Recruiting

Dietary Changes

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07389967

Conditions

Breast Cancer

Breast Cancer Metastatic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Brochure

Study Details

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.

Conditions

Breast Cancer

Breast Cancer Metastatic

Study ID

NCT07389967

Start date

Jan 20, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

Educational Brochure

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

Primary outcome measure

  • Willingness and ability to make dietary changes [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Allison Ross

1 919-445-4905allison_ross@med.unc.edu

Locations

UNC Cancer Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27519

Contacts

Amy L Garrett, MA, CCRC

919-966-0695amy_garrett@med.unc.edu

Principal Investigator:

Kirsten A Nyrop, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Jan, 2026

Keywords

  • nutrition
  • diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-02-05.