NCT01278927

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Physiological Stress

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	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.
BEHAVIORAL	Stress Management	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
BEHAVIORAL	Exercise and Stress Management	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
OTHER	Standard Care	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-01-01
• Completion: 2014-11-01
• First posted: 2011-01-19
• Last updated: 2022-12-08
• Results posted: 2015-12-17

Locations

19 sites across 1 country: United States