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Home Hospital for Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Hospital for Lymphoma
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma focused on measuring Lymphoma, Home Care Services, Hospital-Based, Cancer Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home Hospital for Lymphoma

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
Rates of completion of daily vital signs
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
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.

Full Information

First Posted
June 6, 2020
Last Updated
October 26, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04423848
Brief Title
Home Hospital for Lymphoma
Official Title
Supportive Oncology Care at Home Intervention for Patients With Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume due to poor accrual.
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, Home Care Services, Hospital-Based, Cancer Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Hospital for Lymphoma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Hospital for Lymphoma
Intervention Description
Remote monitoring and home-based care designed for hospitalized patients with lymphoma
Primary Outcome Measure Information:
Title
enrollment rate
Description
The primary endpoint is feasibility. The proposed intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study
Time Frame
1 year
Title
retention rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability of the intervention
Description
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.
Time Frame
1 year
Title
Rates of completion of daily vital signs
Description
Proportion of participants that complete daily reporting of vital signs during their home hospital admission.
Time Frame
1 year
Title
Rates of Adverse Events
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
Description
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.
Time Frame
1 year
Title
Psychological distress (Hospital Anxiety and Depression Scale - HADS)
Description
Change in psychological distress as measured by the HADS, with subscale ranges from 0-21 with higher scores indicating worse psychological distress.
Time Frame
1 year
Title
Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
Description
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.
Time Frame
1 year
Title
Length of home hospital admission
Description
Number of days the participant receives home hospital care through the home hospital program.
Time Frame
1 year
Title
Number of home visits
Description
Number of home visits required, their average duration, the issues addressed at home, and the interventions delivered to participants at their home.
Time Frame
1 year
Title
Number of phone calls
Description
Number of phone calls required per participants as well as the average duration of these calls.
Time Frame
1 year
Title
Number of urgent visits
Description
The number of urgent visits to clinic per participant and the proportion of participants who have an urgent visit to clinic.
Time Frame
1 year
Title
Number of emergency department (ED) visits The number of imaging tests ordered during home hospital admission
Description
The number of emergency department (ED) visits per participant and the proportion of participants who have an ED visit.
Time Frame
1 year
Title
Number of hospital readmissions
Description
The number of hospital readmissions in 30 days per participant and the proportion of participants who have a hospital readmission within 30 days.
Time Frame
1 year
Title
Number of imaging studies
Description
The number of imaging studies obtained per participant during the Home Hospital admission.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areej El-Jawahri, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Home Hospital for Lymphoma

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