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NCT Number: NCT06472089

BMT-CARE: Psychosocial Intervention for Transplant Caregivers

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.

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Key information

Conditions

Bone Marrow Transplant Complications Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Brimingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Caregiver Inclusion Criteria:

  • Adult caregivers (≥18 years) relative or friend of a 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.
  • Caregivers of patients who have already undergone HCT within the past 5 years

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.

Treatment and study plan

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

Primary outcomes

  1. Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire

    Time frame: Up to 60 days post-HCT

    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

Secondary outcomes

  1. Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire

    Time frame: Up to 180 days post-HCT

    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

  2. Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire

    Time frame: Up to 180 days post-HCT

    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

  3. Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale

    Time frame: Up to 180 days post-HCT

    Compare caregiver 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

  4. Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale

    Time frame: Up to 180 days post-HCT

    Compare caregiver 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

  5. Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire

    Time frame: Up to 180 days post HCT

    Compare caregiver coping as measured by the MOCS-A between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills

  6. Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire

    Time frame: Up to 180 days post-HCT

    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

Other outcomes

  1. Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

    Time frame: Up to 180 days post-HCT

    Compare patient QOL as measured by the FACT-BMT between the two study groups. Score range 0-196 and higher scores indicate better QOL

  2. Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale

    Time frame: Up to 180 days post-HCT

    Compare patient 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

  3. Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale

    Time frame: Up to 180 days post-HCT

    Compare patient 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

  4. Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r)

    Time frame: Up to 60 days post-HCT

    Compare patient symptom burden as measured by the ESAS-r between the study groups. Scor range 0-100 and higher scores indicate worse symptom burden.

  5. Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5)

    Time frame: Up to 180 days post HCT

    Compare patient medication adherence as measured by the MARS-5 between study groups. Score range 5-25 with higher scors indicating better adherence.

  6. Rate of caregiver healthcare utilization as self-reported by caregivers

    Time frame: At 180 days post HCT

    Compare Rates of caregiver healthcare utilization (e.g., hospitalizations, emergency department visits) between study groups.

  7. Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers

    Time frame: At 180 days post HCT

    Compare rates of caregiver adherence to primary care visits and age-appropriate cancer screening between study groups

  8. Rates of caregiver mental health resources utilization as self-reported by caregivers

    Time frame: At day 180 post HCT

    Compare rates of caregiver mental health resource utilization between study groups

  9. Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record

    Time frame: At 180 days post HCT

    Compare rates of patient healthcare utilization (eg., hospitalizations, emergency department visits) between the study groups.

  10. Rates of patient mental health resources utilization as self-reported by patients

    Time frame: At day 180 post HCT

    Compare rates of patient mental health resource utilization between study groups

  11. Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record

    Time frame: At day 180 post HCT

    Compare the rates of acute and/or chronic graft-versus-host disease between study groups

Study contacts

Contact information is provided by the study sponsor or research team.

Areej El-Jawahri, MD

CONTACT

[email protected]

617-721-4000

Jamie Jacobs, PhD

CONTACT

[email protected]

617-724-4000

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation

Acronym: BMT-CARE

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 24, 2024
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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