Hematopoietic/Lymphoid CancerPhase 3NCT00833898
Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
A Phase 3 study testing Paced respiration as part of PEPRR and PEPRR in people with Hematopoietic/Lymphoid Cancer, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer
- What is being tested?
- Paced respiration as part of PEPRR and PEPRR
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- PRIOR CONCURRENT THERAPY:
- No concurrent steroid medications (caregiver)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Presbyterian/St. Luke's Medical Center (PSLMC) - Denver Midtown
Denver, Colorado, 80218
About this study
Official title: Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
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.
Read the 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.
- Conditions
- Hematopoietic/Lymphoid Cancer
- Being tested
- Paced respiration as part of PEPRR, PEPRR
- Keywords
- depression, stress, caregiving, anxiety, psychoeducation intervention, psycho-oncology
- Medical subject headings
- Hematologic Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced respiration as part of PEPRRDevice
Also called RESPeRATE™
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.
PEPRRBehavioural
Also called Psychoeducation & Paced Respiration/Relaxation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Paced respiration as part of PEPRR; Behavioral: PEPRR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
Secondary outcomes (19)
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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).
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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).
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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).
Measured: Baseline (prior to transplant), 1 and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
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.
Measured: Baseline (prior to transplant) and 3 post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic/Lymphoid CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Laudenslager, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833898
- Sponsor's protocol ID
- 08-0303
- Other IDs
- 1R01CA126971-01A1
- Status last verified
- Nov 2015
- First submitted
- 30 Jan 2009
- Last updated
- 9 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23440998Laudenslager 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.
PubMed 25961767Ouseph 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.
PubMed 25478136
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
- ClinicalTrials.gov ID
- NCT00833898
- Acronym / sponsor ID
- 08-0303
- Conditions
- Hematopoietic/Lymphoid Cancer
- Keywords
- depression, stress, caregiving, anxiety, psychoeducation intervention, psycho-oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 10 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregiver Control | No intervention | –Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care. |
| Caregiver Intervention | Experimental | Device: Paced respiration as part of PEPRR, Behavioral: PEPRROrientation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- DISEASE CHARACTERISTICS (Meets all of the following criteria):
- PATIENT CHARACTERISTICS:
Key exclusion criteria (2 listed)
- PRIOR CONCURRENT THERAPY:
- No concurrent steroid medications (caregiver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paced respiration as part of PEPRRAlso: RESPeRATE™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. | Device | Caregiver Intervention |
| PEPRRAlso: Psychoeducation & Paced Respiration/RelaxationPEPRR 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. | Behavioural | Caregiver Intervention |
Primary outcome
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
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.
Physiological - Cortisol Awakening Response (CAR)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
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.
19 secondary outcomes
Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Stress as Measured by the Impact of Events Scale (IES)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Area Under the Curve for Salivary Cortisol (AUCc)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Area Under the Curve for Salivary DHEA (AUCd)
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity
Time frame: Baseline (prior to transplant), 1 and 3 post transplant
Plasma C-reactive Protein (CRP)
Time frame: Baseline (prior to transplant) and 3 post transplant
Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)
Time frame: Baseline (prior to transplant) and 3 post transplant
Plasma Inflammatory Marker Interleukin 6 (IL-6)
Time frame: Baseline (prior to transplant) and 3 post transplant
Plasma Inflammatory Marker Interleukin 4 (IL-4)
Time frame: Baseline (prior to transplant) and 3 post transplant
Plasma Inflammatory Marker Interleukin 10 (IL-10)
Time frame: Baseline (prior to transplant) and 3 post transplant
Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)
Time frame: Baseline (prior to transplant) and 3 post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23440998Simoneau 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.
- Results publication: PubMed 25961767Laudenslager 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.
- Results publication: PubMed 25478136Ouseph 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Laudenslager, PhD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paced respiration as part of PEPRR and PEPRR in people with Hematopoietic/Lymphoid Cancer, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS) (time frame: Baseline (prior to transplant), 1 and 3 post transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833898, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015; AzTrials last refreshed its copy on 26 Oct 2026.