Adaptation of a Values Assessment Tool

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Metastatic Breast Cancer; Cancer

Treatments: Behavioral: Values Assessment Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07068477

LCCC2201

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician.

Full description

Incorporating patient values into shared decision-making is essential for individuals diagnosed with metastatic cancer. This is especially critical for women who identify as Black/African American, Latinx/Hispanic, or American Indian/Alaskan Native, as research indicates these groups face a higher risk of poor prognostic communication, worse health outcomes, and increased likelihood of metastatic cancer diagnoses compared to non-Hispanic White adults.

Black/African American women in the South, including North Carolina, experience the highest breast cancer mortality rates in the United States. In North Carolina, the majority of women diagnosed with metastatic breast cancer (mBC) are either non-Hispanic White (159 per 100,000) or Black/African American (164 per 100,000). This study aims to ensure that at least 40% of participants are Black/African American women.

While the Short Graphic Values History (SGVH) tool has been used in general ambulatory care, it has not been tested or adapted for use in cancer care settings. Based on interviews with individuals living with mBC and their care partners, a new Values Assessment Tool (VAsT) has been developed for integration into cancer care.

This single-arm prospective study will enroll 40 women with mBC and their caregivers. Baseline data will be collected at diagnosis, followed by deployment of the VAsT in clinic settings. Follow-up feedback will be obtained to assess real-world usability and relevance of the tool in supporting shared decision-making in cancer care.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Values assessment tool

Experimental group

Description:

Participants are assessed at baseline and every clinic visit for 3 months

Treatment:

Behavioral: Values Assessment Tool