ICAN: Improving Cognition After Cancer

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT04049695

Collaborator

(none)

250

Enrollment

Location

Arms

52.8

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivors Cognitive Dysfunction	Behavioral: Exercise Behavioral: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2019

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test [Baseline to 6 months]
Measure of processing speed

Secondary Outcome Measures

National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test [Baseline to 12 months]
Measure of processing speed
Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities [Baseline to 6 months and Baseline to 12 months]
Measure of Self-Report Cognition

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moores UCSD Cancer Center	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheri Hartman, Assistant Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT04049695

Other Study ID Numbers:

182113

First Posted:

Aug 8, 2019

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Cognitive Dysfunction

Study Results

No Results Posted as of Jan 27, 2022