Supportive Oncology Care at Home Post-Discharge

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04637035
• Other study ID #: 20-414
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Supportive Oncology Care at Home
Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Medically Home Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of study enrollment	Proportion of patients who agree to participate in the study and sign informed consent.	2 years
Primary	Rates of completion of daily symptom assessment	Proportion of daily patient-reported symptom assessments completed throughout the study period.	2 years
Secondary	Rates of completion of daily vital signs	Proportion of daily vital signs completed throughout the study period.	2 years
Secondary	Rates of completion of daily body weight	Proportion of daily reporting body weights completed throughout the study period.	2 years
Secondary	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
Secondary	Duration of home visits	Average duration of home visits required during the study period.	Baseline to 2 weeks post-enrollment
Secondary	Issues addressed during home visits	Issues addressed during home visit throughout the study period.	Baseline to 2 weeks post-enrollment
Secondary	Interventions delivered during home visits	Interventions delivered to patients at their home throughout the study period.	Baseline to 2 weeks post-enrollment
Secondary	Number of phone calls required	Number of phone calls required per patient.	Baseline to 2 weeks post-enrollment
Secondary	Duration of phone calls	Average duration of phone calls required for patients.	Baseline to 2 weeks post-enrollment
Secondary	Number of emails required	Number of emails from Medically Home to the primary oncology team.	Baseline to 2 weeks post-enrollment
Secondary	Patient acceptability	Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study.	1 year
Secondary	Family caregiver acceptability	Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study.	1 year
Secondary	Clinician acceptability	Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of emergency department visits	The number of emergency department [ED] visits per patient.	Baseline up to one month post-enrollment
Secondary	Rates of emergency department visits	Proportion of patients needing an emergency department [ED] visit.	1 year
Secondary	Number of urgent visits	The number of urgent visits to clinic per patient.	Baseline up to one month post-enrollment
Secondary	Rates of urgent visits	Proportion of patients needing an urgent visit to clinic.	1 year
Secondary	Number of hospital readmissions	The number of hospital readmissions per patient.	Baseline up to one month post-enrollment
Secondary	Rates of hospital readmissions	Proportion of patients needing hospital readmission.	1 year
Secondary	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
Secondary	Days outside of hospital	The proportion of days patients spent outside the hospital during the study period.	Baseline to 2 weeks post-enrollment
Secondary	Hospitalization length of stay	The index hospitalization length of stay (LOS).	Baseline to 2 weeks post-enrollment
Secondary	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
Secondary	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