The COMPASSION Study

Not Applicable

Recruiting

• Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Unresectable Breast Carcinoma
• Interventions: Other: Telehealth Hospice Visits

• Registration Number: NCT06507930
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Study First Posted: 2024-07-18
• Study Start: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Compassion Cohort	Telehealth Hospice Visits	25 participants will complete study procedures as follows: * Introduction to study and survey by brief, verbal consent via phone call. * At 4-6 weeks: survey completion via email or phone. * 4 weekly check-ins via Zoom or phone call with study team.

Primary Outcome Measures

Name	Time	Method
Proportion of Participant Intervention Completion	Up to 4 weeks	Feasibility of the telehealth intervention is defined as greater than or equal to 80% of enrolled participants (18 out of 25) completing greater than or equal to 66% of the planned telehealth check-ins while the participant remains alive.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States