Home Hospital for Lymphoma

Lymphoma Clinical Trial

Official title:

Supportive Oncology Care at Home Intervention for Patients With Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04423848
• Other study ID #: 19-613
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: October 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Other:
• Home Hospital for Lymphoma
Remote monitoring and home-based care designed for hospitalized patients with lymphoma

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)	Change in participants' symptom burden as measured by the ESAS-r throughout the study. The ESAS-r ranges 0-10 for each symptom with higher scores indicating worse symptom burden.	1 year
Other	Psychological distress (Hospital Anxiety and Depression Scale - HADS)	Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.	1 year
Other	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, with range of 0-108 and higher scores indicating better quality of life.	1 year
Other	Length of home hospital admission	Number of days the participant receives home hospital care through the home hospital program.	1 year
Other	Number of home visits	Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.	1 year
Other	Number of phone calls	Number of phone calls required per participants as well as the average duration of these calls.	1 year
Other	Number of urgent visits	The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.	1 year
Other	Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission	The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.	1 year
Other	Number of hospital readmissions	The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.	1 year
Other	Number of imaging studies	The number of imaging studies obtained per participant during the Home Hospital admission.	1 year
Primary	enrollment rate	The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study	1 year
Primary	retention rate	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.	1 year
Secondary	Acceptability of the intervention	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.	1 year
Secondary	Rates of completion of daily vital signs	Proportion of participants that complete daily reporting of vital signs during their home hospital admission.	1 year
Secondary	Rates of Adverse Events	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.	1 year