Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment

Breast Cancer Clinical Trial

— ReFLECT  

Official title:

Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523677
• Other study ID #: UIUC_IRB_15666
• Status: Completed
• Phase: N/A
• First received: August 10, 2015
• Last updated: October 5, 2017
• Start date: July 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cognition Disorders
• Cognitive Impairment

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. — View Citation

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. — View Citation

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Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

KIRCHNER WK. Age differences in short-term retention of rapidly changing information. J Exp Psychol. 1958 Apr;55(4):352-8. — View Citation

Lachman ME, Bandura M, Weaver SL, Elliott E. Assessing memory control beliefs: The Memory Controllability Inventory. Aging Cogn 2(1):67-84, 1995.

Marshall AL, Miller YD, Burton NW, Brown WJ. Measuring total and domain-specific sitting: a study of reliability and validity. Med Sci Sports Exerc. 2010 Jun;42(6):1094-102. doi: 10.1249/MSS.0b013e3181c5ec18. — View Citation

Monsell S. Task switching. Trends Cogn Sci. 2003 Mar;7(3):134-140. — View Citation

Visser M, Koster A. Development of a questionnaire to assess sedentary time in older persons--a comparative study using accelerometry. BMC Geriatr. 2013 Jul 30;13:80. doi: 10.1186/1471-2318-13-80. — View Citation

Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79. Review. — View Citation

Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. — View Citation

Zelinski EM, Gilewski MJ. A 10-item Rasch modeled memory self-efficacy scale. Aging Ment Health. 2004 Jul;8(4):293-306. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Sleep Quality (self-report)	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.	Baseline, 6 months
Other	Change in Physical Activity (self-report)	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.	Baseline, 6 months
Other	Change in Sitting Time	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.	Baseline, 6 months
Other	Change in Sedentary Activity	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.	Baseline, 6 months
Other	Change in Current Symptoms	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.	Baseline, 6 months
Other	Change in Fatigue	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.	Baseline, 6 months
Other	Change in Anxiety and Depression	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.	Baseline, 6 months
Other	Change in Quality of Life	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.	Baseline, 6 months
Other	Change in Memory	Change in memory as measured by the Memory Controllability Inventory will be examined as an outcome of changes in sleep quality and physical activity.	Baseline, 6 months
Other	Change in Forgetfulness	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.	Baseline, 6 months
Primary	Change in Executive Function	Executive Function will be expressed as a composite score of the following cognitive tests: Flanker, Task-Switch, Trails A&B, Mazes	Baseline, 6 months
Primary	Change in Working Memory	Working Memory will be expressed as a composite score of the following cognitive tests: N-Back, Spatial Working Memory, Spatial Span, and Swap	Baseline, 6 months
Primary	Change in Speed of Processing	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	Baseline, 6 months
Secondary	Medical Health History	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.	Baseline, 6 months
Secondary	Change in Sleep Quality (objectively measured)	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.	Baseline, 6 months
Secondary	Change in Physical Activity (objectively measured)	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.	Baseline, 6 months

External Links

•   Study website