Home Hospital for Lymphoma

Supportive Oncology Care at Home Intervention for Patients With Lymphoma

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma
• Intervention / Treatment: Other: Home Hospital for Lymphoma

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Home Hospital for Lymphoma; Remote monitoring and home-based care designed for hospitalized patients with lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rates of completion of daily vital signs	Proportion of participants that complete daily reporting of vital signs during their home hospital admission.	1 year
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Length of home hospital admission	Number of days the participant receives home hospital care through the home hospital program.	1 year
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
Number of phone calls	Number of phone calls required per participants as well as the average duration of these calls.	1 year
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
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
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
Number of imaging studies	The number of imaging studies obtained per participant during the Home Hospital admission.	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Lymphoma; Home Care Services, Hospital-Based; Cancer Care
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: 19-613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No