Physical Activity and Neuropsychological Outcomes in a Cancer Population

NCT02332876 | Completed Results

• 1 other identifier: 1K07CA181323-01A1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Dysfunction; Breast Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Behavioral: Exercise

Wellness Waitlist Control

ACTIVE COMPARATOR

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

Interventions

Exercise BEHAVIORAL

Exercise Intervention

Control BEHAVIORAL

Wellness Waitlist Control

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (4)

• 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.

  PMID: 35771607 DERIVED

• 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.

  PMID: 31605514 DERIVED

• 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.

  PMID: 31144265 DERIVED

• 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.

  PMID: 29402761 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Sheri Hartman
• Organization: University of San Diego, California

sjhartman@ucsd.edu

8585349235

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 7, 2015
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 11, 2018
• Results First Posted: July 11, 2018

Record last verified: 2018-07

Locations

US (1)