Breast Cancer Clinical Trial
Official title:
Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer
| NCT number | NCT04504201 |
| Other study ID # | LCCC 1954 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 15, 2020 |
| Est. completion date | September 29, 2020 |
| Verified date | July 2022 |
| Source | UNC Lineberger Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | September 29, 2020 |
| Est. primary completion date | September 29, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 99 Years |
| Eligibility | Inclusion Criteria for Breast Cancer Cohort: - Age 21 or older - Diagnosed with early breast cancer, Stages I-III - Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years - Body mass Index of equal or greater than 30 Exclusion Criteria: - Cannot understand and speak English INclusion Criteria for Oncology provider cohort: - Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN - associated with community-based practices |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | American Cancer Society, Inc., Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feedback from patients regarding healthy weight communication through focus groups | Summary of conversation based on 5A's Behavioral Change Model | 3 year | |
| Secondary | Feedback from oncology providers regarding healthy weight communication through semi-structured interview | Provider suggestions on how to implement 5A's Behavioral change model into patient care | 3 year |
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