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OpenTrials
Active, Not Recruiting

NCT Number: NCT04049695

Improving Cognition After Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

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

Control

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

Primary outcomes

  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test

    Time frame: Baseline to 6 months

    Measure of processing speed

Secondary outcomes

  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test

    Time frame: Baseline to 12 months

    Measure of processing speed

  2. Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities

    Time frame: Baseline to 6 months and Baseline to 12 months

    Measure of Self-Report Cognition

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: ICAN

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 8, 2019
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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