<b>PURPOSE: </b>Fatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly coexists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a four-arm randomized controlled trial (RCT) study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors.<b>Patients and METHODS: </b>This study was a four-arm factorial study with CBTI-I (yes/no) versus A (yes/no). It consisted of 96 cancer survivors (average age 56 years; 88 % female; 68 % breast cancer). Fatigue was assessed by the brief fatigue inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A.<b>RESULTS: </b>Analyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P = 0.002, Std. error = 0.32, effect size (ES) = 0.46; FACIT-Fatigue: P < 0.001, Std. error = 1.74, ES = 0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps > 0.40) nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue.<b>CONCLUSIONS: </b>CBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve cancer-related fatigue (CRF) and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.
BACKGROUND: Breast cancer chemotherapy is associated with a decline in measured cardiorespiratory fitness and increased fatigue. Physical activity has emerged as a feasible intervention to limit these side effects. Quantitative evaluation is necessary to propose a better-adapted physical activity and to evaluate efficacy.
AIM: We undertook a prospective study to assess the effects of a home-based adapted physical activity (APA) program on aerobic capacity, strength, and fatigue in women treated with adjuvant or neoadjuvant chemotherapy for breast cancer versus usual care.
DESIGN: This was an open two-arm, randomized controlled trial.
SETTING: Study included outpatient groups in the Department of Physiology and Medical Oncology of a hospital in France.
POPULATION: Forty-four patients treated with adjuvant or neoadjuvant chemotherapy for breast cancer.
METHODS: Patients were randomly assigned to a control group or an APA group. Intervention consisted of a 3-week, home-based, supervised, combined APA program (endurance and resistance training) during 27 weeks. The primary endpoint was cardiopulmonary function assessed by maximal peak oxygen consumption (VO2peak). Secondary endpoints included a 6-minute Walking Test (6MWT), and assessment of muscular strength, fatigue, quality of life, physical activity level, and anxiety/depression.
RESULTS: At 27 weeks, VO2peak increased by 1.83±0.68 ml.min-1.kg-1 in the APA group (P=0.009) and decreased by 1.31±0.65 mL.min-1.kg-1 in the control group (P=0.046). The difference between the two groups was not significant (2.26±1.53 mL.min-1.kg-1, P=0.140) in intention-to-treat analysis, but it was significant in per protocol analysis (3.49±1.64 mL.min-1.kg-1, P=0.049). At 27 and 54 weeks, no significant differences were observed between the two groups for the cardiopulmonary exercise test, 6MWT, quadriceps strength, or quality of life.
CONCLUSIONS: In breast cancer patients, a home-based supervised program during chemotherapy and radiotherapy treatment may be safe, feasible and increase VO2peak. In this study, heavy evaluation tests explain patient's non-adherence and do not permit to obtain statistically significant results between APA and control groups.
CLINICAL REHABILITATION IMPACT: Aerobic home-based adapted physical activity is beneficial on aerobic capacity.
The primary aim of this study was to evaluate the benefits of resistance training ( RT) on quality of life ( QOL) and fatigue in breast cancer survivors as an adjunct to usual care. We recruited 39 women who had survived breast cancer [mean age (y) 51.9 ± 8.8; time since diagnosis (m) 11.6 ± 13.2]. Primary outcomes were fatigue as assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue ( FACIT) scale and QOL as assessed by the Functional Assessment of Cancer Therapy - General ( FACT-G) scale. ANCOVA was used to assess the change in the primary outcomes while controlling for baseline values, with effect sizes (ES) displayed as partial Eta squared. The experimental group received supervised RT 3 days per week in a university clinic for 16 weeks. Perceptions of fatigue improved significantly in the RT group compared to controls [mean ( SD) 6.7 (7.5) points vs. 1.5 (3.7) points], ( P = 0.006, ES = 0.20) as did QOL [6.9 (8.5) points vs. 1.6 (4.4) points], ( P = 0.015, ES = 0.16). We demonstrated both statistically and clinically important improvements in fatigue and QOL in response to RT in breast cancer survivors.
<b>PURPOSE: </b>This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.<b>METHODS: </b>The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n = 25), who received 12 weeks of moderate intensity walking, or the control group (n = 25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.<b>RESULTS: </b>The intervention had positive effects on fatigue (F = 5.77, p = 0.02), self-esteem (F = 8.93, p ≤ 0.001), mood (F = 4.73, p = 0.03) and levels of physical activity (x (2) = 17.15, p = 0.0011) but not anxiety (F = 0.90, p = 0.35) and depression (F = 0.26, p = 0.60) as assessed using the HADS. We found an 80% adherence rate to completing the 12-week intervention and recording weekly logs.<b>CONCLUSION: </b>This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.<b>Trial Registration: </b>Current Controlled Trials ISRCTN50709297.
<b>PURPOSE: </b>Following treatment, haematological cancer (HEM) patients exhibit significant physical deconditioning and psychological distress. Exercise has been shown as a clinically effective and safe intervention for cancer patients, with the potential to reverse the deleterious effects following treatment. Our aim was to investigate the efficacy of a 12-week exercise rehabilitation on cancer-related fatigue (CRF) and associated outcomes in HEM patients post-treatment.<b>METHODS: </b>Patients with a HEM were recruited to participate in a 12-week exercise rehabilitation intervention post-treatment. Pre-, post- and follow-up assessments were conducted on outcome measures including CRF, quality of life (QoL), psychological distress, cardiovascular fitness, muscle strength (MS) and body composition. Patients were given tailored exercise programmes comprising aerobic and resistance exercises, carried out three times per week for 12 weeks in local gyms and clinics. Usual-care participants were offered a delayed, tailored 12-week exercise intervention after the initial study period.<b>RESULTS: </b>Thirty-seven patients (49 % recruitment rate) were randomly assigned to the 12-week exercise rehabilitation (n = 18) or usual care (n = 19) with a 91 % adherence to the exercise intervention. Following the exercise programme, significant improvements were seen in CRF (p = 0.01), cardiovascular fitness (p ≤ 0.001), QoL (p ≤ 0.001), MS (p ≤ 0.001) and body composition (p = 0.001), with moderate to large effects for all primary outcomes. Patient follow-up at 24 weeks demonstrated outcome maintenance in the exercise rehabilitation group and significant improvements in outcomes in usual-care patients following participation in a delayed exercise programme. There were no adverse reactions or study withdrawals.<b>CONCLUSIONS: </b>A 12-week exercise rehabilitation programme resulted in significant statistical (p ≤ 0.05) and clinical improvements in CRF and additional outcomes in HEM patients following treatment. Additionally, a 12-week delayed exercise programme showed similar significant improvements in patient outcomes.<b>Trial Registration: </b>Australian New Zealand Clinical Trials Registry ACTRN12609000450213.
BACKGROUND: Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue.
METHODS: This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks.
RESULTS: Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups.
CONCLUSIONS: A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.
<b>PURPOSE: </b>Fatigue is a common problem among multiple myeloma (MM) patients. Armodafinil is a drug known to promote wakefulness, which is related to modafinil, a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents. We investigated whether armodafinil could reduce cancer-related fatigue in MM patients.<b>METHODS: </b>This double-blind, placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue. Patients were randomized to one of two arms: treatment-only, with armodafinil given at 150 mg/daily for 56 days, or placebo-first, with placebo given on days 1-28, followed by armodafinil administered at 150 mg daily on days 29-56. Fatigue was measured on days 1 (pre-dose: baseline), 15, 28, 43, and 56 using seven separate assessments, including four patient-reported outcomes of fatigue and related quality of life measures, as well as three objective measures of cognitive function.<b>RESULTS: </b>Overall toxicities were similar between treatment groups. No significant differences were observed between the placebo-first and the treatment-only arms after 28 days. Treatment with armodafinil for 28 additional days did not produce responses. Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline. Placebo-first patients improved on eight additional measures (one patient-reported measure, six subscales, and one objective task), suggesting a strong placebo effect in this patient population.<b>CONCLUSIONS: </b>Evaluation and treatment of cancer-related fatigue continues to be challenging; a clear definition of this symptom and better assessment tools are needed.
Multiple exercise interventions have shown beneficial effects on fatigue and quality of life (QoL) in cancer patients, but various psychosocial interventions as well. It is unclear to what extent the observed effects of exercise interventions are based on physical adaptations or rather on psychosocial factors associated with supervised, group-based programs. It needs to be determined which aspects of exercise programs are truly effective. Therefore, we aimed to investigate whether resistance exercise during chemotherapy provides benefits on fatigue and QoL beyond potential psychosocial effects of group-based interventions. One-hundred-one breast cancer patients starting chemotherapy were randomly assigned to resistance exercise (EX) or a relaxation control (RC) group. Both interventions were supervised, group-based, 2/week over 12 weeks. The primary endpoint fatigue was assessed with a 20-item multidimensional questionnaire, QoL with the EORTC QLQ-C30/BR23. Analyses of covariance for individual changes from baseline to Week 13 were calculated. In RC, total and physical fatigue worsened during chemotherapy, whereas EX showed no such impairments (between-group p = 0.098 and 0.052 overall, and p = 0.038 and 0.034 among patients without severe baseline depression). Differences regarding affective or cognitive fatigue were not significant. Benefits of EX were also seen to affect role and social function. Effect sizes were between 0.43 and 0.48. Explorative analyses indicated significant effect modification by thyroxin use (p-interaction = 0.044). In conclusion, resistance exercise appeared to mitigate physical fatigue and maintain QoL during chemotherapy beyond psychosocial effects inherent to supervised group-based settings. Thus, resistance exercise could be an integral part of supportive care for breast cancer patients undergoing chemotherapy.
