Patient-centered Communication About Healthy Weight in Early Breast Cancer

July 26, 2022 updated by: UNC Lineberger Comprehensive Cancer Center

Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.
Medical Oncology Clinicians
Oncology providers associated with community-based practices
Other: Focus Group
Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback from patients regarding healthy weight communication through focus groups
Time Frame: 3 year
Summary of conversation based on 5A's Behavioral Change Model
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback from oncology providers regarding healthy weight communication through semi-structured interview
Time Frame: 3 year
Provider suggestions on how to implement 5A's Behavioral change model into patient care
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Pfizer
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Kirsten Nyrop, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2020

Primary Completion (ACTUAL)

September 29, 2020

Study Completion (ACTUAL)

September 29, 2020

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 1954

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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