Improving Cognition After Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors

Conditions
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Breast Cancer Survivors, Cognitive Dysfunction

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>This arm will receive a 12-month individually tailored phone and email-based exercise program. | Behavioral: Exercise<br>* This intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity<br>|
| Active Comparator: Health & Wellness Intervention<br>This arm will receive a 12-month health and wellness program. | Behavioral: Control<br>* This intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test | Measure of processing speed | Baseline to 6 months | 

Secondary Outcome Measures

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