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Trial Title:
The COMPASSION Study
NCT ID:
NCT06507930
Condition:
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Unresectable Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Unresectable Breast Cancer
Hospice Care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Telehealth Hospice Visits
Description:
Telehealth check-in appointments with oncology care team, MD, PA, NP, or hospice nurse,
via HIPAA compliant telehealth platform, Zoom, or by phone call.
Arm group label:
Compassion Cohort
Summary:
The aim of this research study is to better understand the in-home hospice experience for
participants, caregivers, hospice nurses, and oncology providers by conducting telehealth
check-ins between participants and caregivers and oncology care teams.
Detailed description:
The aim of this research study is to better understand the in-home hospice experience for
participants, caregivers, hospice nurses, and oncology providers by conducting telehealth
check-ins between participants and caregivers and oncology care teams.
Study procedures include giving verbal consent to participate and a one-time survey
delivered by email or phone call.
About 200 people, which includes 50 participants, 50 caregivers, 50 hospice nurses, and
about 50 oncology providers, are expected to participate in this research study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient of any gender with unresectable locally advanced or metastatic breast cancer
- Eligible for in-home hospice services and referred by DFCI clinical team to in-home
hospice = 1 week before enrollment
- Ability to conduct video or phone check-ins, even if assistance required.
- Able to provide verbal consent with a willingness to take a survey at 4-6 weeks, if
medically able
- Hospice setting is within Massachusetts
- Non-English language allowed but interpreter services must be present at each
meeting and will be coordinated by scheduling team
- Willingness to provide a caregiver/loved one's contact information for survey
contact at 4 weeks after enrollment
Exclusion Criteria:
- Unable to provide verbal consent
- Hospice care planned outside of a home setting (note: if participants start out in a
home hospice setting but later transition their hospice care to an inpatient
setting, enrollment is allowed as long as they started in a home setting)
- Hospice setting outside of Massachusetts
- Individuals who are under the age of 18, as this is not a project focused on
pediatric patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Claire Smith, MD
Phone:
617-632-3800
Email:
claire_smith@dfci.harvard.edu
Investigator:
Last name:
Claire Smith, MD
Email:
Principal Investigator
Start date:
January 2025
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06507930