Skip to main content
OpenTrials
Completed

NCT Number: NCT02591316

Nutrition, Physical Activity, 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Texas State University

San Marcos, Texas, 78666, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Cognition

    Time frame: Baseline

    A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery

Secondary outcomes

  1. Physical Activity

    Time frame: Baseline

    Physical activity will be measured by a waist-worn accelerometer

  2. Diet Quality

    Time frame: Baseline

    Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire

  3. Body Composition (objectively measured)

    Time frame: Baseline

    Body composition will be evaluated by BOD POD assessment

  4. Inflammatory Markers

    Time frame: Baseline

    A fasted blood sample will be collected for measurement of inflammatory markers

Other outcomes

  1. Medical History

    Time frame: Baseline

    Self-reported medical history

  2. Quality of Life

    Time frame: Baseline

    Series of questionnaires assessing various aspects of quality of life including physical and mental health

Sponsors and collaborators

Lead sponsor

Texas State University, San Marcos

Other

Registry information

Official study title

Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.