Hematologic MalignancyNCT04690205
Hospital at Home at EOL in Heme Malignancies
A study testing End of Life (EOL) Care at at Home in people with Hematologic Malignancy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- End of Life (EOL) Care at at Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 1 Jul 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
- age 18 or older
- diagnosed with relapsed or refractory hematologic malignancy
- must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
- deemed eligible to receive EOL care at home based on the primary oncologist's assessment
- Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
- residing within 50 miles of MGH. Of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate.
Who cannot join
- Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.
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: Hospital-at-Home Care Model to Optimize End-of-Life (EOL) Care for Patients With Hematologic Malignancies: A Pilot Feasibility Study
This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.
Read the detailed description
This research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies.
Participants will include 3 groups:
- Enrolled patients with advanced hematologic malignancies receiving the end of life (EOL) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients.
Participants will be in this research study for approximately six months after consent. It is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study.
Medically Home company is supporting this research study by providing funding.
- Conditions
- Hematologic Malignancy
- Being tested
- End of Life (EOL) Care at at Home
- Keywords
- Hematologic Malignancy, Home Care Services
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End of Life (EOL) Care at at HomeOther
Remote monitoring and home-based care designed for patients with advanced hematologic malignancies
| Study group | Role | What they receive |
|---|---|---|
| End of Life (EOL) Care at at Home | Experimental | End of Life (EOL) Care at at Home intervention entails the following: patient-reported symptoms and home monitored vital signs and body weight with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care. Receives: Other: End of Life (EOL) Care at at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% (95% confidence interval +/- 18%) of eligible patients are enrolled in the study.
Measured: 6 months
Retention Rate
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 80% of enrolled participants will complete a minimum of 60% of their daily assessments (i.e. patient-reported symptoms)
Measured: 6 months
Secondary outcomes (9)
Acceptability of the intervention
Qualitative acceptability ratings from patients, caregivers, and oncology clinicians defined by perceptions of usefulness, effectiveness, and relevance of the intervention obtained via interviews regarding acceptability from patients, family caregivers, and oncology clinicians.
Measured: 6 months
Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)
Change in quality of life as measured by the FACT-G throughout the study. FACT-G score ranges from 0 to 108 points with higher score indicating better quality of life
Measured: up to 6 months
Caregiver Quality of Life (CareGiver Oncology QOL)
Change in caregiver quality of life as measured by the CarGOQOL throughout the study. Caregiver Oncology QOL questionnaire ranges from 0 to 100 points with higher scores indicating better caregiver quality of life
Measured: 6 months
Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)
Change in patient symptom burden measured with Edmonton Symptom Assessment System-revised (ESAS-r). Scores range from 0-100 with higher scores indicate worse symptom burden.
Measured: up to 6 months
Caregiver Burden
Caregiving burden will be assessed using the Caregiver Reaction Assessment (CRA) caregiving burden. The CRA score ranges from 24-120, with higher score indicating higher caregiving burden
Measured: up to 6 months
Health Care Utilization
Electronic Health Records (EHR) will be used to assess patient health care utilization including hospitalizations, chemotherapy use, and emergency department visits at the end of life.
Measured: 6 months
Patient psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
The Hospital Anxiety and Depression Scale (HADS) will be used to assess patient psychological distress. The HADS score ranges from 0-21 with higher score indicating more psychological distress.
Measured: Up to 6 months
Caregiver psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
The Hospital Anxiety and Depression Scale (HADS) will be used to caregiver psychological distress. The HADS score range from 0-21 with higher scores indicating worse psychological distress
Measured: Up to 6 months
Caregiver Satisfaction with patient's end of life (EOL) care using the FAMCARE
Nine items from the FAMCARE will be used to assess caregivers' satisfaction with the quality of medical services provided to them and the patient at the end of life. FAMCARE provides rating of quality of death on a scale of 0-10, with higher scores indicating best possible death. FAMCARE also provides a total score ranges 0-24, with higher score indicating better satisfaction with EOL care
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start26 Feb 2021
- Primary completion1 Jul 2024
- Study completion1 Jul 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 Hematologic MalignancyStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medically Home
- 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
- NCT04690205
- Sponsor's protocol ID
- 20-468
- Status last verified
- Jul 2026
- First submitted
- 26 Dec 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: \[contact information for Sponsor Investigator or designee\]. 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-at-Home Care Model to Optimize End-of-Life (EOL) Care for Patients With Hematologic Malignancies: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04690205
- Acronym / sponsor ID
- 20-468
- Conditions
- Hematologic Malignancy
- Keywords
- Hematologic Malignancy, Home Care Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Medically Home
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Dec 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 an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.
Detailed description
This research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies.
The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies.
Participants will include 3 groups:
- Enrolled patients with advanced hematologic malignancies receiving the end of life (EOL) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients.
Participants will be in this research study for approximately six months after consent. It is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study.
Medically Home company is supporting this research study by providing funding.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End of Life (EOL) Care at at Home | Experimental | Other: End of Life (EOL) Care at at HomeEnd of Life (EOL) Care at at Home intervention entails the following: patient-reported symptoms and home monitored vital signs and body weight with appropriate triggers for phone calls and home visits, and regular communication with oncology clinicians regarding care delivered at home 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 (6 listed)
- age 18 or older
- diagnosed with relapsed or refractory hematologic malignancy
- must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
- deemed eligible to receive EOL care at home based on the primary oncologist's assessment
- Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
Key exclusion criteria (1 listed)
- Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.
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 |
|---|---|---|
| End of Life (EOL) Care at at HomeRemote monitoring and home-based care designed for patients with advanced hematologic malignancies | Other | End of Life (EOL) Care at at Home |
Primary outcome
Enrollment Rate
Time frame: 6 months
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% (95% confidence interval +/- 18%) of eligible patients are enrolled in the study.
Retention Rate
Time frame: 6 months
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 80% of enrolled participants will complete a minimum of 60% of their daily assessments (i.e. patient-reported symptoms)
9 secondary outcomes
Acceptability of the intervention
Time frame: 6 months
Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)
Time frame: up to 6 months
Caregiver Quality of Life (CareGiver Oncology QOL)
Time frame: 6 months
Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)
Time frame: up to 6 months
Caregiver Burden
Time frame: up to 6 months
Health Care Utilization
Time frame: 6 months
Patient psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
Time frame: Up to 6 months
Caregiver psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
Time frame: Up to 6 months
Caregiver Satisfaction with patient's end of life (EOL) care using the FAMCARE
Time frame: Up to 6 months
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 21 Jul 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. 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: [contact information for 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 End of Life (EOL) Care at at Home in people with Hematologic Malignancy, 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 6 inclusion and 1 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 21 Jul 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?
Enrollment Rate (time frame: 6 months). 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 NCT04690205, 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 21 Jul 2026.