Nutrition Awareness Among Women With Non-Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to comply with one or more of the inclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
Educational Brochure
BehavioralThe two-page educational brochure is emailed to participants after Questionnaire 2 and before they begin Questionnaire 3.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Non-metastatic breastExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov