CancerNCT04637035
Supportive Oncology Care at Home Post-Discharge
A study testing Supportive Oncology Care at Home in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Supportive Oncology Care at Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
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:
- Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight);
- 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);
- Structured communication with the oncology team to ensure continuity of care.
Read the 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
- Being tested
- Supportive Oncology Care at Home
- Keywords
- Cancer, Home Care, Remote Monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Oncology Care at HomeOther
Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supportive Oncology Care at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of study enrollment
Proportion of patients who agree to participate in the study and sign informed consent.
Measured: 2 years
Rates of completion of daily symptom assessment
Proportion of daily patient-reported symptom assessments completed throughout the study period.
Measured: 2 years
Secondary outcomes (27)
Rates of completion of daily vital signs
Proportion of daily vital signs completed throughout the study period.
Measured: 2 years
Rates of completion of daily body weight
Proportion of daily reporting body weights completed throughout the study period.
Measured: 2 years
Number of home visits required
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to patients at their home.
Measured: Baseline to 2 weeks post-enrollment
Duration of home visits
Average duration of home visits required during the study period.
Measured: Baseline to 2 weeks post-enrollment
Issues addressed during home visits
Issues addressed during home visit throughout the study period.
Measured: Baseline to 2 weeks post-enrollment
Interventions delivered during home visits
Interventions delivered to patients at their home throughout the study period.
Measured: Baseline to 2 weeks post-enrollment
Number of phone calls required
Number of phone calls required per patient.
Measured: Baseline to 2 weeks post-enrollment
Duration of phone calls
Average duration of phone calls required for patients.
Measured: Baseline to 2 weeks post-enrollment
Number of emails required
Number of emails from Medically Home to the primary oncology team.
Measured: Baseline to 2 weeks post-enrollment
Patient acceptability
Qualitative interview acceptability ratings from patients regarding usefulness, effectiveness, and relevance of the study.
Measured: 1 year
Family caregiver acceptability
Qualitative interview acceptability ratings from caregivers regarding usefulness, effectiveness, and relevance of the study.
Measured: 1 year
Clinician acceptability
Qualitative interview acceptability ratings from clinicians regarding usefulness, effectiveness, and relevance of the study.
Measured: 1 year
Change in symptoms burden longitudinally throughout the study
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.
Measured: Baseline to 2 weeks post-enrollment
Change in psychological distress score longitudinally throughout the study
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.
Measured: Baseline to 2 weeks post-enrollment
Change in quality of life score longitudinally throughout the study
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.
Measured: Baseline to 2 weeks post-enrollment
Change in care satisfaction score longitudinally throughout the study
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.
Measured: Baseline to 2 weeks post-enrollment
Number of emergency department visits
The number of emergency department [ED] visits per patient.
Measured: Baseline up to one month post-enrollment
Rates of emergency department visits
Proportion of patients needing an emergency department [ED] visit.
Measured: 1 year
Number of urgent visits
The number of urgent visits to clinic per patient.
Measured: Baseline up to one month post-enrollment
Rates of urgent visits
Proportion of patients needing an urgent visit to clinic.
Measured: 1 year
Number of hospital readmissions
The number of hospital readmissions per patient.
Measured: Baseline up to one month post-enrollment
Rates of hospital readmissions
Proportion of patients needing hospital readmission.
Measured: 1 year
Length of hospital readmissions
The length of stay (LOS) per each hospital readmission for patients who are readmitted.
Measured: Baseline up to one month post-enrollment
Days outside of hospital
The proportion of days patients spent outside the hospital during the study period.
Measured: Baseline to 2 weeks post-enrollment
Hospitalization length of stay
The index hospitalization length of stay (LOS).
Measured: Baseline to 2 weeks post-enrollment
Change in caregivers reports of patients' symptom burden longitudinally throughout the study
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.
Measured: Baseline to 2 weeks post-enrollment
Concordance between caregiver and patient reports of patient symptom burden
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.
Measured: Baseline to 2 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start19 Aug 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medically Home Group, Inc.
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637035
- Sponsor's protocol ID
- 20-414
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
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.
PubMed 35397575
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering a Supportive Oncology Care at Home Intervention for Hospitalized Patients With Cancer
- ClinicalTrials.gov ID
- NCT04637035
- Acronym / sponsor ID
- 20-414
- Conditions
- Cancer
- Keywords
- Cancer, Home Care, Remote Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Medically Home Group, Inc.
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight);
- 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);
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Oncology Care at Home | Experimental | Other: Supportive Oncology Care at HomeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Oncology Care at HomeIntervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care. | Other | Supportive Oncology Care at Home |
Primary outcome
Rates of study enrollment
Time frame: 2 years
Proportion of patients who agree to participate in the study and sign informed consent.
Rates of completion of daily symptom assessment
Time frame: 2 years
Proportion of daily patient-reported symptom assessments completed throughout the study period.
27 secondary outcomes
Rates of completion of daily vital signs
Time frame: 2 years
Rates of completion of daily body weight
Time frame: 2 years
Number of home visits required
Time frame: Baseline to 2 weeks post-enrollment
Duration of home visits
Time frame: Baseline to 2 weeks post-enrollment
Issues addressed during home visits
Time frame: Baseline to 2 weeks post-enrollment
Interventions delivered during home visits
Time frame: Baseline to 2 weeks post-enrollment
Number of phone calls required
Time frame: Baseline to 2 weeks post-enrollment
Duration of phone calls
Time frame: Baseline to 2 weeks post-enrollment
Number of emails required
Time frame: Baseline to 2 weeks post-enrollment
Patient acceptability
Time frame: 1 year
Family caregiver acceptability
Time frame: 1 year
Clinician acceptability
Time frame: 1 year
Change in symptoms burden longitudinally throughout the study
Time frame: Baseline to 2 weeks post-enrollment
Change in psychological distress score longitudinally throughout the study
Time frame: Baseline to 2 weeks post-enrollment
Change in quality of life score longitudinally throughout the study
Time frame: Baseline to 2 weeks post-enrollment
Change in care satisfaction score longitudinally throughout the study
Time frame: Baseline to 2 weeks post-enrollment
Number of emergency department visits
Time frame: Baseline up to one month post-enrollment
Rates of emergency department visits
Time frame: 1 year
Number of urgent visits
Time frame: Baseline up to one month post-enrollment
Rates of urgent visits
Time frame: 1 year
Number of hospital readmissions
Time frame: Baseline up to one month post-enrollment
Rates of hospital readmissions
Time frame: 1 year
Length of hospital readmissions
Time frame: Baseline up to one month post-enrollment
Days outside of hospital
Time frame: Baseline to 2 weeks post-enrollment
Hospitalization length of stay
Time frame: Baseline to 2 weeks post-enrollment
Change in caregivers reports of patients' symptom burden longitudinally throughout the study
Time frame: Baseline to 2 weeks post-enrollment
Concordance between caregiver and patient reports of patient symptom burden
Time frame: Baseline to 2 weeks post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 35397575Nipp 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.
- Individual participant dataSharing planned: Yes. Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Oncology Care at Home in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of study enrollment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.