Physical Activity and Neuropsychological Outcomes in a Cancer Population

Many cancer survivors experience treatment-related impairments in mental abilities such as memory, attention, and concentration (known as cognition). Research indicates that physical activity can improve cognition in healthy adults; however, little is known about whether physical activity can improve cognition among cancer survivors. This study will test whether a physical activity intervention results in improvements in cognition among breast cancer survivors, which may lead to interventions to improve cognition.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Breast Cancer Survivors
• Intervention / Treatment: Behavioral: Control; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Moores UCSD Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• breast cancer survivors; diagnosed at stage 1, 2, or 3 less than 5 years ago -
• not scheduled for or currently undergoing chemotherapy; sedentary, defined as engaging in less than 60 minutes of moderate to vigorous physical activity each week
• accessible geographically and by telephone
• have access to the internet
• endorse experience difficulties with thinking abilities
• in addition, participants on adjuvant therapy (e.g., tamoxifen or aromatase inhibitors) must be able and willing to remain on that treatment for the 3-month intervention period to prevent confounding of biomarker concentrations by treatment.

Exclusion Criteria:

• history of coronary heart disease, diabetes, stroke, orthopedic conditions that limit mobility, or any other serious medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
• other primary or recurrent invasive cancer within the last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)
• unable to commit to a 3-month intervention schedule; any condition that, in the investigators' judgment, would contraindicate increased physical activity or otherwise interfere with participation in the trial
• unable to provide a blood sample at the baseline measurement visit
• unable to speak and read English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; This arm will receive a 12-week individually tailored phone and email-based exercise program.	Behavioral: Exercise
Active Comparator: Wellness Waitlist Control; This arm will receive emails on the same schedule as the exercise arm, that cover a variety of health and wellness topics. At the end of the 12 weeks, participants will be able to start the exercise program.	Behavioral: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test	Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• Hartman SJ, Chen R, Tam RM, Narayan HK, Natarajan L, Liu L. Fitbit Use and Activity Levels From Intervention to 2 Years After: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 30;10(6):e37086. doi: 10.2196/37086.
• Hartman SJ, Weiner LS, Nelson SH, Natarajan L, Patterson RE, Palmer BW, Parker BA, Sears DD. Mediators of a Physical Activity Intervention on Cognition in Breast Cancer Survivors: Evidence From a Randomized Controlled Trial. JMIR Cancer. 2019 Oct 11;5(2):e13150. doi: 10.2196/13150.
• Weiner LS, Takemoto M, Godbole S, Nelson SH, Natarajan L, Sears DD, Hartman SJ. Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention. J Cancer Surviv. 2019 Jun;13(3):468-476. doi: 10.1007/s11764-019-00768-8. Epub 2019 May 29.
• Hartman SJ, Nelson SH, Weiner LS. Patterns of Fitbit Use and Activity Levels Throughout a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Feb 5;6(2):e29. doi: 10.2196/mhealth.8503.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 1K07CA181323-01A1 (U.S. NIH Grant/Contract)