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

NCT00833898 | Completed Phase 3 Results DMC

• 2 other identifiers: 08-03031R01CA126971-01A1
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic/Lymphoid Cancer

Keywords

depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology

Outcome Measures

Primary Outcomes (2)

• Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)

  The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.

  Baseline (prior to transplant), 1 and 3 post transplant

• Physiological - Cortisol Awakening Response (CAR)

  Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.

  Baseline (prior to transplant), 1 and 3 post transplant

Secondary Outcomes (19)

• Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)

  Baseline (prior to transplant), 1 and 3 post transplant

• State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)

  Baseline (prior to transplant), 1 and 3 post transplant

• Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)

  Baseline (prior to transplant), 1 and 3 post transplant

• Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)

  Baseline (prior to transplant), 1 and 3 post transplant

• Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score

  Baseline (prior to transplant), 1 and 3 post transplant

Study Arms (2)

Caregiver Control

NO INTERVENTION

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

Caregiver Intervention

EXPERIMENTAL

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.

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

Interventions

Paced respiration as part of PEPRR DEVICE

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.

Also known as: RESPeRATE™

Caregiver Intervention

PEPRR BEHAVIORAL

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.

Also known as: Psychoeducation & Paced Respiration/Relaxation

Caregiver Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- PRIOR CONCURRENT THERAPY:
• No concurrent steroid medications (caregiver)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Presbyterian/St. Luke's Medical Center (PSLMC) - Denver Midtown

Denver, Colorado, 80218, United States

Location

Related Publications (3)

• 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.

  PMID: 23440998 BACKGROUND

• 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.

  PMID: 25961767 RESULT

• 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.

  PMID: 25478136 RESULT

MeSH Terms

Conditions

Hematologic Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Mark L. Laudenslager, PhD
• Organization: University of Colorado Denver

biel@ucdenver.edu

303-724-9279

Study Officials

• Mark Laudenslager, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 9, 2015
• Results First Posted: September 10, 2015

Record last verified: 2015-11

Locations

US (2)