CClinicalTrials.gg
Active, not recruitingNCT04049695ICANUpdated Aug 23, 2024

Improving Cognition After Cancer

An interventional study of Exercise and Control in Breast Cancer Survivors and Cognitive Dysfunction, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
253
Allocation
Randomized
Ages
40 Years and older
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Breast Cancer Survivors
  • Cognitive Dysfunction
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 253 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
253 participants (actual)

Study arms

  • Experimental
    Exercise Intervention

    This arm will receive a 12-month individually tailored phone and email-based exercise program.

    Behavioral: Exercise

  • Active comparator
    Health & Wellness Intervention

    This arm will receive a 12-month health and wellness program.

    Behavioral: Control

Interventions

  • BehavioralExercise

    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

  • BehavioralControl

    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

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What researchers measure

Primary outcomes

  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test

    Measure of processing speed

    Time frame: Baseline to 6 months

Secondary outcomes

  1. National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test

    Measure of processing speed

    Time frame: Baseline to 12 months

  2. Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities

    Measure of Self-Report Cognition

    Time frame: Baseline to 6 months and Baseline to 12 months

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Study locations

1 site
  • Moores UCSD Cancer Center
    La Jolla, California 92093, United States
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References and documents

Study documents

  • Informed consent form · Dec 14, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04049695
Lead sponsor
University of California, San Diego
Responsible party
Sheri Hartman (Assistant Professor, University of California, San Diego) — Principal investigator
First posted
Aug 8, 2019
Start date
Sep 9, 2019
Primary completion
Jan 19, 2024
Completion
Feb 1, 2025 (estimated)
Last update
Aug 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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