Supportive Oncology Care at Home Post-Discharge

NCT ID: NCT04637035

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2025-12-31

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. 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.

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Supportive Oncology Care at Home

Intervention Type: OTHER

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

Interventions

Supportive Oncology Care at Home

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medically Home Group, Inc.

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ryan Nipp

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan D Nipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35397575 (View on PubMed)

Other Identifiers

20-414

Identifier Type: -

Identifier Source: org_study_id