Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
NCT Number: NCT04637035
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:
1. Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight); 2. 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); 3. Structured communication with the oncology team to ensure continuity of care.
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Notify MeThis 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.
Time frame: 2 years
Proportion of patients who agree to participate in the study and sign informed consent.
Time frame: 2 years
Proportion of daily patient-reported symptom assessments completed throughout the study period.
Time frame: 2 years
Proportion of daily vital signs completed throughout the study period.
Time frame: 2 years
Proportion of daily reporting body weights completed throughout the study period.
Time frame: Baseline to 2 weeks post-enrollment
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home.
Time frame: Baseline to 2 weeks post-enrollment
Average duration of home visits required during the study period.
Time frame: Baseline to 2 weeks post-enrollment
Issues addressed during home visit throughout the study period.
Time frame: Baseline to 2 weeks post-enrollment
Interventions delivered to patients at their home throughout the study period.
Time frame: Baseline to 2 weeks post-enrollment
Number of phone calls required per patient.
Time frame: Baseline to 2 weeks post-enrollment
Average duration of phone calls required for patients.
Time frame: Baseline to 2 weeks post-enrollment
Number of emails from Medically Home to the primary oncology team.
Time frame: 1 year
Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study.
Time frame: 1 year
Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study.
Time frame: 1 year
Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study.
Time frame: Baseline to 2 weeks post-enrollment
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.
Time frame: Baseline to 2 weeks post-enrollment
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.
Time frame: Baseline to 2 weeks post-enrollment
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.
Time frame: Baseline to 2 weeks post-enrollment
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.
Time frame: Baseline up to one month post-enrollment
The number of emergency department [ED] visits per patient.
Time frame: 1 year
Proportion of patients needing an emergency department [ED] visit.
Time frame: Baseline up to one month post-enrollment
The number of urgent visits to clinic per patient.
Time frame: 1 year
Proportion of patients needing an urgent visit to clinic.
Time frame: Baseline up to one month post-enrollment
The number of hospital readmissions per patient.
Time frame: 1 year
Proportion of patients needing hospital readmission.
Time frame: Baseline up to one month post-enrollment
The length of stay (LOS) per each hospital readmission for patients who are readmitted.
Time frame: Baseline to 2 weeks post-enrollment
The proportion of days patients spent outside the hospital during the study period.
Time frame: Baseline to 2 weeks post-enrollment
The index hospitalization length of stay (LOS).
Time frame: Baseline to 2 weeks post-enrollment
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.
Time frame: Baseline to 2 weeks post-enrollment
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.
Massachusetts General Hospital
Other
Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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