Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
Condition: Hematopoietic/Lymphoid Cancer
Intervention: Paced respiration as part of PEPRR; PEPRR
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DISEASE CHARACTERISTICS (Meets all of the following criteria):

               -  Patient undergoing allogeneic bone marrow transplantation (BMt)

               -  Primary caregiver of a BMT patient

               -  Has provided care for the patient for at least 50 days of the required 100 days
                  of caregiving following transplant (e.g., 50% of the total time)

          -  PATIENT CHARACTERISTICS:

               -  Able to read and speak English

               -  Has telephone access

               -  No serious medical condition likely to influence immune and neuroendocrine
                  parameters (caregiver)

               -  Alcohol consumption limited to < 2 drinks/day (caregiver)

               -  No history of a psychiatric illness unrelated to the experience as a caregiver
                  within the past 18 months (caregiver)

               -  No history of a psychiatric illness unrelated to the BMT within the past 18
                  months (patient)

        Exclusion Criteria:

        - PRIOR CONCURRENT THERAPY:

        • No concurrent steroid medications (caregiver)