Bone Marrow Transplant Complications, Hematologic Malignancy
Conditions
Keywords
Neoplasms by Site, Hematologic Diseases, Neoplasms, Hematologic Neoplasms
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.
Interventions
BEHAVIORALBMT-CARE
Therapist-delivered psychosocial intervention comprised of 6 sessions
BEHAVIORALUsual Care
Meeting a transplant social worker prior to HCT and as needed for extra visits
Sponsors
National Institutes of Health (NIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire | 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 |
| Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale | 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 |
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | 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 |
| Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire | 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 |
| Caregiver self-efficacy as measured by the Cancer Self-Efficacy-transplant (CASE-t) questionnaire | 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 |
| Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of caregiver mental health resources utilization as self-reported by caregivers | At day 180 post HCT | Compare rates of caregiver mental health resource utilization between study groups |
| Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record | At 180 days post HCT | Compare rates of patient healthcare utilization (eg., hospitalizations, emergency department visits) between the study groups. |
| Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire | 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 |
| Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record | At day 180 post HCT | Compare the rates of acute and/or chronic graft-versus-host disease between study groups |
| Rates of patient mental health resources utilization as self-reported by patients | At day 180 post HCT | Compare rates of patient mental health resource utilization between study groups |
| Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale | 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 |
| Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale | 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 |
| Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r) | 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. |
| Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5) | 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. |
| Rate of caregiver healthcare utilization as self-reported by caregivers | At 180 days post HCT | Compare Rates of caregiver healthcare utilization (e.g., hospitalizations, emergency department visits) between study groups. |
| Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers | At 180 days post HCT | Compare rates of caregiver adherence to primary care visits and age-appropriate cancer screening between study groups |
Countries
United States
Contacts
Primary ContactAreej El-Jawahri, MD
Backup ContactJamie Jacobs, PhD
Outcome results
None listed