- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389967
Nutrition Awareness Among Women With Non-Metastatic Breast Cancer
This study explores perspectives of women with non-metastatic breast cancer regarding their willingness and ability to make dietary changes pertaining to foods/food products that may pose a risk to their cancer prognosis and survival.
This is a single-group study conducted entirely online. All study activities, including consent, educational brochure and surveys, will be completed remotely. Participants will receive email invitations to complete questionnaires in REDCap.
Questionnaire 1 will collect sociodemographic information (no PHI) and a brief dietary recall.
Questionnaire 2 will assess identification of ultra-processed foods. Before Questionnaire 3, participants will review a two-page educational flyer explaining the link between diet, obesity, and cancer, with information on unhealthy calories and food processing.
Questionnaire 3 will assess participants' willingness and ability to eat healthier foods and reduce unhealthy foods.
At study completion, participants will receive a thank-you message and a brief satisfaction survey.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Allison Ross
- Phone Number: 1 919-445-4905
- Email: allison_ross@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27519
- Recruiting
- UNC Cancer Hospital
-
Contact:
- Amy L Garrett, MA, CCRC
- Phone Number: 919-966-0695
- Email: amy_garrett@med.unc.edu
-
Principal Investigator:
- Kirsten A Nyrop, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >18 -Female
- Diagnosis of non-metastatic breast cancer
- Completion of primary treatment for breast cancer
- No recurrence or metastasis; or no other cancer other than basal or squamous cell
- Willingness to provide a private email address for all study activities
- Ability to read and understand English
Exclusion Criteria:
- Inability to comply with one or more of the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Non-metastatic breast
Women aged 18 or older with a diagnosis of non-metastatic breast cancer and having completed all of their primary treatment for early-stage breast cancer (Stage I, II or II); they can be on endocrine treatment.
|
The two-page educational brochure is emailed to participants after Questionnaire 2 and before they begin Questionnaire 3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness and ability to make dietary changes
Time Frame: Baseline
|
the perspectives of women with non-metastatic breast cancer on their willingness and ability to make dietary changes related to specific foods and food products will be assessed.
Responses will be collected using a patient-reported questionnaire with a 5-point Likert scale ranging from "Unwilling" to "Very Willing" and "Unable" to "Very Able."
Higher scores indicate greater willingness and ability to make healthier dietary choices.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kirsten Nyrop, PhD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 25-2834
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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