RECRUITING

Food for Thought - a Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression. Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions. Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely. Participants will: * Be randomized to MIND or GHC interventions * Complete all study measures remotely (by online questionnaires, virtual visits and mail ) * Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks * Be sent some of the key foods in the MIND eating plan during the MIND intervention * Be contacted for follow-up measures 6 months after interventions

Official Title

Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer

Quick Facts

Study Start:2024-10-28
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06582615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 40-65 years
  2. * Female with newly diagnosed stage II-III triple negative breast cancer
  3. * Within 3 weeks prior to starting neoadjuvant chemotherapy OR up to 6 months after starting neoadjuvant chemotherapy
  4. * Ability to access and use internet resources, including video calls using Zoom platform
  5. * English speaking
  1. * History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
  2. * Current healthy eating pattern reflected by high MIND diet score (e.g. \> 8)
  3. * Unwilling/unable to eat \> 2 types of MIND food (e.g. avoids \> 2 categories or food groups such as leafy greens, olive oil and non-fried fish)
  4. * Currently pregnant
  5. * Unable to give informed consent

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Tonya Orchard, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06519
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Tonya Orchard, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-28
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage II Breast Cancer AJCC V8
  • Anatomic Stage III Breast Cancer AJCC V8
  • Triple-Negative Breast Carcinoma