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Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome

Phase 3
18 Years
Open (Enrolling)
Hematopoietic/Lymphoid Cancer

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Trial Information

Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome

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

- 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.

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)


- 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:


• No concurrent steroid medications (caregiver)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Behavioral - Stress level as measured by the Perceived Stress Scale (PSS)

Outcome Description:

Caregiver stress will be assessed with the Perceived Stress Scale (PSS) (Cohen et al., 1983), identifying the degree to which situations in life are perceived as stressful. Items on the PSS measure the degree to which the subjects feel their lives are unpredictable, uncontrollable and overwhelming on a 5 point Likert scale. The shorter 10-item scale was validated in 2,387 respondents across demographic characteristics (i.e. age, gender, socioeconomic status, race) (Cohen, Kessler, & Gordon, 1995) with superior psychometric properties (reliability alpha of 0.84).

Outcome Time Frame:

Baseline (prior to transplant), 1, 3, 6, 12 post transplant

Safety Issue:


Principal Investigator

Mark Laudenslager, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

June 2013

Related Keywords:

  • Hematopoietic/Lymphoid Cancer
  • depression
  • stress
  • caregiving
  • anxiety
  • psychoeducation intervention
  • psycho-oncology



University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Presbyterian/St. Luke's Medical Center (PSLMC) - Denver MidtownDenver, Colorado  80218