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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMT-CARE | Experimental | Participants randomized to BMT-CARE plus usual care will complete the following:
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| Usual Care | Active Comparator | Participants randomized to usual care will complete the following
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMT-CARE | Behavioral | Therapist-delivered psychosocial intervention comprised of 6 sessions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 60 days post-HCT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 180 days post-HCT |
| Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire | Compare patient QOL as measured by the FACT-BMT between the two study groups. Score range 0-196 and higher scores indicate better QOL | Up to 180 days post-HCT |
| Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale |
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
Patient Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Areej El-Jawahri, MD | Contact | 617-721-4000 | ael-jawahri@mgb.org | |
| Jamie Jacobs, PhD | Contact | 617-724-4000 | jjacobs@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Jamie Jacobs, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Brimingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| Usual Care |
| Behavioral |
Meeting a transplant social worker prior to HCT and as needed for extra visits |
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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 |
| 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 | 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 | 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 | 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 | 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 |
| Up to 180 days post-HCT |
| Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale | 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 | Up to 180 days post-HCT |
| Patient symptom burden as measured by the Revised Edmonton Symptom Assessment Scale -Revised (ESAS-r) | 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. | Up to 60 days post-HCT |
| Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5) | Compare patient medication adherence as measured by the MARS-5 between study groups. Score range 5-25 with higher scors indicating better adherence. | Up to 180 days post HCT |
| Rate of caregiver healthcare utilization as self-reported by caregivers | Compare Rates of caregiver healthcare utilization (e.g., hospitalizations, emergency department visits) between study groups. | At 180 days post HCT |
| Rate of caregiver adherence to primary care visits and age-appropriate cancer screening as self-reported by caregivers | Compare rates of caregiver adherence to primary care visits and age-appropriate cancer screening between study groups | At 180 days post HCT |
| Rates of caregiver mental health resources utilization as self-reported by caregivers | Compare rates of caregiver mental health resource utilization between study groups | At day 180 post HCT |
| Rate of patient healthcare utilization as self-reported by patients and extracted from the electronic medical record | Compare rates of patient healthcare utilization (eg., hospitalizations, emergency department visits) between the study groups. | At 180 days post HCT |
| Rates of patient mental health resources utilization as self-reported by patients | Compare rates of patient mental health resource utilization between study groups | At day 180 post HCT |
| Rates of acute and/or chronic graft-versus host disease based on data gathered from the electronic medical record | Compare the rates of acute and/or chronic graft-versus-host disease between study groups | At day 180 post HCT |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02114 | United States |
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