Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors

July 17, 2016 updated by: Krystle Zuniga, Texas State University, San Marcos

Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors

The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.

The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Marcos, Texas, United States, 78666
        • Texas State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female breast cancer survivors and women who have never had a previous cancer diagnosis

Description

Inclusion Criteria:

  • Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
  • age-matched controls must have no previous cancer diagnosis
  • Female
  • no history of stroke, heart attack or transient ischemic attack
  • not currently pregnant; can speak, read, and write English
  • can attend all testing sessions
  • not blind or legally blind; nonsmoker
  • no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).

Exclusion Criteria:

  • male
  • < 30 or > 70 years of age
  • breast cancer survivor > 60 months from last treatment or currently undergoing primary treatment
  • breast cancer survivor never treated with chemotherapy and/or radiation
  • previous cancer diagnosis other than breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer survivor
Inclusion criteria: Female breast cancer survivors (30-70yrs of age) that have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
Other: no intervention
Control
Females (30-70yrs of age) with no previous cancer diagnosis.
Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: Baseline
A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: Baseline
Physical activity will be measured by a waist-worn accelerometer
Baseline
Diet Quality
Time Frame: Baseline
Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire
Baseline
Body Composition (objectively measured)
Time Frame: Baseline
Body composition will be evaluated by BOD POD assessment
Baseline
Inflammatory Markers
Time Frame: Baseline
A fasted blood sample will be collected for measurement of inflammatory markers
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical History
Time Frame: Baseline
Self-reported medical history
Baseline
Quality of Life
Time Frame: Baseline
Series of questionnaires assessing various aspects of quality of life including physical and mental health
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas State University, San Marcos

Investigators

  • Principal Investigator: Krystle E Zuniga, PhD, RD, Texas State University, San Marcos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 17, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014T34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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