NCT00833898

Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)

Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: A stress management intervention may be more effective than usual care in improving quality of life in caregivers of patients undergoing bone marrow transplant. PURPOSE: This randomized phase III trial is studying a stress management intervention for caregivers of patients undergoing bone marrow transplant.

Detailed description

Specific Aims * Further validate a unique saliva collection device in a randomized controlled study of a psychoeducation, paced respiration, and relaxation (PEPRR) intervention for caregivers of patients undergoing bone marrow transplantation. * Evaluate the suitability of paced respiratory training using RESPeRATE™ for these caregivers. * Determine the efficacy of a PEPRR intervention on behavioral (stress level, mood and overall health) and physiological (neuroendocrine function, immune function, and sleep) outcomes of these caregivers. OUTLINE: Caregivers are randomized to 1 of 2 groups. * Group I (treatment as usual \[TAU\]): Caregivers and patients attend a 2-hour orientation class that provides an overview of the transplant process, information regarding financial issues and resources that may be available to the patient and caregiver, a review of caregiver duties, dietary restrictions post-transplantation, a brief introduction to stress and stress management, and hands-on training of how to care for a central venous catheter. Patients also receive information in the form of a written manual that provides in-depth information about transplant, including how the transplant works, what to expect, caregiver duties, graft-vs-host disease, and when to contact medical staff for assistance. A voluntary 1-hour weekly caregiver support group is offered on the inpatient BMT unit. * Group II (psychoeducation, paced respiration, and relaxation \[PEPRR\]): Caregivers and patients attend a 2-hour orientation class identical to group I. Caregivers also participate in the PEPRR intervention comprising an individualized stress management component and educational component that addresses the psychosocial needs of the caregivers. It also provides self-care and adaptive coping skills. The stress management component addresses caregivers' perception of potential stressors (primary appraisal); perceived ability to control or manage the stressor (secondary appraisal); ability to exert control and cope with the stressor (coping effort); and ongoing evaluation of the stressor and their perceived ability of managing the stressor (reappraisal) and applies coping strategies such as relaxation, prioritizing, goal setting, pacing, and communicating needs. The PEPRR intervention consists of 8 sessions (4 weekly 60-minute sessions followed by 4 biweekly 60-minute sessions) that cover the 100-day period of caregiving post-transplantation. Caregivers also undergo paced respiratory (RESPeRATE™) training for 15 minutes once daily over 12 weeks that measures caregiver adherence and compliance to the relaxation program. Caregivers and patients undergo psychosocial assessments at approximately 1-3 months prior to randomization and transplantation and again at 1, 3, 6, and 12 months after transplantation. Caregivers also complete questionnaires to assess their stress (PSS, CRA, and IES), mood (POMS, CES-D, and STAI), sleep (PSQI), and health (SF-36). Caregivers undergo blood and saliva sample collection at baseline and periodically during study for biomarker analysis (e.g., neuroendocrine and immune markers). Caregivers wear an activity watch (actimeter) during each saliva sample collection period.

Conditions

• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
DEVICE	Paced respiration as part of PEPRR	The FDA approved RESPeRATE™ is the size of a portable compact disk (CD) player with a visual display, an elastic belt-type respiratory sensor, and a set of headphones. During a relaxation session, the device analyzes respiratory pattern of the subject and creates a melody of pleasant tones selected by the subject (one for inhalation and one for exhalation). The subjects can observe a cartoon figure on the screen of the device that indicates their inhalation and exhalation. The subject synchronizes their breathing to these tones as the exhalation tone is gradually increased in duration with a target of less than 10 breaths/minute. Subjects were encouraged to use RESPeRATE 3-5 times a week for 20 minutes.
BEHAVIORAL	PEPRR	PEPRR consist of 8 sessions, each lasting approximately 60min. The first 4 sessions are weekly, followed by biweekly mtgs for the remaining 4 sessions. Sessions begin the week that the patient receives the transfusion of donor cells. Session 1-4 are conducted at the hospital where the patients receive their transplant. Once discharged from the hospital, sessions will be conducted at the outpatient BMT clinic to coincide with patients' post-transplant visits. Sessions are devoted to a separate topic with the goal of assisting the caregiver in development \& application of various stress-mgmt techniques such as effective problem-solving, identifying \& challenging cognitive distortions, relaxation techniques, coping skills training, effective use of social support \& goal setting.

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-02-02
• Last updated: 2015-12-09
• Results posted: 2015-09-10

Locations

2 sites across 1 country: United States