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| Name | Class |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | OTHER |
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The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease.
Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care.
Participation in this study is expected to last up to 18 weeks after enrollment.
The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HORIZONS intervention | Experimental | Participants randomized to HORIZONS plus usual care will complete the following:
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| Minimally enhanced 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 |
|---|---|---|---|---|
| HORIZONS Intervention | Behavioral | Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life (QOL) 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. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient quality of life (QOL) 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. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL | Up to 18 weeks post enrollment |
| Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Traeger PhD | Contact | 304-284-3012 | ltraeger@miami.edu | |
| Areej El-Jawahri MD | Contact | 617-721-4000 | ael-jawahri@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | 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 Areej El-Jawahri (ael-jawahri@mgb.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov 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 |
|---|---|
| D006086 | Graft vs Host Disease |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D009371 | Neoplasms by Site |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Minimally enhanced usual care | Behavioral | Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations |
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Compare 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 18 weeks post enrollment |
| Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse depression symptoms. | Up to 18 weeks post enrollment |
| Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale | Compare chronic graft versus host disease symptoms as measured by the Lee Symptom Scale. The Lee Symptom Scale ranges from 0 -100 with higher scores indicating worse symptomatology | Up to 18 weeks post enrollment |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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