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

Hematopoietic/Lymphoid Cancer Clinical Trial

Official title:

Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833898
• Other study ID #: 08-0303
• Secondary ID: 1R01CA126971-01A
• Status: Completed
• Phase: Phase 3
• First received: January 30, 2009
• Last updated: November 6, 2015
• Start date: November 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer

Intervention

Device:
• Paced respiration as part of PEPRR
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.

Behavioral:
• PEPRR
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.

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Presbyterian/St. Luke's Medical Center (PSLMC) - Denver Midtown	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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: — View 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.2014.51 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)	The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)	The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)	POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 - 200, with higher score indicating more mood disturbance.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)	The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)	The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)	The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Stress as Measured by the Impact of Events Scale (IES)	The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)	The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)	The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Area Under the Curve for Salivary Cortisol (AUCc)	The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Area Under the Curve for Salivary DHEA (AUCd)	The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity	The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).	Baseline (prior to transplant), 1 and 3 post transplant	No
Secondary	Plasma C-reactive Protein (CRP)	Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.	Baseline (prior to transplant) and 3 post transplant	No
Secondary	Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)	Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.	Baseline (prior to transplant) and 3 post transplant	No
Secondary	Plasma Inflammatory Marker Interleukin 6 (IL-6)	Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.	Baseline (prior to transplant) and 3 post transplant	No
Secondary	Plasma Inflammatory Marker Interleukin 4 (IL-4)	Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.	Baseline (prior to transplant) and 3 post transplant	No
Secondary	Plasma Inflammatory Marker Interleukin 10 (IL-10)	Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.	Baseline (prior to transplant) and 3 post transplant	No
Secondary	Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)	Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.	Baseline (prior to transplant) and 3 post transplant	No