Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)
NCT01278927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 711
Last updated 2022-12-08
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.
Conditions
- Physiological Stress
Interventions
- 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.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Blood and Marrow Transplant Clinical Trials Network
collaborator NETWORK -
National Cancer Institute (NCI)
collaborator NIH -
National Marrow Donor Program
collaborator OTHER -
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Mary Horowitz, MD · Center for International Blood and Marrow Transplant Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2013-01-31
- Completion
- 2014-11-30
Countries
- United States
Study Locations
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