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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
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The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)
Frequently patients living with chronic GVHD experience physical and emotional symptoms during the course of illness that impacts their quality of life. Patients also often report difficulty managing many of the tasks they need to do to manage their chronic GVHD. They also frequently have a lot of questions about chronic GVHD and the expected trajectory of this illness.
The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, and psychological distress in patients with chronic GVHD
The Leukemia and Lymphoma Society is supporting this research by providing funding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Horizons mobile app | Experimental | Participants randomly assigned to the Horizons group, will use the Horizons app over an eight-week period in addition to receiving usual care from transplant team. Participants will complete study questionnaires at the time of enrollment (baseline) and at eight and sixteen weeks after enrollment |
|
| Usual Care | Active Comparator | Participant in the usual care group will receive usual care from the transplant oncology team including all the supportive care measures implemented by the transplant oncology team. Participants will complete study questionnaires at the time of enrollment (baseline) nad at eight and sixteen weeks after enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App | Behavioral | HORIZONS is self-administered with several features to promote engagement and health behavior change including gamification strategies, videos of chronic GVHD survivors, and optional content. HORIZONS includes five interactive modules to be completed during an eight week period. HORIZONS also includes a sixth optional helpful resources section with a review of the domains and skills covered in the first five modules |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) | Compare patient QOL (FACT-BMT) between usual care and Horizon at 8 weeks using ANCOVA. FACT-BMT score range 0-164, with higher scores indicating better quality of life. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QOL) longitudinal using FACT-BMT | Compare patient QOL (FACT-BMT) longitudinally between Horizons and usual care group using mixed linear effect models. FACT-BMT score range 0-164, with higher scores indicating better quality of life. | Up to sixteen weeks |
| Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy (PROMIS self-efficacy scale) | Compare self-efficacy (PROMIS-self-efficacy scale) between the study groups. The PROMIS self-efficacy for managing symptoms scale ranges from 0-100 with higher scores indicating better self-efficacy | up to sixteen weeks |
| patient coping using Measure of Current Status (MOCS) |
Inclusion Criteria:
Exclusion Criteria:
-Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | 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 |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Usual Care | Behavioral | Patients in the usual care group will receive usual care from the transplant oncology team including all the supportive care measures implemented by the transplant oncology team. |
|
Compare anxiety symptoms (HADS-Anxiety) between study groups. The HADS anxiety subscale range from 0-21 with higher scores indicating worse anxiety symptoms |
| up to sixteen weeks |
| Depression symptoms using HADS-Depression | Compare depression symptoms (HADS-depression) between study groups. The HADS depression subscale range from 0-21 with higher scores indicating worse depression symptoms | up to sixteen weeks |
| Chronic GVHD symptom burden (Lee Scale) | compare chronic GVHD symptom burden (Lee Scale) between the study groups. The Lee Scale ranges from 0-100 with higher scores indicating worse symptom burden | up to sixteen weeks |
Comparing coping (MOCS) between study groups (MOCS score range 0-52, with higher scores indicating greater coping skill). |
| up to sixteen weeks |
| social support using Medical Outcomes Study Social Support Survey (MOS SSS) | Compare patient social support (MOS SSS) between study groups. MOS SSS score range 0-100, with higher scores indicating greater support. | up to sixteen weeks |
| Usability of the Horizons app using the system usability scale | We will use the system usability scale at 8 weeks post-intervention (for those randomized to Horizons) to assess the usability of HORIZONS. the system usability scale score range from 0-100 with higher scores indicating better usability | eight weeks |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |