Hospital at Home at EOL in Heme Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: End of Life (EOL) Care at at Home

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:

1) 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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: End of Life (EOL) Care at at Home; 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.	Other: End of Life (EOL) Care at at Home; Remote monitoring and home-based care designed for patients with advanced hematologic malignancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	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	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.	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.	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	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	Up to 6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Medically Home
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 26, 2020
• First Submitted That Met QC Criteria: December 26, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 27, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hematologic Malignancy; Home Care Services
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 20-468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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: [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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No