The COMPASSION Study

The COMPASSION Study: Applying Telehealth to Innovate and Strengthen Connections for Patients With Metastatic Breast Cancer Receiving Hospice Care

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Unresectable Breast Carcinoma
• Intervention / Treatment: Other: Telehealth Hospice Visits

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Smith, MD; Phone Number: 617-632-3800; Email: claire_smith@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Claire Smith, MD; Phone Number: 617-632-3800; Email: claire_smith@dfci.harvard.edu
      • Principal Investigator: Claire Smith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Cohort; 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.
Experimental: Compassion Cohort; 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.	Other: Telehealth Hospice Visits; Telehealth check-in appointments with oncology care team, MD, PA, NP, or hospice nurse, via HIPAA compliant telehealth platform, Zoom, or by phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participant Intervention Completion	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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Claire Smith, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; Hospice Care; Unresectable Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 24-142

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 Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No