Home Hospital for Lymphoma

Not Applicable

Terminated

• Conditions: Lymphoma
• Interventions: Other: Home Hospital for Lymphoma

• Registration Number: NCT04423848
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home Hospital for Lymphoma	Home Hospital for Lymphoma	The Home Hospital for Lymphoma intervention entails the following: patient-reported symptoms and vital signs 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.

Primary Outcome Measures

Name	Time	Method
enrollment rate	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	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 Outcome Measures

Name	Time	Method
Rates of completion of daily vital signs	1 year	Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
Acceptability of the intervention	1 year	Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians. The intervention will be deemed acceptable if ≥ 60% of patients, family caregivers, and clinicians report that the intervention was helpful.
Rates of Adverse Events	1 year	The rates of Adverse Events and Serious Adverse Events that are judged by the treating lymphoma clinician to be at least possibly related to the study intervention.

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States