Supportive Oncology Care at Home Post-Discharge

Study Overview
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Brief Summary
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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: Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight); A Medically Home care model for symptom assessment, evaluation, and management (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified); Structured communication with the oncology team to ensure continuity of care.

Detailed Description
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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: Remote monitoring of symptoms, vital signs, and body weight Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and participant experience with cancer (e.g. your quality of life, your symptoms) Interviews to assess participant impressions of the program Caregiver Interviews, Questionnaires and Surveys to assess caregiver impressions of the program and caregiver perceptions of participant symptoms while in the program Clinician Interviews and Questionnaires to assess impressions of the program Data collection from participant medical record. 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.

Official Title
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Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Other: Supportive Oncology Care at Home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient Eligibility Age 18 or older Diagnosed with advanced cancer (defined as receiving treatment with palliative intent per chemotherapy order entry treatment intent designation and/or trial consent forms OR based on documentation in the oncology clinic notes for those not receiving chemotherapy) Admitted with an unplanned or non-elective hospitalization at Massachusetts General Hospital (MGH) Not requiring ICU-level care during their hospitalization Receiving care at the MGH Cancer Center Ability to read and respond to question in English Residing within 50 miles of MGH. Caregiver Eligibility Relative or friend of eligible patient Verbally fluent in English Age 18 or older 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 Are admitted to the intensive care unit Have a high oxygen requirement (FIO2 > 0.40) Experience active angina or cardiac arrythmias Have a planned inpatient surgical or interventional procedure Have uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent Are deemed ineligible for home-based care based on the inpatient oncology clinician assessment Are planning to be discharged to hospice or to any location other than their home 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Oncology Care at Home<br>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: Daily monitoring of patient-reported symptoms, vital signs, and body weight. Medically Home care based on algorithmic changes in patients' daily symptoms, vital signs, and body weight. Structured communication with the oncology team regarding care delivered to ensure continuity of care. | Other: Supportive Oncology Care at Home<br>* Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Home Care, Remote Monitoring