Bone Marrow Transplant ComplicationsBMT-CARENCT06472089
BMT-CARE: Psychosocial Intervention for Transplant Caregivers
A study testing BMT-CARE in people with Bone Marrow Transplant Complications and Hematologic Malignancy, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplant Complications, Hematologic Malignancy
- What is being tested?
- BMT-CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jan 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Alabama at Brimingham
Birmingham, Alabama, 35294
James Dionne-Odom, 205-934-7597, dionneod@uab.edu
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Areej El-Jawahri, MD, 617-643-4003, AEL-JAWAHRI@PARTNERS.ORG
Areej El-Jawahri, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Heather Jim, 813-745-6369, heather.jim@moffitt.org
About this study
Official title: Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Being tested
- BMT-CARE, Usual Care
- Keywords
- Neoplasms by Site, Hematologic Diseases, Neoplasms, Hematologic Neoplasms
- Medical subject headings
- Hematologic Neoplasms, Neoplasms by Site, Hematologic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT-CAREBehavioural
Therapist-delivered psychosocial intervention comprised of 6 sessions
Usual CareBehavioural
Meeting a transplant social worker prior to HCT and as needed for extra visits
| Study group | Role | What they receive |
|---|---|---|
| BMT-CARE | Experimental | 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. Receives: Behavioral: BMT-CARE |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 60 days post-HCT
Secondary outcomes (6)
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
Measured: Up to 180 days post-HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire
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
Measured: Up to 180 days post-HCT
Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale
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
Measured: Up to 180 days post-HCT
Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale
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
Measured: Up to 180 days post-HCT
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire
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
Measured: Up to 180 days post HCT
Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire
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
Measured: Up to 180 days post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start10 Jan 2025
- Primary completionMay 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General HospitalJamie Jacobs, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472089
- Sponsor's protocol ID
- 24-013
- Acronym
- BMT-CARE
- Status last verified
- Oct 2025
- First submitted
- 9 Jun 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06472089
- Acronym / sponsor ID
- BMT-CARE / 24-013
- Keywords
- Neoplasms by Site, Hematologic Diseases, Neoplasms, Hematologic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMT-CARE | Experimental | Behavioral: BMT-CAREParticipants 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. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT-CARETherapist-delivered psychosocial intervention comprised of 6 sessions | Behavioural | BMT-CARE |
| Usual CareMeeting a transplant social worker prior to HCT and as needed for extra visits | Behavioural | Usual Care |
Primary outcome
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
6 secondary outcomes
Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
Time frame: Up to 180 days post-HCT
Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire
Time frame: Up to 180 days post-HCT
Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale
Time frame: Up to 180 days post-HCT
Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale
Time frame: Up to 180 days post-HCT
Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire
Time frame: Up to 180 days post HCT
Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire
Time frame: Up to 180 days post-HCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
Jamie Jacobs, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT-CARE in people with Bone Marrow Transplant Complications and Hematologic Malignancy, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areej El-Jawahri, MD (617-721-4000, ael-jawahri@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.