Improving Cognition After Cancer

Cognitive Dysfunction Clinical Trial

— ICAN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04049695
• Other study ID #: 182113
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 253
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Cognitive Dysfunction

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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