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NCT06472089 | RECRUITING | Bone Marrow Transplant Complications

BMT-CARE: Psychosocial Intervention for Transplant Caregivers
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Al -Jawahiri, Areej, M.

Brief Summary:

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.

Condition or disease

Bone Marrow Transplant Complications

Hematologic Malignancy

Intervention/treatment

BMT-CARE

Usual Care

Phase

NA

Detailed Description:

This is a randomized clinical trial to determine whether a psychosocial intervention (BMT-CARE) is effective at improving the quality of life and reducing psychosocial distress of caregivers and patients treated with hematopoietic cell transplant (HCT). The BMT-CARE intervention was developed with the goal of improving the experience and needs of caregivers of patients treated with HCT. Caregivers will be randomized into one of the two study groups: BMT-CARE plus usual care, or usual care. Participation in this study is expected to last up to 180 days after HCT. Investigators expect that about 400 caregivers and up to 400 patients treated with HCT will take part in this research study. The National Institutes of Health is supporting this research by providing funding.

Study Type : INTERVENTIONAL
Estimated Enrollment : 800 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Actual Study Start Date : 2025-01-10
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2029-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Caregiver Inclusion Criteria
  • * Adult caregivers (≥18 years) who is a relative or friend whom the patient identified as living with them or having in-person contact with them at least twice a week.
  • * Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer.
  • * Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter.
  • Caregiver Exclusion Criteria
    • * Caregivers of patients undergoing HCT for a benign hematologic condition or undergoing outpatient HCT.
    • * Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
    • Patient Inclusion Criteria
      • * Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT.
      • * Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter.
BMT-CARE: Psychosocial Intervention for Transplant Caregivers

Location Details

NCT06472089

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Brimingham

Birmingham, Albama, United States, 35294

NOT YET RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114