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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278927 on ClinicalTrials.gov