Phase 3
N=148
Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
Hematopoietic/Lymphoid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00833898 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS) — 23.5; 22.7; 21.6; 22.0 units on a scale — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paced respiration as part of PEPRR (Device); PEPRR (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS) |
23.5; 22.7; 21.6; 22.0; 23.0; 20.0 | 0.020 sig |
| PRIMARY Physiological - Cortisol Awakening Response (CAR) |
0.35; 0.25; 0.33; 0.36; 0.33; 0.52 | 0.15 |
| SECONDARY Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD) |
15.9; 14.6; 13.8; 13.6; 16.3; 12.1 | 0.029 sig |
| SECONDARY State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI) |
42.4; 38.9; 38.8; 38.0; 41.6; 34.7 | 0.003 sig |
| SECONDARY Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS) |
66.8; 61.0; 58.0; 59.4; 65.2; 53.0 | 0.012 sig |
| SECONDARY Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA) |
10.4; 10.2; 10.8; 10.8; 10.9; 10.6 | 0.40 |
| SECONDARY Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score |
11.1; 11.4; 11.2; 11.2; 11.2; 11.0 | 0.44 |
| SECONDARY Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M) |
42.7; 45.1; 43.8; 45.7; 43.5; 47.0 | 0.75 |
| SECONDARY Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P) |
53.8; 54.7; 54.0; 52.9; 53.7; 54.0 | 0.17 |
| SECONDARY Stress as Measured by the Impact of Events Scale (IES) |
31.4; 29.8; 31.0; 29.1; 30.3; 28.4 | 0.97 |
| SECONDARY The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC) |
-0.12; -0.12; -0.10; -0.12; -0.12; -0.11 | 0.55 |
| SECONDARY The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA) |
-0.11; -0.13; -0.13; -0.15; -0.13; -0.17 | 0.30 |
| SECONDARY Area Under the Curve for Salivary Cortisol (AUCc) |
3.85; 3.65; 3.78; 3.80; 3.77; 3.68 | 0.67 |
| SECONDARY Area Under the Curve for Salivary DHEA (AUCd) |
1.44; 1.64; 1.52; 1.41; 1.56; 1.35 | 0.013 sig |
| SECONDARY Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity |
-1.01; -1.07; -1.09; -1.17; -1.09; -1.27 | 0.80 |
| SECONDARY Plasma C-reactive Protein (CRP) |
0.18; 0.27; 0.03; -0.10 | 0.26 |
| SECONDARY Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta) |
.39; .39; .39; .39 | .58 |
| SECONDARY Plasma Inflammatory Marker Interleukin 6 (IL-6) |
-0.33; -0.56; -0.13; -0.45 | 0.53 |
| SECONDARY Plasma Inflammatory Marker Interleukin 4 (IL-4) |
1.56; 1.56; 1.56; 1.56 | .18 |
| SECONDARY Plasma Inflammatory Marker Interleukin 10 (IL-10) |
1.72; 1.60; 1.60; 1.60 | .43 |
| SECONDARY Plasma Inflammatory Marker Tumor Necrosis Factor (TNF) |
4.70; 4.70; 4.70; 4.70 | .43 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00833898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.