Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)

Study Overview
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Brief Summary
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This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.

Detailed Description
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Background: The adverse effects of hematopoietic cell transplantation (HCT) on short and long term quality of life are well documented. Patients experience numerous aversive symptoms (e.g., nausea, fatigue, and sleep disturbance) that are accompanied by declines in physical and mental well-being. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take 6 to 12 months or longer 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 has not been directly investigated. Design Narrative: The protocol is designed as a factorial trial with two interventions, exercise and stress management, which results in four treatment arms: standard care, exercise only, stress management only and the combination of exercise and stress management. The primary objective of this randomized phase III trial is to test the ability of exercise training or stress management training to improve physical and mental functioning at Day 100 post hematopoietic cell transplantation.

Official Title
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A Phase III Randomized, Multicenter Trial Testing Whether Exercise or Stress Management Improves Functional Status and Symptoms of Autologous and Allogeneic Recipients (BMT CTN #0902)

Conditions
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Physiological Stress

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Stress Management
* Behavioral: Exercise and Stress Management
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Able to speak and read English Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment Willing and able to provide informed consent. Stated willingness to comply with study procedures and reporting requirements Planned autologous or allogeneic transplantation within 6 weeks. Exclusion Criteria: Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence Participation in another clinical trial with quality of life or functional status as a primary endpoint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. | Behavioral: Exercise<br>* Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.<br>* Other names: Exertian level;|
| Active Comparator: Stress Management<br>Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient. | Behavioral: Stress Management<br>* Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.<br>* Other names: Relaxing;|
| Active Comparator: Exercise and Stress Management<br>Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient. | Behavioral: Exercise and Stress Management<br>* Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.<br>* Other names: Active relaxation;|
| Other: Standard Care<br>Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress). | Other: Standard Care<br>* Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.<br>* Other names: Psychosocial care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Status | To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state. | 100 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state. | 100 days | 
| Cancer and Treatment Distress (CTXD) | Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress. | 100 days | 
| The Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality. | 100 days | 
| Nausea | Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea. | 100 days | 
| Days of Hospitalization | The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days. | 100 days | 
| SF-36 Late Outcomes | The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state. | 6 months | 
| Survival | Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact. | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, stress management, post transplant, physical and emotional relaxation