Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:27 AM
Study NCT ID:
NCT07389967
Status:
RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Awareness Among Women With Non-Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Willingness and ability to make dietary changes', 'timeFrame': 'Baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrition', 'diet'], 'conditions': ['Breast Cancer', 'Breast Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/patientcare/clinical-trials/clinical-trials', 'label': 'University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nQuestionnaire 1 will collect sociodemographic information (no PHI) and a brief dietary recall.\n\nQuestionnaire 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.\n\nQuestionnaire 3 will assess participants' willingness and ability to eat healthier foods and reduce unhealthy foods.\n\nAt study completion, participants will receive a thank-you message and a brief satisfaction survey."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 -Female\n* Diagnosis of non-metastatic breast cancer\n* Completion of primary treatment for breast cancer\n* No recurrence or metastasis; or no other cancer other than basal or squamous cell\n* Willingness to provide a private email address for all study activities\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Inability to comply with one or more of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07389967', 'briefTitle': 'Nutrition Awareness Among Women With Non-Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Nutrition Awareness Among Women With Non-Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '25-2834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-metastatic breast', 'description': '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.', 'interventionNames': ['Behavioral: Educational Brochure']}], 'interventions': [{'name': 'Educational Brochure', 'type': 'BEHAVIORAL', 'description': 'The two-page educational brochure is emailed to participants after Questionnaire 2 and before they begin Questionnaire 3.', 'armGroupLabels': ['Non-metastatic breast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27519', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy L Garrett, MA, CCRC', 'role': 'CONTACT', 'email': 'amy_garrett@med.unc.edu', 'phone': '919-966-0695'}, {'name': 'Kirsten A Nyrop, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Cancer Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'centralContacts': [{'name': 'Allison Ross', 'role': 'CONTACT', 'email': 'allison_ross@med.unc.edu', 'phone': '1 919-445-4905'}], 'overallOfficials': [{'name': 'Kirsten Nyrop, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Lineberger Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}