NCT07068477

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
3mo left

Started Jan 2023

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jan 2023Aug 2026

Study Start

First participant enrolled

January 5, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2026

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

June 26, 2025

Last Update Submit

October 9, 2025

Conditions

CancerMetastatic Breast Cancer

Keywords

African AmericanLatinxAlaskan NativeShort Graphic Values History

Outcome Measures

Primary Outcomes (3)

  • Decisional engagement

    Values Assessment Tool participants will be assessed using decisional engagement, Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.

    Baseline and every clinic visit for 3 months

  • Decisional conflict

    Decisional Conflict will be assessed using the Decisional Conflict Scale (10-item low literacy version). Scoring and Interpretation: Items are given a score value of: 0 = 'yes'; 2 = 'unsure'; 4 = 'no' Total Score: 10 items \[items 1-10 inclusive\] are: a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]

    Baseline and every clinic visit for 3 months

  • Communication perceptions

    Communication perceptions will be assessed using Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.

    Baseline and every clinic visit for 3 months

Secondary Outcomes (2)

  • The number of participants who started and completed

    Baseline and 3 months

  • Shared decision making evaluation

    Baseline and 3 months

Study Arms (1)

Values assessment tool

EXPERIMENTAL

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

Behavioral: Values Assessment Tool

Interventions

Values Assessment ToolBEHAVIORAL

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

Values assessment tool

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Diagnosed with metastatic breast cancer.
  • Understand and read English.
  • Receive care or anticipate receiving care at the North Carolina Cancer Hospital ambulatory cancer clinic or affiliated community cancer clinic.
  • Able to understand and participate in study procedures for length of study.

You may not qualify if:

  • Unable to provide consent, unable to communicate verbally.
  • Unable to understand or read English.
  • Enrolled in hospice care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lorinda Coombs, PhD, FNP-BC, AOCNP

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Crowder

CONTACT

(919) 307-7745victoria.crowder@unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 16, 2025

Study Start

January 5, 2023

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

August 24, 2026

Last Updated

October 10, 2025

Record last verified: 2025-10

Locations

US(1)