that might facilitate or hinder a person's motivation to perform the desired behaviors; skills and resources necessary to perform the behaviors; and feedback provided by family or health professionals that might influence continuance or discontinuance of the behaviors. Thus, the intervention involved three individualized sessions tailored to the patient's specific needs and circumstances and was designed to target these influencing factors. It incorporated the techniques of information giving, problem solving, rehearsal, and reinforcement. The first session was, on average, 20 minutes in length and delivered face to face in the clinic at the patient's second course of chemotherapy.
The second and third sessions were conducted by phone 1 week apart and were, on average, 10 minutes in length. The initial session focused on identifying individual fatigue-management needs and the meaning and impact of fatigue on the patient's life. Protocols were developed to guide the specific questioning and the strategies used by nurses in response to individual fatigue-management needs. The protocols included both a guide to the overall structure and process of the intervention, as well as content to guide possible fatigue-management actions to be used for specific problems, including lack of knowledge about fatigue, reduced activity, sleep disturbance, anxiety, nutritional disturbance, and inadequate communication about fatigue. An extract from the intervention protocols, outlining the overall structure of the intervention, is presented in Table 1. To supplement the face-to-face interactions, written patient information was given in the form of a patient booklet developed from materials published by the Oncology Nursing Society.21 The patient booklet was also used to record additional individualized fatigue-management strategies. The two booster sessions were conducted at 1-week intervals by phone and were aimed at review of the patients' fatigue-management plan, identification of factors facilitating and hindering use of recommended fatigue-management actions, and reinforcement.
Control
Women allocated to the control group received general cancer education sessions equivalent in number and timing to the sessions that were provided for the intervention group. This involved an oncology nurse (not the intervention nurse) talking with the control group patients about general issues associated with living with cancer and providing them with a cancer information booklet containing general information about cancer published by the local cancer society. The control sessions were delivered in one face-to-face session, followed by two phone sessions at 1-week intervals. To facilitate standardization and quality control in delivery of interventions, a maximum of two oncology nurses were used at each site for administration of fatigue intervention sessions, and one oncology nurse was used at each site for delivering the control sessions. All nurses underwent a training program regarding the research program and the fatigue management or control intervention (whichever was relevant to their role). Nurses delivering the fatigue intervention were also provided with supplementary reading materials and standardized protocols to guide selection of fatigue-management strategies. Ongoing support was provided to both intervention and control nurses through regular discussion with the investigators, usually on a monthly basis.
Instruments
Data were collected using a structured questionnaire. Consistent with the model of health behavior of Green et al,20 the primary end points for the study included use of fatigue-management behaviors, confidence with managing fatigue, and fatigue intensity and impact. In addition, secondary outcomes relating to self-efficacy with coping with cancer, quality of life, and anxiety and depression were also assessed.
Fatigue-management behaviors. A list of 10 self-care actions patients may use to manage fatigue was developed from the literature. Patients were asked to indicate (yes or no) whether they had used these actions in the week before interview and whether health care professionals had recommended use of the actions during the past week. In addition, patients were asked to indicate whether they had spoken to a list of health care professionals about fatigue in the week before interview. On the basis of the responses to these items, use of fatigue behaviors in the week before interview was measured by creating three separate indices.
Confidence with managing fatigue. Patients were asked to rate how confident they felt managing fatigue on an 11-point numeric rating scale ranging from 0 (not at all confident) to 10 (very confident).
Fatigue experiences. Four 11-point numeric rating scales ranging from 0 (no fatigue) to 10 (fatigue as bad as you can imagine) were included to assess levels of fatigue at worst, best, and average in the past week and currently. In addition, 11-point numeric rating scales included in the Revised Piper Fatigue Scale22 were used to assess distress associated with fatigue (0 = no distress, 10 = a great deal of distress), severity of fatigue (0 = mild, 10 = severe), and the impact of fatigue (0 = none, 10 = a great deal) on four aspects of daily life during the past week. The Functional Assessment of Cancer Therapy–Fatigue was also used.23 This scale asks patients to rate the extent to which they had experienced each of 20 fatigue-related symptoms and experiences in the past 7 days using a numeric scale ranging from 0 (not at all) to 4 (very much).
Cancer self-efficacy, quality of life, and psychological well-being. Self-efficacy with coping with cancer was assessed using a 24-item instrument developed in earlier pilot studies (Campbell et al, unpublished report). The scale asks patients to indicate, on a scale ranging from 0 (not at all confident) to 10 (very confident), how certain they are that they can deal with a range of challenges experienced by patients with cancer, such as avoiding negative thoughts, keeping hopeful, and maintaining independence. In the present study, the cancer self-efficacy scale had a Cronbach's alpha of 0.97.
The 30-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (version 3) was used to measure health-related quality of life in cancer patients.24 Twenty-eight of the items within this scale are scored on a 4-point Likert scale, with the global health status and quality-of-life questions being scored on a 7-point scale. The 14-item Hospital Anxiety and Depression Scale25 was used to assess anxiety and depression.
Demographic and medical information. Details of patient demographics, current illness, and treatment plan were obtained from the patient's oncologist and medical records using a standard data collection form.
Analysis
Data were entered and analyzed using SPSS version 11.5 (SPSS Inc, Chicago, IL). Initially, control and intervention groups were compared at baseline with respect to demographic and medical variables to ensure comparability of groups. Scale scores were then constructed for each of the outcome variables, and reliability estimates were calculated for each scale. In fatigue scales, a score of 0 was given to patients reporting no fatigue.
Group differences were determined by t tests for the continuous, normally distributed data and by 2 tests for categoric data. Descriptive statistics were calculated for the intervention and control groups for each of the four time points to observe trends in these outcome measures over time. Finally, to test each hypothesis, analysis of covariance of the change scores was conducted, controlling for the corresponding baseline value of the variable to adjust for any group differences at baseline. At the third follow-up, some patients had received radiotherapy treatment. Consequently, analysis of change scores between T4 and baseline also included a term for the interaction between treatment group allocation and whether patients had received radiotherapy treatment before T4 assessment. These analyses did not demonstrate any significant differences in effects for any of the outcome variables.
RESULTS
Figure 2 presents the flow of participants through the study. Of the 110 eligible patients who were randomly assigned to the treatment and control groups, one patient did not meet eligibility criteria and, thus, was excluded. Of the 109 patients who completed at least one intervention session, 104 patients completed T2 assessment (1 to 2 weeks after completion of the intervention), 100 patients completed T3 assessment (3 to 4 weeks after T2), and 97 patients completed T4 assessment (3 to 4 weeks after T3 if chemotherapy was continuing or 6 to 8 weeks after T3 if a 4- to 6-week course of radiotherapy had been received since T3).
The demographics of the sample are listed in Table 2. The age of participants ranged from 26 to 70 years, with a mean age of 49.4 years (standard deviation = 9.4 years). Many of the women were from relatively high socioeconomic backgrounds, with the median annual family income group being $40,001 to $50,000 Australian dollars, and approximately 65% of the sample had post–high school qualifications. Most of the women in the study were married. The only significant demographic difference between the intervention and control groups was that the control group had a higher proportion of participants born overseas. Given the small numbers in this group, this difference was not adjusted for in subsequent analyses.
To be eligible for the study, all women had to have a diagnosis of early-stage breast cancer and be scheduled to commence a standard course of adjuvant chemotherapy. Table 3 lists the diagnostic and treatment characteristics for the 109 study participants. There were no significant differences between the intervention and control groups at baseline for these medical variables, including whether or not women received a course of radiotherapy during the study period.
Fatigue-Management Behaviors
Patients indicated their use (yes or no) of 10 specified actions taken to manage fatigue. Overall, the most commonly used actions reported at baseline were rest (67%), hydration (50%), relaxation (48%), exercise (40%), and listening to music (39%). Use of these actions remained relatively stable over time, and there were no significant differences in usage between groups.
Fatigue behavior scores were calculated for each patient to tally the following for the previous week: the number of fatigue-management actions used (scores ranging from 0 = none to 10 = all listed); (2) the number of health care professionals with whom the patient had discussed fatigue (scores ranging from 0 = none to 6 = all listed); and (3) the number of fatigue-management actions that had been recommended (scores ranging from 0 = none to 10 = all listed). The distributions of scores on these indices are listed in Table 4. Overall, the mean number of health care professionals spoken to and the mean number of actions taken to manage fatigue were low for both groups.
Results in Table 4 report no significant differences between groups in change scores for communication with health professionals about fatigue or number of actions taken to manage fatigue. However, patients in the intervention group reported a significantly greater mean increase in the number of actions recommended compared with patients in the control group between the T1 and T2 and T1 and T4 assessments.
Confidence With Managing Fatigue
The results indicate no significant differences between control and intervention groups in baseline to postintervention change scores for confidence with managing fatigue.
Fatigue Experiences
Descriptive analyses indicate notable increases in mean fatigue levels for both groups on all fatigue measures between T1 and T2, with these higher levels of fatigue persisting at T3 and decreasing only slightly by T4. The results listed in Table 5 indicate that the increases between the baseline and immediate postintervention fatigue scores were significantly greater for the control group when compared with the intervention group for fatigue at worst, average fatigue, fatigue severity, fatigue interference, and Functional Assessment of Cancer Therapy. This increase was consistently more than 50% greater for the control group when compared with the intervention group. However, these differences were not sustained for changes between baseline and T3 or T4.
Secondary Outcomes
There was no significant effect of the intervention for cancer self-efficacy, quality of life, or psychological well-being.
DISCUSSION
The aim of this study was to evaluate the efficacy of a brief psychoeducational intervention in improving the use of fatigue-management behaviors and minimizing the impact of fatigue for women receiving treatment for early-stage breast cancer. Importantly, our findings suggest that women who received the intervention received some short-term benefit in terms of minimization of the intensity and impact of fatigue on daily life. Specifically, the study has found that women in the control group consistently experienced an increase in levels of fatigue and interference from fatigue over the treatment course that was consistently more than 50% greater than that reported by women in the intervention group. Moreover, patients in the intervention group reported a significantly greater mean increase in the number of fatigue-management actions recommended by health care professionals compared with patients in the control group between the T1 and T2 and T1 and T4 assessments. As a manipulation check, this finding may suggest that the intervention was achieving its desired goal in terms of increasing patient awareness of potential fatigue-management actions. Such evidence supports previous research demonstrating the positive benefits of intervention strategies, such as energy conservation and exercise,10,16 and suggests that this brief educative and supportive intervention has some potential in reducing cancer-related fatigue. However, the failure to observe significant postintervention differences for other key outcomes and the failure to observe sustainable improvements in fatigue reduction raises important clinical questions about the potential efficacy of educative and supportive interventions for complex, multifactorial problems such as fatigue. A number of possible limitations of this study, including the effect of some potential confounding variables and measurement error, also need to be considered.
First, it should be noted that the significant effects observed in this study reflect improvements on the subjective measures of fatigue experiences, rather than for objective measures of fatigue-management behavior such as the number of fatigue-management actions used. As such, one possible explanation for the findings is that the differences observed may simply reflect patient expectations that they would benefit from the intervention or their desire to respond positively to the researchers. To minimize the effects of such confounding factors, this study included an attentional control group who received a generalized supportive intervention of equivalent timing to the intervention group, and nurses who undertook baseline and follow-up assessments were blind to which group patients had been allocated. Despite these measures, the use of self-report as the sole method for measuring fatigue-management actions makes it difficult to determine the extent to which any such placebo effects may be operating. A recent review of studies investigating placebo effects attributable to the patient-practitioner relationship concluded that patients' expectancies are associated with improved outcomes in many trials, but that, because several of the trials reviewed were not randomized and the majority reported subjective outcomes, definitive conclusions could not be made.26
Moreover, other researchers have noted that criteria for determining the amount of improvement needed for a symptomatic response to be considered meaningful are not readily available.27 As such, even though the effect size observed in the present study was large and across measures of interference as well as severity, we cannot rule out the possibility that at least some of the observed effect is attributable to patient expectancies. Notwithstanding the methodologic issues raised by these possibilities, the findings of this study nevertheless underscore the critical importance of the practitioner-patient relationship to intervention outcomes. The need to understand precisely what is occurring in interactions to achieve an observed change is an important area of inquiry that has profound implications for education, research, and practice.
A second explanation for the study findings is that educative and supportive interventions are simply not powerful enough to detect sustainable improvements, especially in studies where the sample under investigation is likely to experience significant variation in levels of fatigue. Furthermore, it is possible that the particular intervention evaluated in the present study is not sufficiently potent to achieve the degree of behavior change required for complex multifactorial symptoms such as fatigue. Potency in this context might relate to issues such as the intensity, specificity, and sensitivity of the intervention in achieving the desired outcomes.28 More specifically, issues such as accuracy and quality in delivering interventions, the appropriateness of the strategies used for the problem, and the dose or intensity of the intervention need to be considered. In the present study, efforts were made to ensure the accuracy and quality of the intervention by training the intervention nurses, by regular informal discussions with intervention nurses, and by developing evidence-based protocols to provide decisional support tools for these nurses. However, even with these measures, it is possible that the skills required for delivering targeted and tailored interventions to address the complex multifaceted problem of fatigue are quite advanced and that further ongoing support and training may be required. For example, additional strategies, such as tape recording of intervention sessions for peer review, may be useful to facilitate quality control and gain an understanding of intervention processes.
The development of high-quality decision support tools, based on an in-depth understanding of the problem, evidence about the nature of processes through which the intervention resolves the problem or provides the desired outcome, and the specific activities constituting the intervention, is also recommended.28 For example, an understanding of typical patterns of fatigue across the course of treatment may suggest that timing of this type of intervention may be one factor influencing its effectiveness. In the present study, the intervention was delivered early in the treatment course and was completed before the third cycle of chemotherapy.
However, our data illustrate that the intensity of fatigue was far greater later in the course of treatment. As such, although the intervention studied in the present trial may be considered useful from a preparatory perspective, it is possible that further benefits may have been realized if it was delivered later in the treatment course when the problem of fatigue may be more of a priority for patients. Further booster sessions may also be necessary to complement a preparatory intervention of this type.
The timing for delivery of follow-up assessments may also have impacted on the study findings. In the present study, follow-up assessments were conducted on the last day of a 21- or 28-day treatment cycle or 2 weeks after completion of radiotherapy, when peak effects of chemotherapy may have subsided. It may be that the benefit of the intervention occurs when fatigue levels are at their peak, usually in the week after chemotherapy administration, and as a result, the effect of the intervention strategies in this study was not detected at the time of follow-up assessment when fatigue levels may have been less intense. In a similar vein, the dose of the intervention used in the present study requires some consideration. Studies examining the dose-response relationship in psychotherapeutic interventions29 have reported a positive relationship between the amount of psychotherapy and level of patient benefit, with 10% to 18% of patients showing some improvement before the first session, 18% to 48% improving by the eighth session, and 75% improving by 6 months. However, a more recent systematic review of patient education interventions in cancer found that published studies reported, on average, three contacts per patient, but the length of these contacts was not described in detail, and no difference in outcomes was observed according to whether short versus longer information packages were provided to patients.30 The dose dimension of an intervention is rarely discussed in patient education research despite the critical importance of this dimension to the translation of findings into practice.
Finally, it is also important to consider whether the nonsignificant effects observed for the study's key behavioral outcomes are a result of measurement error. In the present study, an index of fatigue behaviors was developed from a review of the literature, whereby patients indicated by responding yes or no to whether they had used a list of 10 behaviors. However, the behaviors selected and the dichotomous measurement scale used may not be valid or sensitive enough to detect actual differences in fatigue self-management behaviors. Although a number of valid and reliable measures of health-related attitudes, quality of life, and other subjective experiences are available to evaluate outcomes from educational intervention, psychometrically sound measures of behavioral outcomes are not as readily available.
This study addresses the problem of fatigue, which is recognized as one of the most common and distressing symptoms experienced by people undergoing cancer treatment. Although the limitations of this study need to be acknowledged, the study represents one of the few controlled trials of educative and supportive interventions designed to build this evidence base. The findings provide some evidence of the potential benefits of educative and supportive intervention in ameliorating fatigue for women receiving treatment for early-stage breast cancer. However, because the findings indicate that the effectiveness of the intervention across all outcomes is not consistent and is only short term, further work is needed to test whether such interventions are beneficial for patients experiencing different levels of fatigue and to improve the sustainability and potency of interventions of this type. Further research that focuses on identifying the specific strategies that achieve behavioral change and the context in which such intervention strategies are best used is required.
Authors' Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
NOTES
Supported by grants received from the Queensland Nursing Council and the National Breast Cancer Foundation, Australia.
The views expressed in this article do not necessarily represent the views of the Queensland Nursing Council or the members, executive officer, or staff of the Council.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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