Improving Cognition After Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2025-02-01

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.

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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.

Conditions

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Breast Cancer Survivors Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise Intervention

This arm will receive a 12-month individually tailored phone and email-based exercise program.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Health & Wellness Intervention

This arm will receive a 12-month health and wellness program.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No