Supportive Oncology Care at Home Post-Discharge

NCT04637035 | Completed DMC

• 1 other identifier: 20-414
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 1.Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight);
2. 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. 3.Structured communication with the oncology team to ensure continuity of care.

Conditions

Cancer

Keywords

Cancer; Home Care; Remote Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• Rates of completion of daily vital signs

  2 years

• Rates of completion of daily body weight

  2 years

• Number of home visits required

  Baseline to 2 weeks post-enrollment

• Duration of home visits

  Baseline to 2 weeks post-enrollment

• Issues addressed during home visits

  Baseline to 2 weeks post-enrollment

Study Arms (1)

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: * 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

Interventions

Supportive Oncology Care at Home OTHER

Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.

Supportive Oncology Care at Home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \-- Clinicians who are unwilling or unable to participate in the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medically Home Group, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 35397575 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 19, 2020
• Study Start: August 19, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)