NCT02591316

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

October 27, 2015

Last Update Submit

July 17, 2016

Conditions

Keywords

nutritionphysical activitybreast cancer survivorcognition

Outcome Measures

Primary Outcomes (1)

  • Cognition

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

    Baseline

Secondary Outcomes (4)

  • Physical Activity

    Baseline

  • Diet Quality

    Baseline

  • Body Composition (objectively measured)

    Baseline

  • Inflammatory Markers

    Baseline

Other Outcomes (2)

  • Medical History

    Baseline

  • Quality of Life

    Baseline

Study Arms (2)

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

Interventions

Breast cancer survivorControl

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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 ®).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas State University

San Marcos, Texas, 78666, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma

MeSH Terms

Conditions

Breast NeoplasmsCognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Krystle E Zuniga, PhD, RD

    Texas State University, San Marcos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 29, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations