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Clinical Trials/NCT04423848
NCT04423848
Terminated
Not Applicable

Supportive Oncology Care at Home Intervention for Patients With Lymphoma

Massachusetts General Hospital1 site in 1 country3 target enrollmentJune 1, 2020
ConditionsLymphoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphoma
Sponsor
Massachusetts General Hospital
Enrollment
3
Locations
1
Primary Endpoint
enrollment rate
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
January 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

El-Jawahri, Areej,M.D.

Principal Investigator

Massachusetts General Hospital

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

Outcomes

Primary Outcomes

enrollment rate

Time Frame: 1 year

The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study

retention rate

Time Frame: 1 year

The primary endpoint is feasibility. The proposed intervention will be deemed feasible if those enrolled patients complete at least 60% of daily patient-reported symptom assessment.

Secondary Outcomes

  • Rates of completion of daily vital signs(1 year)
  • Acceptability of the intervention(1 year)
  • Rates of Adverse Events(1 year)

Study Sites (1)

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