- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504201
Patient-centered Communication About Healthy Weight in Early Breast Cancer
Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer
Study Overview
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:
Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups
Secondary Objective
- Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
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
|
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
Investigators
- Principal Investigator: Kirsten Nyrop, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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