Breast CancerReFLECTNCT02523677
Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment
An observational study of Breast Cancer and Cognitive Impairment, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Cognitive Impairment
- How many people
- 456 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female breast cancer patients and survivors aged 21 years or older and who have access to an iPad and the Internet.
Who may be able to join
- Female diagnosed with breast cancer
- 21 years or older
- English speaking
- Access to an iPad with iOS 6.2 or later and the Internet
Who cannot join
- Male
- Individuals under 21 years of age
- Individuals who do not have access to an iPad with iOS 6.2 or later
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Cognitive Impairment
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months
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
Measured: Baseline, 6 months
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
Measured: Baseline, 6 months
Secondary outcomes (3)
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.
Measured: Baseline, 6 months
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.
Measured: Baseline, 6 months
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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward McAuley, University of Illinois at Urbana-Champaign
- Investigators
- Edward McAuley, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523677
- Sponsor's protocol ID
- UIUC_IRB_15666
- Acronym
- ReFLECT
- Status last verified
- Oct 2017
- First submitted
- 10 Aug 2015
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 4053261Marshall 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.
PubMed 19997030Visser 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.
PubMed 23899190Buysse 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. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Brady 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. doi: 10.1200/JCO.1997.15.3.974.
PubMed 9060536Webster 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. doi: 10.1186/1477-7525-1-79.
PubMed 14678568Yellen 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. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Lachman ME, Bandura M, Weaver SL, Elliott E. Assessing memory control beliefs: The Memory Controllability Inventory. Aging Cogn 2(1):67-84, 1995.
Zelinski EM, Gilewski MJ. A 10-item Rasch modeled memory self-efficacy scale. Aging Ment Health. 2004 Jul;8(4):293-306. doi: 10.1080/13607860410001709665.
PubMed 15370046Eriksen 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.
Awh E, Jonides J, Reuter-Lorenz PA. Rehearsal in spatial working memory. J Exp Psychol Hum Percept Perform. 1998 Jun;24(3):780-90. doi: 10.1037//0096-1523.24.3.780.
PubMed 9627416KIRCHNER WK. Age differences in short-term retention of rapidly changing information. J Exp Psychol. 1958 Apr;55(4):352-8. doi: 10.1037/h0043688. No abstract available.
PubMed 13539317Basner M, Dinges DF. Maximizing sensitivity of the psychomotor vigilance test (PVT) to sleep loss. Sleep. 2011 May 1;34(5):581-91. doi: 10.1093/sleep/34.5.581.
PubMed 21532951
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment
- ClinicalTrials.gov ID
- NCT02523677
- Acronym / sponsor ID
- ReFLECT / UIUC_IRB_15666
- Conditions
- Breast Cancer, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patients and survivors aged 21 years or older and who have access to an iPad and the Internet.
Key inclusion criteria (4 listed)
- Female diagnosed with breast cancer
- 21 years or older
- English speaking
- Access to an iPad with iOS 6.2 or later and the Internet
Key exclusion criteria (3 listed)
- Male
- Individuals under 21 years of age
- Individuals who do not have access to an iPad with iOS 6.2 or later
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Medical Health History
Time frame: Baseline, 6 months
Change in Sleep Quality (objectively measured)
Time frame: Baseline, 6 months
Change in Physical Activity (objectively measured)
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 19997030Marshall 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.
- Background: PubMed 23899190Visser 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.
- Background: PubMed 2748771Buysse 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. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 9060536Brady 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. doi: 10.1200/JCO.1997.15.3.974.
- Background: PubMed 14678568Webster 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. doi: 10.1186/1477-7525-1-79.
- Background: PubMed 9095563Yellen 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. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- BackgroundLachman ME, Bandura M, Weaver SL, Elliott E. Assessing memory control beliefs: The Memory Controllability Inventory. Aging Cogn 2(1):67-84, 1995.
- Background: PubMed 15370046Zelinski EM, Gilewski MJ. A 10-item Rasch modeled memory self-efficacy scale. Aging Ment Health. 2004 Jul;8(4):293-306. doi: 10.1080/13607860410001709665.
- BackgroundEriksen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward McAuley, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cognitive Impairment, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function (time frame: Baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523677, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.