Breast CancerNCT06507930
The COMPASSION Study
A study testing Telehealth Hospice Visits in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Telehealth Hospice Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Claire Smith, MD, 617-632-3800, claire_smith@dfci.harvard.edu
Claire Smith, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Telehealth Hospice Visits
- Keywords
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Breast Cancer, Hospice Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Hospice VisitsOther
Telehealth check-in appointments with oncology care team, MD, PA, NP, or hospice nurse, via HIPAA compliant telehealth platform, Zoom, or by phone call.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telehealth Hospice Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Smith, Dana-Farber Cancer Institute
- Investigators
- Claire Smith, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507930
- Sponsor's protocol ID
- 24-142
- Status last verified
- Oct 2025
- First submitted
- 12 Jul 2024
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMPASSION Study: Applying Telehealth to Innovate and Strengthen Connections for Patients With Metastatic Breast Cancer Receiving Hospice Care
- ClinicalTrials.gov ID
- NCT06507930
- Acronym / sponsor ID
- 24-142
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Telehealth Hospice Visits25 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Hospice VisitsTelehealth check-in appointments with oncology care team, MD, PA, NP, or hospice nurse, via HIPAA compliant telehealth platform, Zoom, or by phone call. | Other | Compassion Cohort |
Primary outcome
Proportion of Participant Intervention Completion
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Smith, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Hospice Visits in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Smith, MD (617-632-3800, claire_smith@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participant Intervention Completion (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.