Clinical trial NCT04690205: Hospital at Home at EOL in Heme Malignancies
Official title: Hospital-at-Home Care Model to Optimize End-of-Life (EOL) Care for Patients With Hematologic Malignancies: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Hematologic Malignancy
Home Care Services
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medically Home
First posted: 2020-12-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment Rate
timeFrame: 6 months
measure: Retention Rate
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: 6 months
measure: Patient Quality of Life (Functional Assessment of Cancer Therapy-General - Fact-G)
timeFrame: up to 6 months
measure: Caregiver Quality of Life (CareGiver Oncology QOL)
timeFrame: 6 months
measure: Patient Symptom Burden (using the Edmonton Symptom Assessment Scale-revise)
timeFrame: up to 6 months
measure: Caregiver Burden
timeFrame: up to 6 months
measure: Health Care Utilization
timeFrame: 6 months
measure: Patient psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
timeFrame: Up to 6 months
measure: Caregiver psychological distress (using the Hospital Anxiety and Depression Scale (HADS))
timeFrame: Up to 6 months
measure: Caregiver Satisfaction with patient's end of life (EOL) care using the FAMCARE
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, 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.