Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors

NCT05048108 | Completed

• 1 other identifier: OSU-21100
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and Type 2 Diabetes Mellitus (T2DM). Women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. Additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. Many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. Omega-3 polyunsaturated fatty acids (PUFAs) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. The purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 PUFAs with insulin resistance and cognitive function in obese breast cancer survivors. Due to the global pandemic caused by the coronavirus disease of 2019 (COVID-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. The study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. Participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. Participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. Upon receipt of blood samples and completion of all study questionnaires, participation will be complete.

Conditions

Breast Cancer; Obesity

Keywords

Chemotherapy; Cognitive impairment; Breast cancer survivor; Diet; Remote assessment

Outcome Measures

Primary Outcomes (1)

• Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection

  Homeostatic model assessment for insulin resistance (HOMA-IR) is calculated by fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Insulin and glucose measures will be obtained from the dried blood spot collection.

  One day

Secondary Outcomes (4)

• Remote assessment of cognition using the Hopkins Verbal Learning Test

  One day

• Remote assessment of cognition using the WAIS-IV Digit Span

  One day

• Remote assessment of cognition using the Oral Trail Making Test

  One day

• Remote assessment of cognition using the COWA Test

  One day

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors from the Central Ohio area, including those who were seen at The Ohio State University Wexner Medical Center James Cancer Hospital for cancer treatment.

You may qualify if:

• Stage I-III breast cancer diagnosis
• Between 1-4 years post-breast cancer diagnosis
• Postmenopausal (at least 1 year post-menses)
• Ability to access and use internet resources, including Zoom video calls
• English speaking

You may not qualify if:

• Diagnosis of type 2 diabetes mellitus
• Unwillingness to complete finger prick for blood collection

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood dried blood spots

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tonya S Orchard, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 17, 2021
• Study Start: January 18, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)