Improving Cognition After Cancer (ICAN)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Cognitive Dysfunction; Breast Cancer Survivors
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Moores UCSD Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; This arm will receive a 12-month individually tailored phone and email-based exercise program.	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
Active Comparator: Health & Wellness Intervention; This arm will receive a 12-month health and wellness program.	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): January 19, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Skin Diseases; Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Breast Diseases; Cognition Disorders; Breast Neoplasms; Cognitive Dysfunction
• Other Study ID Numbers: 182113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No