Clinical trial · Interventional
Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence
NCT02037568CI-TRIAL-00030691completedN/AResults 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)
PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management psychoeducation will be expected to obtain a new set of coping skills that will allow them to better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected that improving caregiver status will improve patient quality of life.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fPER | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Caregiver Self-Directed
- description
- Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
- type
- EXPERIMENTAL
- label
- Caregiver Intervention
- description
- Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
- interventionNames
- Behavioral: fPER
Primary outcomes (2)
- measure
- Functional Assessment of Cancer Treatment - Blood/Marrow Transplant
- timeFrame
- Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * DISEASE CHARACTERISTICS (Meets all of the following criteria): * Patient undergoing allogeneic hematopoietic stem cell transplant (HSCT) * Caregiver: the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation, and available if randomized to the fPER group to participate in the majority of intervention sessions * PATIENT CHARACTERISTICS: * Able to read and speak English * Has telephone access * CAREGIVER CHARACTERISTICS: * Able to read and speak English * Willingness to use a Smartphone * No serious medical condition likely to influence cortisol assessment in their hair * Alcohol consumption limited to \< 2 drinks/day * At least 18 years of age Exclusion Criteria: * PRIOR CONCURRENT THERAPY: * No history of a psychiatric illness unrelated to the HSCT within the past 18 months * No steroid medications (caregiver)
References
Publications (2)
- DERIVEDSannes TS, Ranby KW, Yusufov M, Brewer BW, Jacobs JM, Callan S, Ulrich GR, Pensak NA, Natvig C, Laudenslager ML. More often than not, we're in sync: patient and caregiver well-being over time in stem cell transplantation. Health Qual Life Outcomes. 2022 Jan 10;20(1):6. doi: 10.1186/s12955-021-01909-3. PMID 35012566
- DERIVEDLaudenslager ML, Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Brewer BW, Sannes TS, Kilbourn K, Gutman J, McSweeney P. A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Psychooncology. 2019 Aug;28(8):1614-1623. doi: 10.1002/pon.5126. Epub 2019 May 25. PMID 31127974