Patient-centered Communication About Healthy Weight in Early Breast Cancer

NCT04504201 | Completed DMC

• 1 other identifier: LCCC 1954
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Feedback from patients regarding healthy weight communication through focus groups

  Summary of conversation based on 5A's Behavioral Change Model

  3 year

Secondary Outcomes (1)

• Feedback from oncology providers regarding healthy weight communication through semi-structured interview

  3 year

Study Arms (2)

Early Breast Cancer Patients

Early breast cancer patients (Stage I-III) who have completed primary treatment with a current Body mass index (BMI) over 30.

Other: Focus Group

Medical Oncology Clinicians

Oncology providers associated with community-based practices

Other: Focus Group

Interventions

Focus Group OTHER

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

Early Breast Cancer Patients; Medical Oncology Clinicians

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast Cancer patients and Breast oncology providers will be eligible for this study

You may qualify if:

• 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

You may not qualify if:

• Cannot understand and speak English
• Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN
• associated with community-based practices

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• American Cancer Society, Inc.: collaborator
• Pfizer: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kirsten Nyrop, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: June 15, 2020
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

US (1)