NCT07389967

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
8mo left

Started Jan 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 20, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

nutritiondiet

Outcome Measures

Primary Outcomes (1)

  • Willingness and ability to make dietary changes

    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

Study Arms (1)

Non-metastatic breast

EXPERIMENTAL

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.

Behavioral: Educational Brochure

Interventions

The two-page educational brochure is emailed to participants after Questionnaire 2 and before they begin Questionnaire 3.

Non-metastatic breast

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Cancer Hospital

Chapel Hill, North Carolina, 27519, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kirsten Nyrop, PhD

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations