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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Tonya S Orchard, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Diet; Chemotherapy; Cognitive impairment; Breast cancer survivor; Remote assessment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Hyperinsulinism; Breast Neoplasms; Insulin Resistance
• Other Study ID Numbers: 2021C0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No