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| Name | Class |
|---|---|
| Medically Home Group, Inc. | UNKNOWN |
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This study is evaluating if a program that involves remote monitoring and home-based care may improve the post-discharge care of recently hospitalized patients with advanced cancer.
The Supportive Oncology Care at Home intervention consists of three key components:
This is a single-arm pilot study of recently hospitalized patients with advanced cancer to assess the the feasibility of delivering a remote monitoring and home-based program, Supportive Oncology Care at Home, the acceptability and satisfaction with the Supportive Oncology Care at Home program, and changes in the quality of life and symptoms of patients who receive the Supportive Oncology Care at Home program.
Oncologists at the MGH Cancer Center developed the Supportive Oncology Care program to address the symptoms and frequent hospital visits that patients face as a result of their cancer and the treatment they receive.
The research study procedures include:
Patients will take part in the program for two weeks following hospital discharge.
It is expected that between 75 and 110 people will enroll, including up to 30 patients, up to 30 caregivers, and up to 15 clinicians.
Medically Home Group, Inc. is supporting this research study by providing funding for this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Oncology Care at Home | Experimental | Participants will receive the Supportive Oncology Care at Home program for 14 days following their discharge from the hospital. The Supportive Oncology Care at Home intervention consists of three key components:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Oncology Care at Home | Other | Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of study enrollment | Proportion of patients who agree to participate in the study and sign informed consent. | 2 years |
| Rates of completion of daily symptom assessment | Proportion of daily patient-reported symptom assessments completed throughout the study period. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of completion of daily vital signs | Proportion of daily vital signs completed throughout the study period. | 2 years |
| Rates of completion of daily body weight | Proportion of daily reporting body weights completed throughout the study period. |
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Inclusion Criteria:
Patient Eligibility
Caregiver Eligibility
Clinician Eligibility
-- Outpatient oncology physicians and advanced practice clinicians who care for patients that receive the Supportive Oncology Care at Home intervention
Exclusion Criteria:
Patient Exclusion
Caregiver Exclusion -- Caregivers who are unwilling or unable to participate in the study.
Clinician Exclusion
-- Clinicians who are unwilling or unable to participate in the study.
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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 | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35397575 | Derived | Nipp RD, Shulman E, Smith M, Brown PMC, Johnson PC, Gaufberg E, Vyas C, Qian CL, Neckermann I, Hornstein SB, Reynolds MJ, Greer J, Temel JS, El-Jawahri A. Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer. BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z. |
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Description: 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 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 |
|---|---|
| D009369 | Neoplasms |
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| 2 years |
| Number of home visits required | Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home. | Baseline to 2 weeks post-enrollment |
| Duration of home visits | Average duration of home visits required during the study period. | Baseline to 2 weeks post-enrollment |
| Issues addressed during home visits | Issues addressed during home visit throughout the study period. | Baseline to 2 weeks post-enrollment |
| Interventions delivered during home visits | Interventions delivered to patients at their home throughout the study period. | Baseline to 2 weeks post-enrollment |
| Number of phone calls required | Number of phone calls required per patient. | Baseline to 2 weeks post-enrollment |
| Duration of phone calls | Average duration of phone calls required for patients. | Baseline to 2 weeks post-enrollment |
| Number of emails required | Number of emails from Medically Home to the primary oncology team. | Baseline to 2 weeks post-enrollment |
| Patient acceptability | Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study. | 1 year |
| Family caregiver acceptability | Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study. | 1 year |
| Clinician acceptability | Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study. | 1 year |
| Change in symptoms burden longitudinally throughout the study | Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher score indicating worse symptom burden) throughout the study. | Baseline to 2 weeks post-enrollment |
| Change in psychological distress score longitudinally throughout the study | Change in psychological distress (assessed using Hospital Anxiety and Depression Scale [HADS], range 0-21 for scores of anxiety and depression with higher score indicating worse anxiety or depression) throughout the study. | Baseline to 2 weeks post-enrollment |
| Change in quality of life score longitudinally throughout the study | Change in quality of life (assessed using Functional Assessment of Cancer Therapy-General [FACT-G] questionnaire, assessing physical, functional, emotional, and social well-being during the prior seven days, with total score ranging from 0-108 with higher scores indicating better quality of life) throughout the study. | Baseline to 2 weeks post-enrollment |
| Change in care satisfaction score longitudinally throughout the study | Change in patient care satisfaction (assessed using the 16-item FAMCARE questionnaire [FAMCARE-P], range of 16-80 with higher score indicating higher care satisfaction) throughout the study. | Baseline to 2 weeks post-enrollment |
| Number of emergency department visits | The number of emergency department [ED] visits per patient. | Baseline up to one month post-enrollment |
| Rates of emergency department visits | Proportion of patients needing an emergency department [ED] visit. | 1 year |
| Number of urgent visits | The number of urgent visits to clinic per patient. | Baseline up to one month post-enrollment |
| Rates of urgent visits | Proportion of patients needing an urgent visit to clinic. | 1 year |
| Number of hospital readmissions | The number of hospital readmissions per patient. | Baseline up to one month post-enrollment |
| Rates of hospital readmissions | Proportion of patients needing hospital readmission. | 1 year |
| Length of hospital readmissions | The length of stay (LOS) per each hospital readmission for patients who are readmitted. | Baseline up to one month post-enrollment |
| Days outside of hospital | The proportion of days patients spent outside the hospital during the study period. | Baseline to 2 weeks post-enrollment |
| Hospitalization length of stay | The index hospitalization length of stay (LOS). | Baseline to 2 weeks post-enrollment |
| Change in caregivers reports of patients' symptom burden longitudinally throughout the study | Change in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher score indicating worse symptom burden) throughout the study. | Baseline to 2 weeks post-enrollment |
| Concordance between caregiver and patient reports of patient symptom burden | Difference in symptom burden (assessed using Edmonton Symptom Assessment System-revised [ESAS-r], range 0-10 for each symptom with higher score indicating worse symptom burden) between patients and caregivers throughout the study. | Baseline to 2 weeks post-enrollment |