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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "Patient-Center Communication about Healthy Weigh in clinical practice Primary Objective: 1. Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups Secondary Objective 2. Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Focus Group
Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (3)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center American Cancer Society, Inc., Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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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