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)

Trial Information

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)

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.