Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)

Physiological Stress Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278927
• Other study ID #: BMTCTN0902
• Secondary ID: U01HL069294BMT C
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: November 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 adherence

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

Related Conditions & MeSH terms

• Physiological Stress

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Blood & Marrow Transplant Program at Northside Hospital	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals of Cleveland/Case Western	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Baylor College of Medicine/The Methodist Hospital	Houston	Texas
United States	University of Minnesota	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Fox Chase, Temple University	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University, MCV Hospital	Richmond	Virginia
United States	Washington University, Barnes Jewish Hospital	Saint Louis	Missouri
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Marrow Donor Program

Country where clinical trial is conducted

United States, 

References & 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 transplantat — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Symptoms	Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.	100 days
Secondary	Cancer and Treatment Distress (CTXD)	Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.	100 days
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.	100 days
Secondary	Nausea	Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.	100 days
Secondary	Days of Hospitalization	The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.	100 days
Secondary	SF-36 Late Outcomes	The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.	6 months
Secondary	Survival	Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.	6 months and 1 year

External Links

•   Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
•   National Marrow Donor Program