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Physical Activity and Neuropsychological Outcomes in a Cancer Population

Primary Purpose

Cognitive Dysfunction, Breast Cancer Survivors

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Control

About this trial

This is an interventional treatment trial for Cognitive Dysfunction

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Moores UCSD Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Intervention

Wellness Waitlist Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02332876

First Posted

December 23, 2014

Last Updated

July 9, 2018

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT02332876

Brief Title

Physical Activity and Neuropsychological Outcomes in a Cancer Population

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Dysfunction, Breast Cancer Survivors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Wellness Waitlist Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Type

Behavioral

Intervention Name(s)

Control

Primary Outcome Measure Information:

Title

National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test

Description

Time Frame

Baseline to 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Moores UCSD Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35771607

Citation

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.

Results Reference

derived

PubMed Identifier

31605514

Citation

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.

Results Reference

derived

PubMed Identifier

31144265

Citation

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.

Results Reference

derived

PubMed Identifier

29402761

Citation

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.

Results Reference

derived

Learn more about this trial

Physical Activity and Neuropsychological Outcomes in a Cancer Population

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