Study Stopped
Study halted prematurely and will not resume due to poor accrual.
Home Hospital for Lymphoma
Supportive Oncology Care at Home Intervention for Patients With Lymphoma
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lymphoma
Started Jun 2020
Shorter than P25 for not_applicable lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 6, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedOctober 28, 2022
October 1, 2022
7 months
June 6, 2020
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Acceptability of the intervention
1 year
Rates of completion of daily vital signs
1 year
Rates of Adverse Events
1 year
Other Outcomes (10)
Symptom burden (Edmonton Symptom Assessment System-revised - ESAS-r)
1 year
Psychological distress (Hospital Anxiety and Depression Scale - HADS)
1 year
Quality of life (Functional Assessment of Cancer Therapy-General - FACT-G)
1 year
- +7 more other outcomes
Study Arms (1)
Home Hospital for Lymphoma
EXPERIMENTALThe 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.
Interventions
Remote monitoring and home-based care designed for hospitalized patients with lymphoma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areej El-Jawahri, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 6, 2020
First Posted
June 9, 2020
Study Start
June 1, 2020
Primary Completion
January 1, 2021
Study Completion
January 30, 2021
Last Updated
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
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.