Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06507930

Conditions

Breast Cancer

Metastatic Breast Cancer

Advanced Breast Cancer

Unresectable Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telehealth Hospice Visits

Study Details

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

Study ID

NCT06507930

Start date

Sep 1, 2024

Status verified date

Oct, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Proportion of Participant Intervention Completion [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Claire Smith, MD

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Claire Smith, MD

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

Principal Investigator:

Claire Smith, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • Breast Cancer
  • Metastatic Breast Cancer
  • Advanced Breast Cancer
  • Unresectable Breast Cancer
  • Hospice Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-10-09.