Adapting a values assessment tool for women with metastatic breast cancer
Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)
This project will try a Values Assessment Tool during clinic visits to help women with metastatic breast cancer and their caregivers make decisions and talk with their oncology team.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07068477 on ClinicalTrials.gov |
What this trial studies
This single-arm prospective project will enroll 40 women with metastatic breast cancer and their caregivers at UNC-affiliated ambulatory clinics. Participants will complete baseline measures at diagnosis, use the adapted Values Assessment Tool (VAsT) in clinic, and provide follow-up feedback on usability and communication outcomes. The team aims for at least 40% of participants to be Black/African American women and focuses on including Latinx and American Indian/Alaskan Native participants. Collected data will inform whether the VAsT fits cancer care workflows and supports shared decision-making in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults diagnosed with metastatic breast cancer who receive or expect to receive care at the North Carolina Cancer Hospital or affiliated community clinics and can provide consent and participate with a caregiver.
Not a fit: Patients who do not read or understand English, are enrolled in hospice, unable to consent or communicate verbally, or who receive care outside the participating clinics are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the tool could reduce decisional conflict and improve communication about prognosis and treatment preferences for women with metastatic breast cancer.
How similar studies have performed: A related Short Graphic Values History tool has been used in general ambulatory care, but adapting and testing a values tool specifically for cancer care and metastatic breast cancer is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age ≥18 years 2. Diagnosed with metastatic breast cancer. 3. Understand and read English. 4. Receive care or anticipate receiving care at the North Carolina Cancer Hospital ambulatory cancer clinic or affiliated community cancer clinic. 5. Able to understand and participate in study procedures for length of study. Exclusion Criteria 1. All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation: 2. Unable to provide consent, unable to communicate verbally. 3. Unable to understand or read English. 4. Enrolled in hospice care.
Where this trial is running
Chapel Hill, North Carolina
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lorinda Coombs, PhD, FNP-BC, AOCNP — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Victoria Crowder
- Email: victoria.crowder@unc.edu
- Phone: (919) 307-7745
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.