An interventional study of CARE Application and Usual Care in Bone Marrow Transplant Complications and Hematologic Malignancy, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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).
This is a randomized clinical trial to determine whether a 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). The CARE app was developed with the goal of addressing the needs of caregivers of HCT recipients.
Participants will be randomized into one of two study groups: CARE app plus Usual Care versus Usual Care.
Participation in this study is expected to last up to 100 days after HCT.
It is expected that about 120 people will take part in this research study.
The Leukemia and Lymphoma Society is supporting this research by providing funding.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Caregiver Inclusion Criteria:
Patient Exclusion Criteria:
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
Behavioral: CARE Application
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.
Behavioral: Usual Care
Self-administered, psychosocial mobile application comprised of 5 learning modules.
Meeting with transplant social worker prior to HCT, consistent with standard-of-care.
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Time frame: up to 60 days post-HCT
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Compare caregiver QOL as measured by the CARGOQOL between the two study groups longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL
Time frame: up to 100 days post HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)
Compare caregiving burden as measured by the CRA between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden
Time frame: Up to 100 days post HCT
Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)
Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms
Time frame: Up to 100 days post HCT
Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms
Time frame: Up to 100 days post HCT
Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist
Compare post-traumatic stress symptoms as measured by the Post-Traumatic Stress Checklist-Civilian Version between the two groups. The checklist ranges from 17-85 with higher scores indicating worse PTSD Symptoms
Time frame: Up to 100 days post HCT
Coping as measured by the Measure of Current Status (MOCS)
Comparing caregiver coping as measured by the MOCS between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills
Time frame: Up to 100 days post-HCT
Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale
Compare caregiver self-efficacy as measured by the CASE-t between the two study groups. The scale ranges from 0-170 with higher scores indicating better self-efficacy
Time frame: Up to 100 days post-HCT
Usability of the CARE app using the System Usability Scale
Assess the usability of the care app (in those receiving the intervention) using the System Usability Scale, which ranges 0-100 with higher scores indicating better usability
Time frame: up to 60 days post-HCT
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap, Icf
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital