Cancer, Metastatic Breast Cancer
Conditions
Keywords
African American, Latinx, Alaskan Native, Short Graphic Values History
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.
Detailed 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.
Interventions
BEHAVIORALValues Assessment Tool
The Values Assessment Tool was provided to the participants at baseline and every clinic visit for 3 months
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional engagement | Baseline and every clinic visit for 3 months | 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. |
| Decisional conflict | Baseline and every clinic visit for 3 months | 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 \[extremely high decisional conflict\] |
| Communication perceptions | Baseline and every clinic visit for 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants who started and completed | Baseline and 3 months | The number of participants who started and completed using the Values Assessment Tool will be presented. |
| Shared decision making evaluation | Baseline and 3 months | Shared decision-making will be evaluated through a combination of qualitative semi-structured interviews and audio recordings of clinical encounters with enrolled patient participants, conducted both before and after the use of the Short Graphic Values History (SGVH) tools. Open-ended feedback from participants will undergo content analysis to identify key themes. These insights will be used to prioritize recommendations for refining the next iteration of the SGVH tool intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLorinda Coombs, PhD, FNP-BC, AOCNP
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed