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Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment (ReFLECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edward McAuley, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT02523677
First received: August 10, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose

The purpose of this study is to examine relationships among lifestyle behaviors (i.e., physical activity, sleep), cognitive function (i.e., memory, processing speed, and executive function), and quality of life in breast cancer patients and survivors across time. The investigators will compare the strength of these relationships across age cohorts and time since treatment and diagnosis. Participants will complete a battery of questionnaires and a set of cognitive tests on an iPad app specifically tailored for this study. A subset of participants will also wear an accelerometer for seven days. Data will be collected at baseline and 6-month follow-up.

This research is critical to identifying potentially important approaches to improving health outcomes and quality of life in breast cancer patients and survivors. Previous research provides evidence of the influence of lifestyle behaviors on cognition and quality of life in healthy aging populations. However, despite data indicating cancer's negative impact on lifestyle behaviors, cognition, and quality of life, very few studies have investigated interactions among these factors in cancer patients and survivors.


Condition
Breast Cancer Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Edward McAuley, University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • Change in Executive Function [ Time Frame: Baseline, 6 months ]
    Executive Function will be expressed as a composite score of the following cognitive tests: Flanker, Task-Switch, Trails A&B, Mazes

  • Change in Working Memory [ Time Frame: Baseline, 6 months ]
    Working Memory will be expressed as a composite score of the following cognitive tests: N-Back, Spatial Working Memory, Spatial Span, and Swap

  • Change in Speed of Processing [ Time Frame: Baseline, 6 months ]
    Speed of Processing will be expressed as a composite score of the following cognitive tests: Digital Symbols Substitution, Flanker, Speed, Task-Switch, and Trails A&B


Secondary Outcome Measures:
  • Medical Health History [ Time Frame: Baseline, 6 months ]
    Medical health history will be measured at baseline and 6-month follow-up to identify any changes to participants' health status during the study period. If no changes are observed, baseline values may be used as covariates or moderators in data analyses.

  • Change in Sleep Quality (objectively measured) [ Time Frame: Baseline, 6 months ]
    Change in sleep quality as measured by a wrist-worn accelerometer will be examined as a predictor of change in executive function, working memory, and speed of processing.

  • Change in Physical Activity (objectively measured) [ Time Frame: Baseline, 6 months ]
    Change in physical activity as measured by a waist-worn accelerometer will be examined as a predictor of change in executive function, working memory, and speed of processing.


Other Outcome Measures:
  • Change in Sleep Quality (self-report) [ Time Frame: Baseline, 6 months ]
    Change in sleep quality as measured by the Pittsburgh Sleep Quality Index will be examined as a predictor of change in executive function, working memory, and speed of processing.

  • Change in Physical Activity (self-report) [ Time Frame: Baseline, 6 months ]
    Change in physical activity as measured by the Godin Leisure-Time Exercise Questionnaire will be examined as a predictor of change in executive function, working memory, and speed of processing.

  • Change in Sitting Time [ Time Frame: Baseline, 6 months ]
    Change in sitting time as measured by the Sitting Time Questionnaire will be examined as a predictor of change in executive function, working memory, and speed of processing.

  • Change in Sedentary Activity [ Time Frame: Baseline, 6 months ]
    Change in sedentary activity as measured by the Longitudinal Aging Study Amsterdam Sedentary Behavior Questionnaire will be examined as a predictor of change in executive function, working memory, and speed of processing.

  • Change in Current Symptoms [ Time Frame: Baseline, 6 months ]
    Change in breast cancer related symptoms as measured by the Functional Assessment of Cancer Therapy - Breast will be examined as a potential confounder or moderator of the relationship between physical activity and cognitive function.

  • Change in Fatigue [ Time Frame: Baseline, 6 months ]
    Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy 13-Item Fatigue Scale will be examined as a potential confounder or moderator of the relationship between physical activity and cognitive function.

  • Change in Anxiety and Depression [ Time Frame: Baseline, 6 months ]
    Change in anxiety and depression as measured by the Hospital Anxiety and Depression Scale will be examined as potential confounders or moderators of the relationship between physical activity and cognitive function.

  • Change in Quality of Life [ Time Frame: Baseline, 6 months ]
    Relationships between change in physical activity and cognitive function and change in quality of life as measured by the Satisfaction with Life Scale will be examined.

  • Change in Memory [ Time Frame: Baseline, 6 months ]
    Change in memory as measured by the Memory Controllability Inventory will be examined as an outcome of changes in sleep quality and physical activity.

  • Change in Forgetfulness [ Time Frame: Baseline, 6 months ]
    Change in forgetfulness as measured by the Frequency of Forgetting Questionnaire will be examined as an outcome of changes in sleep quality and physical activity.


Enrollment: 456
Study Start Date: July 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Interested individuals will visit the ReFLECT Study website (www.reflectstudies.org) to learn more about the study and receive instructions on how to participate. Individuals will be instructed to create a username (email address) and password for BrainBaseline© (www.BrainBaseline.com; Digital Artefacts, Iowa City, IA). While BrainBaseline© is a commercially available mobile app, a version specifically tailored for this study will be used. The website directions will include information on how to download the BrainBaseline© iPad app (for ReFLECT) from the iTunes store. Each time a participant closes and reopens the iPad app, she will be required to enter her BrainBaseline© username and password. Upon opening the iPad app for the first time, the individual will be asked to confirm their eligibility for the study. If eligible, the individual will proceed to the consent form. Participants will electronically sign the Institutional Review Board-approved informed consent form before completing a battery of questionnaires assessing demographics, medical history, physical activity, sedentary behavior, sleep, fatigue, quality of life, satisfaction with life, depressive symptoms, and perceived memory. Individuals cannot view the questionnaires until they have electronically signed the consent form. Participants will also be asked to complete a set of ten evidence-based cognitive tests assessing attention, speed of processing, and executive function. Descriptions of the tests are available at www.BrainBaseline.com/assessments. The questionnaires are expected to take approximately 45 minutes and the cognitive tests are expected to take approximately 60 minutes to complete. Participants will be instructed to complete the questionnaires and cognitive tests within two weeks of signing the consent form. The onscreen instructions and consent form will also notify participants that a) they do not have to complete either the questionnaires or the cognitive tests in one sitting, but can return to them during the course of the week, and b) they can move back and forth between the questionnaires and cognitive tests (i.e., do not need to finish one section before moving to the next). Reminder emails will be sent on days 7 and 10 to remind participants to complete assessments.

A subset of participants who volunteer to do so will also wear an accelerometer for 24 hours per day for 7 consecutive days to objectively measure activity levels and sleep quality. Individuals will be asked if they are willing to be contacted to wear the accelerometer via the consent form. Only those individuals who check the box agreeing to be contacted by the research team will be contacted to wear the accelerometer (see consent form). Participants will be contacted via email and instructed to reply to the researcher by phone or email with their mailing address. The accelerometer, instructions for wear, a Record of Use form, and a postage-paid return envelope will be mailed to participants who agree to wear the monitor. Mailing labels from postage-paid return envelopes will be disposed of after accelerometers have been returned and recorded. The accelerometer will be worn during women's daily life on a normal week; therefore, minimal additional time committed to research activities will be required of participants. No contact will be solicited with participants over the course of the 6-month study period.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female breast cancer patients and survivors aged 21 years or older and who have access to an iPad (iOS 6.2 or later) and the Internet.
Criteria

Inclusion Criteria:

  • Female diagnosed with breast cancer
  • 21 years or older
  • English speaking
  • Access to an iPad with iOS 6.2 or later and the Internet

Exclusion Criteria:

  • Male
  • Individuals under 21 years of age
  • Individuals who do not have access to an iPad with iOS 6.2 or later
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02523677

Locations
United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Edward McAuley, PhD University of Illinois Urbana-Champaign
  More Information

Additional Information:
Publications:
Lachman ME, Bandura M, Weaver SL, Elliott E. Assessing memory control beliefs: The Memory Controllability Inventory. Aging Cogn 2(1):67-84, 1995.
Eriksen BA, Eriksen CW. Effects of noise letters upon identification of a target letter in a non-search task. Perception and Psychophysics. 16:143-149, 1974.

Responsible Party: Edward McAuley, Shahid and Ann Carlson Khan Professor in Applied Health Sciences, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02523677     History of Changes
Other Study ID Numbers: UIUC_IRB_15666
Study First Received: August 10, 2015
Last Updated: November 1, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2017