Clinical trial · Interventional
Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)
Psychoeducation For BMT Caregivers: Biobehavioral Markers and Outcome
NCT00833898CI-TRIAL-00020125completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic/Lymphoid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paced respiration as part of PEPRR | Device | — | UNRESOLVED |
| PEPRR | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Caregiver Control
- description
- Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
- type
- EXPERIMENTAL
- label
- Caregiver Intervention
- description
- 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.
- interventionNames
- Device: Paced respiration as part of PEPRR
- Behavioral: PEPRR
Primary outcomes (2)
- measure
- Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDSimoneau 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
- RESULTLaudenslager 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
- RESULTOuseph 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