Clinical trial · Interventional
Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)
NCT05709912CI-TRIAL-00097345active not recruitingN/AClinicalTrials.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)
The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Transplant Complications | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CARE Application | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CARE App
- description
- Participants randomized to the CARE app + usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100 post-HCT * use the CARE app from enrollment up to 60 days post-HCT: the CARE app includes 5 contains 5 modules and a 6th optional module * receive usual care as per HCT practice which entails meeting with a transplant social worker prior to HCT and as needed for extra visits
- interventionNames
- Behavioral: CARE Application
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Participants randomized to usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100. * receive usual care as per HCT practice, which entails meeting with a transplant social worker prior to HCT and as needed for extra visits.
- interventionNames
- Behavioral: Usual Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Caregiver Inclusion Criteria: * Adult caregivers (\>18 years) who is a relative or friend who live with the patient or is a designated caregiver as indicated during the transplant process. * Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer * Ability to comprehend and speak English as the CARE app is only available in English Patient Exclusion Criteria: * Caregivers of patients undergoing HCT for benign hematologic conditions * Caregivers with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
References
Publications (1)
- DERIVEDWillis KD, Barata A, Freese M, Applebaum AJ, Nelson A, Traeger LN, Horick NK, Rabideau DJ, Temel JS, Greer JA, Jacobs JM, El-Jawahri A. Randomised controlled trial of a psychosocial digital health application to promote coping for caregivers of patients undergoing haematopoietic stem cell transplantation: a study protocol for the BMT-CARE app. BMJ Open. 2025 Apr 8;15(4):e092371. doi: 10.1136/bmjopen-2024-092371. PMID 40204300