Back to resultsImproving Cognition After Cancer (ICAN)
Primary Purpose
Breast Cancer Survivors, Cognitive Dysfunction
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Survivors
Eligibility Criteria
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
Sites / Locations
- Moores UCSD Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Intervention
Health & Wellness Intervention
Arm Description
This arm will receive a 12-month individually tailored phone and email-based exercise program.
This arm will receive a 12-month health and wellness program.
Outcomes
Primary Outcome Measures
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Measure of processing speed
Secondary Outcome Measures
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Measure of processing speed
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Measure of Self-Report Cognition
Full Information
NCT ID
NCT04049695
First Posted
August 6, 2019
Last Updated
August 9, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04049695
Brief Title
Improving Cognition After Cancer
Acronym
ICAN
Official Title
A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors, Cognitive Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
This arm will receive a 12-month individually tailored phone and email-based exercise program.
Arm Title
Health & Wellness Intervention
Arm Type
Active Comparator
Arm Description
This arm will receive a 12-month health and wellness program.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Description
Measure of processing speed
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Description
Measure of processing speed
Time Frame
Baseline to 12 months
Title
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Description
Measure of Self-Report Cognition
Time Frame
Baseline to 6 months and Baseline to 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Cognition After Cancer
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