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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06582615
Status
Recruiting
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Conditions

  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo dried blood spot collection
  • Cognitive Assessment — PROCEDURE
    Ancillary studies
  • Dietary Intervention — OTHER
    Receive MIND counseling sessions
  • Dietary Intervention — OTHER
    Follow a personalized diet
  • Dietary Intervention — OTHER
    Receive general health recommendations counseling sessions
  • Medical Device Usage and Evaluation — OTHER
    Wear a Fitbit
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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

Key Dates

Start date
Oct 28, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (MIND-TNBC counseling)
    Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.
  • Active Comparator: Arm II (general health recommendations counseling)
    Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.

Primary Outcome Measure

Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score [ Time Frame: Baseline up to 6 months post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06519
Maryam Lustberg, MD, MPH
[email protected]
203-200-2328
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Tonya Orchard, PhD
[email protected]
614-292-7241
Tonya Orchard (PRINCIPAL_INVESTIGATOR)

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Yale University· New Haven, CTOhio State University Comprehensive Cancer Center· Columbus, OH

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