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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)

Phase 3
18 Years
Open (Enrolling)
Physiological Stress

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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)


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.

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

- Participation in another clinical trial with quality of life or functional status as
a primary endpoint

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Physical and Mental Functioning

Outcome Description:

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 hematopoietic cell transplantation (HCT) using an intention to treat analysis.

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Stephanie J Lee, M.D., M.P.H.

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

January 2015

Related Keywords:

  • Physiological Stress
  • exercise
  • stress management
  • post transplant
  • physical and emotional relaxation



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rush University Medical Center Chicago, Illinois  60612-3824
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
City of Hope National Medical Center Los Angeles, California  91010
University of Minnesota Minneapolis, Minnesota  55455
Oregon Health & Science University Portland, Oregon  97201
University of Michigan Medical Center Ann Arbor, Michigan  48104-0914
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Atlanta, Georgia  30322
Karmanos Cancer Institute Detroit, Michigan  48201
University Hospitals of Cleveland/Case Western Cleveland, Ohio  44106
Baylor College of Medicine/The Methodist Hospital Houston, Texas  77030-2399
Virginia Commonwealth University, MCV Hospital Richmond, Virginia  23298
University of Florida College of Medicine Gainesville, Florida  32610
Washington University, Barnes Jewish Hospital St. Louis, Missouri  63110
Fox Chase, Temple University Philadelphia, Pennsylvania  19111-2442
Blood & Marrow Transplant Program at Northside Hospital Atlanta, Georgia  30342