Clinical trial: NCT03687970
Section: Confidentiality
Subsections: Breach Of Confidentiality|Are There Additional Protections For My Health Information? Protected Health Information (Phi) Is Health Information That Identifies You. Phi Is Protected By Federal

One risk of participating in this study is that confidential information about you may be accidentally disclosed. We will use our best efforts to keep the information about you secure. Please see the section in this consent form titled *"How will you keep my information confidential?"* for more information.

law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this research, you must give the research team permission to use and disclose (share) your PHI for the study as explained in this consent form. The research team will follow state and federal laws and may share your health information with the agencies and people listed under the previous section titled, "How will you keep my information confidential?" Once your health information is shared with someone outside of the research team, it may no longer be protected by HIPAA. The research team will only use and share your information as talked about in this form or as permitted or required by law. When possible, the research team will make sure information cannot be linked to you (de-identified). Once information is de-identified, it may be used and shared for other purposes not discussed in this consent form. If you have questions or concerns about your privacy and the use of your PHI, please contact the University's Privacy Officer at 866-747-4975.  
Although you will not be allowed to see the study information, you may be given access to your health care records by contacting your health care provider.
Clinical trial: NCT03687970
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?|Potential Risks From Thermal Testing|Potential Risks From Dlss|Women Capable Of Becoming Pregnant|What If I Am Injured As A Result Of This Study?

You may experience one or more of the risks indicated below from being in this study. In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.  
  
  
  
APPROVAL DATE: 04/02/21 RELEASED DATE: 04/02/21 EXPIRATION DATE: 04/01/22
Likely / Common Mild
- Temporary pain Less Likely / Less Common Mild
- Risk of mild skin burn Rare Serious
- Risk of small but serious skin burn

Risk of injury from thermal pain testing is low. Thermal testing does produce low level pain, but the pain is temporary in nature and generally stops after the test and the pain you will experience is expected to be below your tolerance level. Additionally, you may stop any test at any time. With thermal stimulation there is a very slight risk of a burn, but this is risk has been lessened by keeping the heat at or below 125.6°F, which feels like the temperature of a hot tub and the testing device has built in a shutdown system to prevent the temperature from rising above 125.6°F.

There is a low risk of skin injury or burning by laser stimulation when used for pain testing, that occurs by overheating of skin surface. This laser irradiation penetrates the skin fairly deeply, and does not allow overheating of the skin's surface. We also use a short, concentrated pulse; this will activate nerve fiber but is not long enough in duration to cause tissue damage.

You may not participate in this study if you are pregnant. If you are a woman capable of becoming pregnant, we will perform a pregnancy test before beginning this study. Questionnaires and Assessments Completing the questionnaires or assessments may cause emotional discomfort, boredom, or fatigue. You have the right, however, to refuse to answer any question for any reason.

Washington University investigators and staff will try to reduce, control, and treat any complications from this research. If you feel you are injured because of the study, please contact the investigator, Simon Haroutounian, at 314-286-1715 and/or the Human Research Protection Office at 1-(800)-4380445. Decisions about whether payment for medical treatment for injuries relating to your participation in research will be made by Washington University. If you need to seek medical care for a research-related injury, please notify the investigator as soon as possible.  
HOW WILL YOU KEEP MY INFORMATION **CONFIDENTIAL?** Other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.  
- Government representatives (including the Office for Human Research Protections) to complete federal or state responsibilities
- The U.S. Food and Drug Administration - National Institutes of Health (NIH)
- LasMed, LLC
- Hospital or University representatives to complete Hospital or University responsibilities
- Information about your participation in this study may be documented in your health care records and will be available to anyone with access to your health care record, including your health insurance company. This information may also be released as part of a release of information request.  
- The last four digits of your social security number may be used in hospital or University systems  
  
  
to track billing information for research procedures.  
- Washington University's Institutional Review Board (a committee that oversees the conduct of research involving human participants) and the Human Research Protection Office. The Institutional Review Board has reviewed and approved this study.  
The research team will send study results to LasMed, LLC. Information sent to LasMed, LLC will be de-identified. LasMed, LLC will use this information to study the effectiveness of the device. In the future, LasMed, LLC may continue to use your health information that is collected as part of this study. For example, LasMed, LLC may combine information from this study with the results of other studies to re-analyze the safety and effectiveness of the study device, to evaluate other products or therapies, to develop a better understanding of a disease, or to improve the design of future research studies. LasMed, LLC may also share information from the study with regulatory agencies in foreign countries. If you receive Medicare benefits, are injured as part of your participation in this research study and medical treatment relating to this injury is paid by anyone other than you or your insurance company, that payer will need to collect personal information about you. This information includes your name, date of birth, gender, social security number, Medicare identification number and information related to this research study. The payer will report this information to the Centers for Medicare & Medicaid Services (CMS), the federal agency that oversees the Medicare program, during your participation in the study and for as long as the payer is required by CMS to report this information. If you do not want to release your personal or treatment related information you have the right to refuse reimbursement by the payer for any research injury. The payer will not use this information for any other purpose. The Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital is supported by funding from the National Cancer Institute (NCI). To meet NCI requirements, your protected health information relating to your participation in this study (including your social security number) will be stored in a secure database at the Siteman Cancer Center. This database and also your health care records may be reviewed by Siteman Cancer Center personnel. All information will be securely and confidentially maintained. To help protect your confidentiality, you will be assigned a study ID number and we will use that ID to manage all your study related information. This includes paper documents and electronic documents that we collect from you during your participation. Additionally, the key to the ID code linking code numbers to names will be kept at a separate location, under lock and key, and only the research team will have access to it. We will destroy the link between your ID and your identifiers at the end of the study. Any report or article that we write will not include information that can directly identify you. The journals that publish these reports or articles require that we share your information that was collected for this study with others. Sharing this information will allow others to make sure the results of this study are correct and help develop new ideas for research. Your information will be shared in a way that cannot directly identify you. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. To further protect your privacy, this research is covered by a Certificate of Confidentiality from the  
  
  
federal government. This means that the researchers can refuse to disclose information that may identify you in any legal or court proceeding or to anyone who is not connected with the research except if:
- there is a law that requires disclosure, such as to report child abuse and neglect, or harm to self or others;
- you give permission to disclose your information, including as described in this consent form; or
- it is used for other scientific research allowed by federal law.  
You have the right to share your information or involvement in this study with anyone at any time. You may also give the research team permission to disclose your information to a third party or any other person not connected with the research. If information about you or your involvement in this research is placed in your medical record the information may no longer be protected under the Certificate. However, information in your medical records is protected in other ways.
Clinical trial: NCT03687970
Section: Procedures
Subsections: What Will Happen During This Study?

We may have already talked with you by phone or in person and scheduled this visit specifically to discuss the study in detail with you so you can decide whether or not to participate. If you decide to participate and give consent today, we will ask you questions about your pain conditions, your cancer diagnosis, other chronic illnesses or conditions that you have, and all the medications you take. We will also need to collect information from your medical record, such as the types of chemotherapy drugs you were given, the total amount of all doses you received, how long and how often you received chemotherapy, and the side effects that you have reported. You will be given 3 questionnaires. The questionnaires ask you about your mood and quality of life. You may skip any questions that you would prefer not to answer.  
  
  
Next, sensory testing will be performed. Sensory testing consists of multiple tests on the surface of your  
  
feet to determine your skin sensitivity to laser stimulation, warm and cold temperatures, pricking and brushing. One of these sensory tests will include the use of the DLss device. These tests (except the laser stimulation) will also be performed on your upper arm. There are automatic shut-offs in the equipment used in this testing that will prevent any injury to you. You may also tell us to stop the testing at any time. The areas of skin to be tested with the DLss device will be shaved to avoid differences in light absorption and heating (if this has not been completed already). A subset of participants may be asked to complete further sensory testing with a special imaging camera that will allow us to see redness (called cutaneous flare response) in the skin that cannot be seen with the naked eye. Five minutes after your sensory testing, we will stimulate the affected skin with the laser and then use a special imaging camera to take up to 6 pictures and video of the affected skin. We will only take images and video of the affected skin area to maintain your confidentiality. During your testing, a representative from LasMed LLC., the manufacturer of laser stimulator equipment, may be present to observe the visit and provide technical support if needed.
Clinical trial: NCT03687970
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

This is a research study. We invite you to participate in this research study because you have received one of the following chemotherapies for your cancer, oxaliplatin, cisplatin, paclitaxel, docetaxel or any combination of these, and you may or may not have pain in your feet as a result of receiving this treatment. The purpose of this research study is to test whether an investigational device [the Diode Laser fiber type Selective Stimulator (DLss)] can identify sensory changes that are unique to patients with painful chemotherapy induced peripheral neuropathy (CIPN) vs. patients who have received similar chemotherapy treatment but did not develop painful neuropathy. The confirmation of these sensory changes may lead to a new approach for early detection of CIPN. The Diode Laser fiber type Selective Stimulator (DLss) is considered investigational, which means that it has not been approved by the U.S.  
Food and Drug Administration.
Clinical trial: NCT03687970
Section: Voluntary Participation
Subsections: Is Being In This Study Voluntary?

Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time. Any data that was collected as part of your participation in the study will remain as part of the study records and cannot be removed. If you decide not to be in this study, or if you stop participating at any time, you won't be penalized or lose any benefits for which you otherwise qualify.
Clinical trial: NCT03687970
Section: Withdrawal from Study
Subsections: If You Decide Not To Sign This Form, It Will Not Affect|If You Sign This Form:|What If I Decide To Withdraw From The Study?|Can Someone Else End My Participation In This Study?

- your treatment or the care given by your health provider.  
- your insurance payment or enrollment in any health plans.  
- any benefits to which you are entitled.  
However, it will not be possible for you to take part in the study.

- You authorize the use of your PHI for this research - This authorization does not expire. - You may later change your mind and not let the research team use or share your information
(you may revoke your authorization).  
  
  
- To revoke your authorization, complete the withdrawal letter, found in the Participant section of the Human Research Protection Office website at https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the investigator send you a copy of the letter.  
o **If you revoke your authorization:**
The research team may only use and share information already collected for the study.  
Your information may still be used and shared as necessary to maintain the integrity of the research, for example, to account for a participant's withdrawal from the research study or for safety reasons.  
You will not be allowed to continue to participate in the study.

You may withdraw by telling the study team you are no longer interested in participating in the study or you may send in a withdrawal letter. A sample withdrawal letter can be found at https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research Study.

Under certain circumstances, the researchers or the study sponsor might decide to end your participation in this research study earlier than planned. This might happen for no reason or because in our judgment it would not be safe for you to continue, because your condition has become worse, because you are or became pregnant, because funding for the research study has ended.