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Improving Cognition After Cancer (ICAN)

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ClinicalTrials.gov Identifier: NCT04049695
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sheri Hartman, University of California, San Diego

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 9, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test [ Time Frame: Baseline to 6 months ]
    Measure of processing speed


Secondary Outcome Measures :
  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test [ Time Frame: Baseline to 12 months ]
    Measure of processing speed

  2. Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities [ Time Frame: Baseline to 6 months and Baseline to 12 months ]
    Measure of Self-Report Cognition



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049695


Contacts
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Contact: Lindsay Dillon, MPH 8585349329 ldillon@ucsd.edu
Contact: Hava Barkai (858) 822-2779 hbarkai@ucsd.edu

Locations
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United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Sheri Hartman, PhD    858-534-9519    memorystudy@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04049695    
Other Study ID Numbers: 182113
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders