Improving Cognition After Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Survivors; Cognitive Dysfunction
• Interventions: Behavioral: Exercise; Behavioral: Control

• Registration Number: NCT04049695
• Lead Sponsor: University of California, San Diego

Brief Summary

This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Detailed Description

Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Study Start: 2019-09-09
• Primary Completion: 2024-01-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 253

Inclusion Criteria

• breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
• self-report difficulties with cognition since their cancer diagnosis
• self-report low levels of moderate to vigorous physical activity
• have a Fitbit compatible device with internet
• breast cancer was treated with chemotherapy and/or hormonal therapy

Exclusion Criteria

• medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
• currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
• unable to commit to a 12-month study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise	This arm will receive a 12-month individually tailored phone and email-based exercise program.
Health & Wellness Intervention	Control	This arm will receive a 12-month health and wellness program.

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test	Baseline to 6 months	Measure of processing speed

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities	Baseline to 6 months and Baseline to 12 months	Measure of Self-Report Cognition
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test	Baseline to 12 months	Measure of processing speed

Trial Locations

Locations (1)

Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States