The COMPASSION Study

NCT ID: NCT06507930

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-03-01

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Telehealth Hospice Visits

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Claire Smith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claire Smith, MD

Role: CONTACT

claire_smith@dfci.harvard.edu

617-632-3800

Facility Contacts

Claire Smith, MD

Role: primary

claire_smith@dfci.harvard.edu

617-632-3800

Other Identifiers

24-142

Identifier Type: -

Identifier Source: org_study_id