Clinical trial NCT04637035: Supportive Oncology Care at Home Post-Discharge
Official title: Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Home Care
Remote Monitoring
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medically Home Group, Inc.
First posted: 2020-11-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Rates of study enrollment
timeFrame: 2 years
measure: Rates of completion of daily symptom assessment
timeFrame: 2 years
Secondary outcomes:
measure: Rates of completion of daily vital signs
timeFrame: 2 years
measure: Rates of completion of daily body weight
timeFrame: 2 years
measure: Number of home visits required
timeFrame: Baseline to 2 weeks post-enrollment
measure: Duration of home visits
timeFrame: Baseline to 2 weeks post-enrollment
measure: Issues addressed during home visits
timeFrame: Baseline to 2 weeks post-enrollment
measure: Interventions delivered during home visits
timeFrame: Baseline to 2 weeks post-enrollment
measure: Number of phone calls required
timeFrame: Baseline to 2 weeks post-enrollment
measure: Duration of phone calls
timeFrame: Baseline to 2 weeks post-enrollment
measure: Number of emails required
timeFrame: Baseline to 2 weeks post-enrollment
measure: Patient acceptability
timeFrame: 1 year
measure: Family caregiver acceptability
timeFrame: 1 year
measure: Clinician acceptability
timeFrame: 1 year
measure: Change in symptoms burden longitudinally throughout the study
timeFrame: Baseline to 2 weeks post-enrollment
measure: Change in psychological distress score longitudinally throughout the study
timeFrame: Baseline to 2 weeks post-enrollment
measure: Change in quality of life score longitudinally throughout the study
timeFrame: Baseline to 2 weeks post-enrollment
measure: Change in care satisfaction score longitudinally throughout the study
timeFrame: Baseline to 2 weeks post-enrollment
measure: Number of emergency department visits
timeFrame: Baseline up to one month post-enrollment
measure: Rates of emergency department visits
timeFrame: 1 year
measure: Number of urgent visits
timeFrame: Baseline up to one month post-enrollment
measure: Rates of urgent visits
timeFrame: 1 year
measure: Number of hospital readmissions
timeFrame: Baseline up to one month post-enrollment
measure: Rates of hospital readmissions
timeFrame: 1 year
measure: Length of hospital readmissions
timeFrame: Baseline up to one month post-enrollment
measure: Days outside of hospital
timeFrame: Baseline to 2 weeks post-enrollment
measure: Hospitalization length of stay
timeFrame: Baseline to 2 weeks post-enrollment
measure: Change in caregivers reports of patients' symptom burden longitudinally throughout the study
timeFrame: Baseline to 2 weeks post-enrollment
measure: Concordance between caregiver and patient reports of patient symptom burden
timeFrame: Baseline to 2 weeks post-enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan D Nipp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.