At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
In Brief
A Phase 3 clinical trial evaluating Paced respiration as part of PEPRR and PEPRR for Hematopoietic/Lymphoid Cancer. Completed, enrolled 298 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.