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On-line Participant Consent Form

Relationships among Cognitive Function, Lifestyle, and Exercise after Cancer Treatment (ReFLECT)

You have expressed an interest in participating in a research study. This research study is being conducted by Professor Edward McAuley of the Department of Kinesiology and Community Health from the University of Illinois Urbana Champaign. If you agree to participate in this study, you will be asked to electronically sign this informed consent. Informed consent is an agreement that you, or your authorized representative, sign indicating a willingness to participate in this research. This informative document will tell you about the purpose, risks, and benefits of this research study. You should consent only after you have been given all the necessary information and have had enough time to decide whether you wish to participate. Your decision to participate or decline participation in this study is completely voluntary and you have the right to terminate your participation at any time without penalty. You may skip any questions you do not wish to answer. If you want do not wish to participate in this study, simply close the application.

Study Description

This study is designed to examine cognitive function, physical activity, sleep quality, and quality of life in breast cancer patients and survivors. To be considered as a possible participant in this research study, you must be a female who has access to an iPhone and the Internet, is aged 21 years or older, self-identify as a racial or ethnic minority, such as but not limited to African American, Hispanic/Latina, Asian, American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or more than one race has been diagnosed with breast cancer, and is comfortable reading and writing in English. Women with a breast cancer diagnosis who have not undergone treatment, are currently undergoing treatment, or who have completed treatment are eligible to participate in this study.

Assessments

You will be asked to download the ReFLECT+ iPhone application supported by BrainBaseline© and designed specifically for this study to complete the following assessments:

All surveys and cognitive tests should be completed within two weeks of signing this consent form. You may receive one or more reminder emails or notifications from BrainBaseline© on your iPhone to complete the surveys and cognitive tests. All assessments will be collected at one time-point. Each activity should take no more than two to five minutes. The entire survey battery should take a total of approximately 45 minutes, and the entire test battery should take 30 minutes. You can complete the surveys and cognitive tests in any order at any time that is convenient for you. You do not need to complete all the activities in one session. All participants will be offered individualized feedback on their physical activity levels and cognitive performance at the end of the study.

Risks

As the surveys assess general health and breast cancer history, health behaviors, and current symptoms, there is a remote possibility that responding to some items may be unsettling for some individuals. However, we do not believe that completion of these surveys poses any significant risk to participants’ well-being or emotional health. You may refuse to answer any questions that make you feel uncomfortable. Your participation will contribute to our understanding of relationships among lifestyle behaviors, cognitive function, and quality of life in breast cancer patients and survivors. Such information will allow us to better design interventions and programs for this population. Your participation in this research will be completely confidential and data will be averaged and reported in aggregate. Data collected in this study may be disseminated through journal articles or presentations at professional conferences.

Benefits

This study may or may not have direct benefits for you. However, we hope the information gained from this study will benefit other patients with breast cancer in the future.

Remuneration

As an incentive, and in appreciation for contributing your time to this study, all participants who complete surveys and cognitive tests, and wear the accelerometer will receive a $25 gift card at the completion of the study.

Costs

There is no cost to you to participate in this study.

Privacy and rights

Will my study-related information be kept confidential?

Yes, but not always. In general, we will not tell anyone any information about you. When this research is discussed or published, no one will know that you were in the study. However, laws and university rules might require us to disclose information about you. For example, if required by laws or University Policy, study information which identifies you and the consent form signed by you may be seen or copied by the following people or groups:

Data collected through the BrainBaseline© application are stored and transferred using industry-standard encryption and security protocols. All data collected will be numerically coded and aggregated. All data files will be stored on a password protected network that will have access limited to research personnel. Your personal information may be given out if required by law as stated above. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

Participation in this project is voluntary and you are free to withdraw your participation without penalty at any time. Additionally, the investigators may contact you in the future regarding other research conducted by this research team. You may opt out of these communications and opportunities at any time.

Contact information

If you have questions at any time during your participation in this study, please feel free to contact us at reflect-studies@illinois.edu. You can also contact Professor Edward McAuley, Department of Kinesiology and Community Health, University of Illinois at 217-333-6487 or Susan Aguiñaga (postdoctoral researcher) at 217-300-4700. You may also visit our website at www.reflectstudies.org for more information. Should you have further questions about your rights as a research participant, please contact the University of Illinois Institutional Review Board by email at irb@illinois.edu or by phone at 217-333-2670. You may save a copy of this consent form for your records, if you so desire.


I have read and understand the informed consent provided by Professor Edward McAuley. I agree to the procedures outlined above and willingly consent to be a participant in this study. I state that I am 21 years of age or older and meet all of the eligibility criteria as defined on this consent form and at www.reflectstudies.org. Please select one of the options below: