Skip to main content
OpenTrials
Completed

NCT Number: NCT04637035

Supportive Oncology Care at Home Post-Discharge

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive Oncology Care at Home

Other

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

Primary outcomes

  1. Rates of study enrollment

    Time frame: 2 years

    Proportion of patients who agree to participate in the study and sign informed consent.

  2. Rates of completion of daily symptom assessment

    Time frame: 2 years

    Proportion of daily patient-reported symptom assessments completed throughout the study period.

Secondary outcomes

  1. Rates of completion of daily vital signs

    Time frame: 2 years

    Proportion of daily vital signs completed throughout the study period.

  2. Rates of completion of daily body weight

    Time frame: 2 years

    Proportion of daily reporting body weights completed throughout the study period.

  3. Number of home visits required

    Time frame: Baseline to 2 weeks post-enrollment

    Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home.

  4. Duration of home visits

    Time frame: Baseline to 2 weeks post-enrollment

    Average duration of home visits required during the study period.

  5. Issues addressed during home visits

    Time frame: Baseline to 2 weeks post-enrollment

    Issues addressed during home visit throughout the study period.

  6. Interventions delivered during home visits

    Time frame: Baseline to 2 weeks post-enrollment

    Interventions delivered to patients at their home throughout the study period.

  7. Number of phone calls required

    Time frame: Baseline to 2 weeks post-enrollment

    Number of phone calls required per patient.

  8. Duration of phone calls

    Time frame: Baseline to 2 weeks post-enrollment

    Average duration of phone calls required for patients.

  9. Number of emails required

    Time frame: Baseline to 2 weeks post-enrollment

    Number of emails from Medically Home to the primary oncology team.

  10. Patient acceptability

    Time frame: 1 year

    Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study.

  11. Family caregiver acceptability

    Time frame: 1 year

    Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study.

  12. Clinician acceptability

    Time frame: 1 year

    Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study.

  13. Change in symptoms burden longitudinally throughout the study

    Time frame: Baseline to 2 weeks post-enrollment

    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.

  14. Change in psychological distress score longitudinally throughout the study

    Time frame: Baseline to 2 weeks post-enrollment

    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.

  15. Change in quality of life score longitudinally throughout the study

    Time frame: Baseline to 2 weeks post-enrollment

    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.

  16. Change in care satisfaction score longitudinally throughout the study

    Time frame: Baseline to 2 weeks post-enrollment

    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.

  17. Number of emergency department visits

    Time frame: Baseline up to one month post-enrollment

    The number of emergency department [ED] visits per patient.

  18. Rates of emergency department visits

    Time frame: 1 year

    Proportion of patients needing an emergency department [ED] visit.

  19. Number of urgent visits

    Time frame: Baseline up to one month post-enrollment

    The number of urgent visits to clinic per patient.

  20. Rates of urgent visits

    Time frame: 1 year

    Proportion of patients needing an urgent visit to clinic.

  21. Number of hospital readmissions

    Time frame: Baseline up to one month post-enrollment

    The number of hospital readmissions per patient.

  22. Rates of hospital readmissions

    Time frame: 1 year

    Proportion of patients needing hospital readmission.

  23. Length of hospital readmissions

    Time frame: Baseline up to one month post-enrollment

    The length of stay (LOS) per each hospital readmission for patients who are readmitted.

  24. Days outside of hospital

    Time frame: Baseline to 2 weeks post-enrollment

    The proportion of days patients spent outside the hospital during the study period.

  25. Hospitalization length of stay

    Time frame: Baseline to 2 weeks post-enrollment

    The index hospitalization length of stay (LOS).

  26. Change in caregivers reports of patients' symptom burden longitudinally throughout the study

    Time frame: Baseline to 2 weeks post-enrollment

    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.

  27. Concordance between caregiver and patient reports of patient symptom burden

    Time frame: Baseline to 2 weeks post-enrollment

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Medically Home Group, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2020
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.