Clinical trial NCT06472089: BMT-CARE: Psychosocial Intervention for Transplant Caregivers
Official title: Multimodal Psychosocial Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Marrow Transplant Complications
Hematologic Malignancy
Keywords: Neoplasms by Site
Hematologic Diseases
Neoplasms
Hematologic Neoplasms
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-06-24
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
timeFrame: Up to 60 days post-HCT
Secondary outcomes:
measure: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
timeFrame: Up to 180 days post-HCT
measure: Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire
timeFrame: Up to 180 days post-HCT
measure: Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale
timeFrame: Up to 180 days post-HCT
measure: Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale
timeFrame: Up to 180 days post-HCT
measure: Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire
timeFrame: Up to 180 days post HCT
measure: Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire
timeFrame: Up to 180 days post-HCT
Other outcomes:
measure: Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
timeFrame: Up to 180 days post-HCT
measure: Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale
timeFrame: Up to 180 days post-HCT
measure: Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale
timeFrame: Up to 180 days post-HCT
measure: Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r)
timeFrame: Up to 60 days post-HCT
measure: Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5)
timeFrame: Up to 180 days post HCT
measure: Rate of caregiver healthcare utilization as self-reported by caregivers
timeFrame: At 180 days post HCT
measure: Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers
timeFrame: At 180 days post HCT
measure: Rates of caregiver mental health resources utilization as self-reported by caregivers
timeFrame: At day 180 post HCT
measure: Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record
timeFrame: At 180 days post HCT
measure: Rates of patient mental health resources utilization as self-reported by patients
timeFrame: At day 180 post HCT
measure: Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record
timeFrame: At day 180 post HCT
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Brimingham
state: Alabama
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Jamie Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References: