Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-28 @ 7:48 PM
Study NCT ID:
NCT04637035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2020-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supportive Oncology Care at Home Post-Discharge
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: