Blood and Marrow Transplant Clinical Trials Network (BMT CTN) A Phase III Randomized, Multicenter Trial Testing Whether Exercise or Stress Management Improves Functional Status and Symptoms of Autologous and Allogeneic Recipients (0902)
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January 2011 – November 2014
April 4, 2019
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The study aimed to determine whether self-directed exercise and/or stress management improves self-reported physical and mental functioning compared to standard care in patients following autologous or allogeneic hematopoietic cell transplantation (HCT).
HCT is associated with numerous adverse symptoms, such as nausea, fatigue, and sleep disturbance, which are a detriment to patient short and long-term quality of life as a result of decreased physical and mental health. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take years to reach this goal. Clinical trials have shown that training in stress management techniques and participation in formal exercise programs each offered in isolation are effective in improving quality of life in patients receiving standard-dose chemotherapy and HCT. Review of these studies suggests that stress management interventions primarily improve mental health outcomes and nausea. The impact of exercise training interventions is more variable; most studies report physical health benefits, with some studies also reporting mental health benefits. Small studies suggest that combining stress management training and exercise are feasible and well-tolerated, but whether the combination provides an additive or synergistic impact on quality of life outcomes had not been directly investigated prior to this study.
Patients with autologous or allogeneic HCT planned within 6 weeks were eligible to participate if they were at least 18 years of age, could speak and read English, had the ability to exercise at low to moderate intensity, and did not require supplemental oxygen. Exclusion criteria included orthopedic, neurologic or other problems which prevented safe ambulation or protocol adherence, participation in another clinical trial with quality of life or functional status as a primary endpoint, planned anti-cancer therapies other than tyrosine kinase inhibitors or rituximab within 100 days after HCT, planned donor lymphocyte infusion within 100 days after HCT, and planned tandem transplant.
711 eligible patients at 21 US centers were enrolled between January 2011 and June 2012. 175 patients were randomized to standard of care, 180 were randomized to exercise only, 178 were randomized to stress management only, and 178 were randomized to exercise combined with stress management.
The study was designed as a phase III, randomized, controlled, multicenter trial. After enrollment and baseline patient self-reported information was collected, patients were randomized using a factorial design to one of four groups: exercise training, stress management training, the combination of exercise and stress management training, or usual care. The intervention was given prior to HCT as a 20-minute introduction to the self-directed program. Trained site personnel served as the interventionists who reviewed a pamphlet summarizing the main points of the self-directed program and gave the patients a DVD reinforcing the program. Patients received a diary in which they could track their participation in exercise and/or stress management. In addition, the interventionists reviewed the goals for use of the program, proper technique, and identification of barriers to engagement in exercise or stress management and plans to overcome them. The exercise component also included calculation of target heart rate and provision of a pedometer. The exercise goal was walking 3–5 times a week for at least 20–30 minutes at 50–75% of estimated heart rate reserve, consistent with guidelines for exercise in cancer patients developed by the American College of Sports Medicine. The stress management goal targeted paced abdominal breathing, progressive muscle relaxation with guided imagery, and coping self-statements to decrease and manage stress. The stress management component also included provision of a relaxation CD.
Participants completed self-reported assessments at enrollment and 30, 60, 100 and 180 days after transplant. The Medical Outcomes Questionnaire SF36 was used to measure quality of life, including a physical component summary (PCS) scale and mental component summary (MCS) scale, and eight subscales including a 2-item Bodily Pain subscale. Additional instruments included Cancer and Treatment Distress (CTX-D), Pittsburgh Sleep Quality Index (PSQI), and nausea as measured by 2 items formatted similar to the SF36 Bodily Pain subscale. To evaluate whether patients were engaging in the self-administered programs, the Leisure Score Index was administered to measure physical activity and a 5-item Stress Reduction Checklist was administered to measure participation in stress management activities. The co-primary endpoints were the SF-36 PCS and MCS scores at 100 days post-HCT. Secondary outcomes included hospital days within the first 100 days after graft infusion and survival.
There were no differences in the primary endpoints of the physical (PCS) and mental (MCS) component scales of the SF36 at day 100 among the groups based on an intention-to-treat analysis. There were no differences observed in overall survival, hospital days through day 100 post-HCT, or in other patient-reported outcomes, including treatment-related distress, sleep quality, pain, and nausea. Patients randomized to training in stress management reported more use of those techniques; patients randomized to exercise training did not report more physical activity. Although other studies have reported efficacy of more intensive interventions, brief training in an easy-to-disseminate format for either self-directed exercise or stress management was not effective in this trial.
Jacobsen PB, Le-Rademacher J, Jim H, et al. Exercise and stress management training prior to hematopoietic cell transplantation: Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0902. Biol Blood Marrow Transplant. 2014;20(10):1530-6.
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