Adaptation of a Values Assessment Tool

NCT ID: NCT07068477

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2026-08-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Values assessment tool

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

Group Type EXPERIMENTAL

Values Assessment Tool

Intervention Type BEHAVIORAL

The Values Assessment Tool was provided to the participants at baseline and every clinic visit for 3 months

Interventions

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Values Assessment Tool

The Values Assessment Tool was provided to the participants at baseline and every clinic visit for 3 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

2. Unable to provide consent, unable to communicate verbally.
3. Unable to understand or read English.
4. Enrolled in hospice care.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorinda Coombs, PhD, FNP-BC, AOCNP

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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UNC Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria Crowder

Role: CONTACT

(919) 307-7745

Facility Contacts

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Victoria Crowder

Role: primary

(919) 307-7745

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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LCCC2201

Identifier Type: -

Identifier Source: org_study_id

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