Clinical trial NCT00833898: Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
Official title: Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic/Lymphoid Cancer
Keywords: depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-02
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Physiological - Cortisol Awakening Response (CAR)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
Secondary outcomes:
measure: Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Stress as Measured by the Impact of Events Scale (IES)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Area Under the Curve for Salivary Cortisol (AUCc)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Area Under the Curve for Salivary DHEA (AUCd)
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity
timeFrame: Baseline (prior to transplant), 1 and 3 post transplant
measure: Plasma C-reactive Protein (CRP)
timeFrame: Baseline (prior to transplant) and 3 post transplant
measure: Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)
timeFrame: Baseline (prior to transplant) and 3 post transplant
measure: Plasma Inflammatory Marker Interleukin 6 (IL-6)
timeFrame: Baseline (prior to transplant) and 3 post transplant
measure: Plasma Inflammatory Marker Interleukin 4 (IL-4)
timeFrame: Baseline (prior to transplant) and 3 post transplant
measure: Plasma Inflammatory Marker Interleukin 10 (IL-10)
timeFrame: Baseline (prior to transplant) and 3 post transplant
measure: Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)
timeFrame: Baseline (prior to transplant) and 3 post transplant
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian/St. Luke's Medical Center (PSLMC) - Denver Midtown
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mark Laudenslager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Kilbourn K, Spradley J, Grzywa-Cobb R, Philips S, McSweeney P, Laudenslager ML. Elevated peri-transplant distress in caregivers of allogeneic blood or marrow transplant patients. Psychooncology. 2013 Sep;22(9):2064-70. doi: 10.1002/pon.3259. Epub 2013 Feb 25.
citation: Laudenslager ML, Simoneau TL, Kilbourn K, Natvig C, Philips S, Spradley J, Benitez P, McSweeney P, Mikulich-Gilbertson SK. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant. 2015 Aug;50(8):1110-8. doi: 10.1038/bmt.2015.104. Epub 2015 May 11.
citation: Ouseph R, Croy C, Natvig C, Simoneau T, Laudenslager ML. Decreased mental health care utilization following a psychosocial intervention in caregivers of hematopoietic stem cell transplant patients. Ment Illn. 2014 Mar 25;6(1):5120. doi: 10.4081/mi.2014.5120. eCollection 2014 Mar 4.