Improving Cognition After Cancer
ICAN
A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors
1 other identifier
interventional
253
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedAugust 23, 2024
August 1, 2024
4.4 years
August 6, 2019
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Measure of processing speed
Baseline to 6 months
Secondary Outcomes (2)
National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
Baseline to 12 months
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
Baseline to 6 months and Baseline to 12 months
Study Arms (2)
Exercise Intervention
EXPERIMENTALThis arm will receive a 12-month individually tailored phone and email-based exercise program.
Health & Wellness Intervention
ACTIVE COMPARATORThis arm will receive a 12-month health and wellness program.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
September 9, 2019
Primary Completion
January 19, 2024
Study Completion
February 1, 2025
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share