Supportive Oncology Care at Home Post-Discharge

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Supportive Oncology Care at Home

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Medically Home Group, Inc.
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Remote Monitoring; Home Care
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 20-414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No