Clinical trial NCT04423848: Home Hospital for Lymphoma
Official title: Supportive Oncology Care at Home Intervention for Patients With Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphoma
Keywords: Lymphoma
Home Care Services, Hospital-Based
Cancer Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research is to evaluate an intervention, which the investigators call "Home Hospital for Lymphoma," that involves remote patient monitoring and home-based supportive care for patients hospitalized with lymphoma at Massachusetts General Hospital.

Detailed description: This research study is a single arm pilot Feasibility Study, which is the first-time investigators are examining this hospital at home intervention for patients with lymphoma.

The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms and home monitored vital signs) and home-based supportive care (e.g. visits to patients' homes to address and manage any concerning issues identified), and interviews of participants, caregivers, and clinicians asking their perceptions of the Home Hospital for Lymphoma program.

Participants will include 3 groups:

Enrolled participants receiving the hospital at home intervention, caregivers of participants, and clinicians.

Participants will be in the research study for about six months after consent. It is expected that up to 38 participants will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Receiving their lymphoma care with curative intent at MGH (treatment intent based upon chemotherapy order in the electronic medical record)
* Hemodynamically stable during the first 24 hours of hospital admission at MGH
* Residing within the designated geographic area for MGH Home Hospital Service (an approximately 10-mile radius from MGH)
* Able to communicate and respond to questionnaires in English
* Lives with a family member or a friend who supports the patient at home
* Deemed eligible for supportive oncology care at home based on the MGH Home Hospital clinician evaluation

Exclusion Criteria:

* Those admitted to the intensive care unit
* Have high oxygen requirement (FIO2 \> 0.4)
* Experience active angina or cardiac arrythmias
* Have a planned inpatient surgical or interventional procedure
* Have uncontrolled psychiatric illness or impaired cognition that prohibits complying with the study procedures
* Have uncontrolled pain requiring intravenous pain medications
* Those deemed ineligible based on the Home Hospital Service clinician evaluation

Primary outcomes:
measure: enrollment rate
timeFrame: 1 year
measure: retention rate
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: 1 year
measure: Rates of completion of daily vital signs
timeFrame: 1 year
measure: Rates of Adverse Events
timeFrame: 1 year
Other outcomes:
measure: Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
timeFrame: 1 year
measure: Psychological distress (Hospital Anxiety and Depression Scale - HADS)
timeFrame: 1 year
measure: Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
timeFrame: 1 year
measure: Length of home hospital admission
timeFrame: 1 year
measure: Number of home visits
timeFrame: 1 year
measure: Number of phone calls
timeFrame: 1 year
measure: Number of urgent visits
timeFrame: 1 year
measure: Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
timeFrame: 1 year
measure: Number of hospital readmissions
timeFrame: 1 year
measure: Number of imaging studies
timeFrame: 1 year
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: