Physical Activity and Neuropsychological Outcomes in a Cancer Population

Cognitive Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332876
• Other study ID #: 1K07CA181323-01A1
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Cognitive Dysfunction

Intervention

Behavioral:
• Exercise

• Control

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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