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

Study Overview
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Brief Summary
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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.

Official Title
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Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors at Risk for Cognitive Impairment

Conditions
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Breast Cancer, Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of type 2 diabetes mellitus Unwillingness to complete finger prick for blood collection

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remote assessment of cognition using the Hopkins Verbal Learning Test | Assess cognition remotely through a zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. | One day | 
| Remote assessment of cognition using the WAIS-IV Digit Span | Assess cognition remotely through a zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. | One day | 
| Remote assessment of cognition using the Oral Trail Making Test | Assess cognition remotely through a zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. | One day | 
| Remote assessment of cognition using the COWA Test | Assess cognition remotely through a zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Cognitive impairment, Breast cancer survivor, Diet, Remote assessment