Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise and Stress Management Post Autologous and Allogeneic Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
The EMMES Corporation
ClinicalTrials.gov Identifier:
NCT01278927
First received: January 17, 2011
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Physiological Stress
Behavioral: Exercise
Behavioral: Stress Management
Behavioral: Exercise and Stress Management
Other: Standard Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by The EMMES Corporation:

Primary Outcome Measures:
  • Physical and Mental Functioning [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Symptoms [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    To compare symptoms (fatigue, pain, sleep, nausea, cancer and treatment distress) at 100 days post HCT among patients who provide a Day 100 self-assessment (conditional analysis).

  • Days of Hospitalization [ Time Frame: 100 days ] [ Designated as safety issue: No ]
    The number of hospital days within the first 100 days after HCT will be collected for patients surviving at least 100 days.

  • Late Outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess durability of effects by comparing functional status and symptoms at 6 months post HCT.

  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 700
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise
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
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.
Other Names:
  • Physical activities
  • Musculoskeletal
  • Exertian level
Active Comparator: Stress Management
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
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
Other Names:
  • Active relaxation
  • Deep breathing
  • Positive thinking
  • Relaxing
Active Comparator: 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. 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
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
Other Names:
  • Physical and emotional relaxation
  • Active relaxation
Standard Care
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
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Other Names:
  • General care
  • Psychosocial care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278927

  Show 19 Study Locations
Sponsors and Collaborators
The EMMES Corporation
Blood and Marrow Transplant Clinical Trials Network
Investigators
Study Chair: Stephanie J Lee, M.D., M.P.H. Fred Hutchinson Cancer Research Center
Study Chair: Paul B Jacobsen, Ph.D. H. Lee Moffitt Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: The EMMES Corporation
ClinicalTrials.gov Identifier: NCT01278927     History of Changes
Other Study ID Numbers: 0902, U01HL069294, 0902
Study First Received: January 17, 2011
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The EMMES Corporation:
exercise
stress management
post transplant
physical and emotional relaxation

ClinicalTrials.gov processed this record on November 25, 2014