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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Hematopoietic/Lymphoid Cancer

Treatments: Behavioral: PEPRR; Device: Paced respiration as part of PEPRR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00833898

1R01CA126971-01A1 (U.S. NIH Grant/Contract)

08-0303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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298 participants in 2 patient groups

Caregiver Control

No Intervention group

Description:

Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.

Caregiver Intervention

Experimental group

Description:

Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), which included one-on-one psychoeducation, stress management intervention, with paced respiration.

Treatment:

Device: Paced respiration as part of PEPRR

Behavioral: PEPRR