BMT-CARE: Psychosocial Intervention for Transplant Caregivers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Massachusetts General Hospital
Study ID
NCT06472089
Status
Recruiting
Apply to this trial

Conditions

  • Bone Marrow Transplant Complications
  • Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMT-CARE — BEHAVIORAL
    Therapist-delivered psychosocial intervention comprised of 6 sessions
  • Usual Care — BEHAVIORAL
    Meeting a transplant social worker prior to HCT and as needed for extra visits

Study Details

The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.

Key Dates

Start date
Jan 10, 2025
Status verified
Oct 2025
Primary completion
May 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: BMT-CARE
    Participants randomized to BMT-CARE plus usual care will complete the following: * Questionnaires at baseline, and days 60, 90 and 180 post HCT. * Receive the BMT-CARE intervention from enrollment up to 60 days post-HCT. BMT-CARE is a -6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that integrates HCT-related education with CBT strategies to enhance caregiver knowledge and skills. * Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.
  • Active Comparator: Usual Care
    Participants randomized to usual care will complete the following * Questionnaires at baseline, and days 60, 90 and 180 post HCT. * Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.

Primary Outcome Measure

Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire [ Time Frame: Up to 60 days post-HCT ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BriminghamBirminghamAlabama35294
James Dionne-Odom
[email protected]
205-934-7597
Moffitt Cancer CenterTampaFlorida33612
Heather Jim
[email protected]
813-745-6369
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Areej El-Jawahri, MD
[email protected]
617-643-4003
Areej El-Jawahri, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Brimingham· Birmingham, ALMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital Cancer Center· Boston, MA

Related Studies