Clinical trial NCT02523677: Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment
Official title: Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Cognitive Impairment
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 456
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 and the Internet.

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Executive Function
timeFrame: Baseline, 6 months
measure: Change in Working Memory
timeFrame: Baseline, 6 months
measure: Change in Speed of Processing
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Medical Health History
timeFrame: Baseline, 6 months
measure: Change in Sleep Quality (objectively measured)
timeFrame: Baseline, 6 months
measure: Change in Physical Activity (objectively measured)
timeFrame: Baseline, 6 months
Other outcomes:
measure: Change in Sleep Quality (self-report)
timeFrame: Baseline, 6 months
measure: Change in Physical Activity (self-report)
timeFrame: Baseline, 6 months
measure: Change in Sitting Time
timeFrame: Baseline, 6 months
measure: Change in Sedentary Activity
timeFrame: Baseline, 6 months
measure: Change in Current Symptoms
timeFrame: Baseline, 6 months
measure: Change in Fatigue
timeFrame: Baseline, 6 months
measure: Change in Anxiety and Depression
timeFrame: Baseline, 6 months
measure: Change in Quality of Life
timeFrame: Baseline, 6 months
measure: Change in Memory
timeFrame: Baseline, 6 months
measure: Change in Forgetfulness
timeFrame: Baseline, 6 months
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
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