The COMPASSION Study

NCT06507930 | Recruiting DMC

• 1 other identifier: 24-142
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Breast Carcinoma

Keywords

Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Breast Cancer; Hospice Care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Usual Care Cohort

NO INTERVENTION

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.

Compassion Cohort

EXPERIMENTAL

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

Interventions

Telehealth Hospice Visits OTHER

Telehealth check-in appointments with oncology care team, MD, PA, NP, or hospice nurse, via HIPAA compliant telehealth platform, Zoom, or by phone call.

Compassion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Claire Smith, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Smith, MD

CONTACT

617-632-3800; claire_smith@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)