NCT01278927

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
711

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

January 17, 2011

Results QC Date

November 24, 2014

Last Update Submit

December 6, 2022

Conditions

Physiological Stress

Keywords

exercisestress managementpost transplantphysical and emotional relaxation

Outcome Measures

Primary Outcomes (1)

  • Functional Status

    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 (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.

    100 days

Secondary Outcomes (7)

  • Symptoms

    100 days

  • Cancer and Treatment Distress (CTXD)

    100 days

  • The Pittsburgh Sleep Quality Index (PSQI)

    100 days

  • Nausea

    100 days

  • Days of Hospitalization

    100 days

  • +2 more secondary outcomes

Study Arms (4)

Exercise

ACTIVE COMPARATOR

Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.

Behavioral: Exercise

Stress Management

ACTIVE COMPARATOR

Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.

Behavioral: Stress Management

Exercise and Stress Management

ACTIVE COMPARATOR

Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.

Behavioral: Exercise and Stress Management

Standard Care

OTHER

Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).

Other: Standard Care

Interventions

ExerciseBEHAVIORAL

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.

Also known as: Physical activities, Musculoskeletal, Exertian level
Exercise
Stress ManagementBEHAVIORAL

Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.

Also known as: Active relaxation, Deep breathing, Positive thinking, Relaxing
Stress Management
Exercise and Stress ManagementBEHAVIORAL

Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.

Also known as: Physical and emotional relaxation, Active relaxation
Exercise and Stress Management
Standard CareOTHER

Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.

Also known as: General care, Psychosocial care
Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence
  • Participation in another clinical trial with quality of life or functional status as a primary endpoint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33624, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Blood & Marrow Transplant Program at Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48105-2967, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University, Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10174, United States

Location

University Hospitals of Cleveland/Case Western

Cleveland, Ohio, 44106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Fox Chase, Temple University

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine/The Methodist Hospital

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University, MCV Hospital

Richmond, Virginia, 23298, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (2)

  • Jacobsen PB, Le-Rademacher J, Jim H, Syrjala K, Wingard JR, Logan B, Wu J, Majhail NS, Wood W, Rizzo JD, Geller NL, Kitko C, Faber E, Abidi MH, Slater S, Horowitz MM, Lee SJ. Exercise and stress management training prior to hematopoietic cell transplantation: Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0902. Biol Blood Marrow Transplant. 2014 Oct;20(10):1530-6. doi: 10.1016/j.bbmt.2014.05.027. Epub 2014 Jun 6.

    PMID: 24910380RESULT

  • Wood WA, Le-Rademacher J, Syrjala KL, Jim H, Jacobsen PB, Knight JM, Abidi MH, Wingard JR, Majhail NS, Geller NL, Rizzo JD, Fei M, Wu J, Horowitz MM, Lee SJ. Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902). Cancer. 2016 Jan 1;122(1):91-8. doi: 10.1002/cncr.29717. Epub 2015 Oct 6.

    PMID: 26439325RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseRestraint, PhysicalStandard of CarePsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBehavior ControlTherapeuticsImmobilizationInvestigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Adam Mendizabal
Organization
The EMMES Corporation
amendizabal@EMMES.com
301-251-1161

Study Officials

  • Mary Horowitz, MD

    Center for International Blood and Marrow Transplant Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

November 1, 2014

Last Updated

December 8, 2022

Results First Posted

December 17, 2015

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

Results will be published in a manuscript

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Within 6 months of official study closure at participating sites.
Access Criteria
Available to the public
More information

Locations

US(19)