Clinical trial: NCT03801031
Section: Confidentiality
Subsections: What About Confidentiality?|Will My Health Information Be Used During This Study?

We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that 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.  
- federal government regulatory agencies, - The Iowa Cancer Consortium
- auditing departments of the University of Iowa, and
- the University of Iowa Institutional Review Board (a committee that reviews and approves research studies)  
  
To help protect your confidentiality, we will only use random study ID numbers to identify you when possible and keep any information in locked offices or secure computer systems. The ID number will not include anything that will identify you personally. If we write a report or article about this study or share the study data set with others, we will do so in such a way that you cannot be directly identified. The University of Iowa Hospitals and Clinics generally requires that we document in your medical record chart that you are participating in this study. The information included in the chart will provide contact information for the research team as well as information about the risks associated with this study. We will keep this Informed Consent Document in our research files; it will not be placed in your medical record chart.

The Federal Health Insurance Portability and Accountability Act (HIPAA) requires University of Iowa Health Care to obtain your permission for the research team to access or create "protected health information" about you for purposes of this research study. Protected health information is information that personally identifies you and relates to your past, present, or future physical or mental health condition or care. We will access or create health information about you, as described in this document, for purposes of this research study. Once University of Iowa Health Care has disclosed your protected health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but we will continue to protect your confidentiality as described under "Confidentiality." We may share your health information related to this study with other parties including federal government regulatory agencies and the University of Iowa Institutional Review Boards and support staff. The sponsor, the Iowa Cancer Consortium, may also inspect any part of your medical record for the purposes of auditing the conduct of the study. You cannot participate in this study unless you permit us to use your protected health information. If you choose not to allow us to use your protected health information, we will discuss any non-research alternatives available to you. Your decision will not affect your right to medical care that is not research-related. Your signature on this Consent Document authorizes University of Iowa Health Care to give us permission to use or create health information about you. Although you may not be allowed to see study information until after this study is over, you may be given access to your health care records by contacting University of Iowa Health Care. Your permission for us to access or create protected health information about you for purposes of this study has no expiration date. You may withdraw your permission for us to use your health information for this research study by sending a written notice to Dr. David Bender at University of Iowa Hospitals and Clinics, Department of Obstetrics and Gynecology, 200 Hawkins Drive, 31506 PFP, Iowa City, IA 52242. However, we may still use your health information that was collected before withdrawing your permission. Also, if we have sent your health information to a third party, such as the study sponsor, or we have removed your identifying information, it may not be possible to prevent its future use. You will receive a copy of this signed document.  
IRB ID \#: 201609770 APPROVAL DATE: 05/29/19 EXPIRATION DATE: 01/10/20
Clinical trial: NCT03801031
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?|Timeline:

If you agree to take part in this study, your involvement will last for up to one year. You will complete questionnaires four times during your regular visits to the gynecologic oncology clinic. The questionnaires may add about 30 minutes to your regular clinic visit.

Before your planned surgery, you will complete a set of questionnaires about your health, daily living, sexual encounters, pain, and general questions about how you are feeling. This will happen at one of your visits to the doctor's office. You will also have a physical exam that is part of your regular cancer care during these visits. Then you will have your surgery. Twelve weeks after your surgery, you will return to the doctor's office for a routine exam and to complete the same set of surveys as before your surgery. You will then be given a solution to use when you have sexual encounters that you apply to the outside of your vagina.  
The solution will either contain lidocaine (a numbing medication) or it will be a placebo and contain no active ingredient. You will be randomly assigned to receive the lidocaine or placebo. This means that whichever study treatment you receive will be determined purely by chance, like flipping a coin. You will have a 50/50 chance of receiving either of the study solutions. The placebo solution will look like the solution with the active lidocaine, so you won't know if you have the lidocaine or the placebo. Neither you nor your doctor will know what type of solution you will have while you are using it in the study, but we will be able to get this information quickly if necessary.  
To use the solution, you will soak three cotton balls in about two teaspoons of the solution. You will then hold the cotton balls on the skin just outside of your vagina for a minute before you have intercourse. You will get further detailed instructions about how to use the solution from your study doctor or the study team.  
Please do NOT use any other lubricants or aids for sexual intercourse while you are participating in this study. Twelve weeks later, you will come back to the doctor's office and complete the same set of surveys again and have a routine physical exam. You will continue to use the solution and record your pain level when you have sexual encounters. Finally, twelve weeks after this, you will return to the doctor's office for a routine physical exam and complete the same set of surveys for a fourth time. After you have completed this portion of the study and about 9 months after your surgery, your doctor  
  
can discuss with you any future recommendations about sexual health and pain management. However, you may not know which solution you received yet. All of these visits will occur at the same time as your regular cancer care follow-up visits to the doctor's office, which include physical exams, so there won't be any extra office visits necessary to be in the study. Information will be collected from your medical record to support the research study, such as your age and disease history and information from your physical examinations. We will not enter any information from the research study procedures or the questionnaires into your medical chart.
Clinical trial: NCT03801031
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of This Study?|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. The use of the numbing solution (lidocaine) can rarely cause the following allergic reaction: Itching or hives that can produce swelling in your face or hands, swelling or tingling in your mouth or throat or chest tightness (which can cause trouble breathing). Also very uncommon reactions can include: blurred or double vision; confusion, dizziness, lightheadedness, or drowsiness; chest pain, or an uneven heartbeat; skin rash; swelling in the area where this medicine is applied; and trembling (shaking). These risks could also affect your sexual partner since they may have contact with the solution. You may feel uncomfortable answering some of the questions on the surveys. You are free to skip any questions you do not want to answer. The study staff will notify appropriate personnel/authorities if you indicate thoughts of harming yourself or others.

- If you are injured or become ill from taking part in this study, medical treatment is available at the University of Iowa Hospitals and Clinics.  
- The University of Iowa does not plan to provide free medical care or payment for treatment of any illness or injury resulting from this study unless it is the direct result of proven negligence by a University employee.  
- If you experience a research-related illness or injury, you and/or your medical or hospital insurance carrier will be responsible for the cost of treatment.
Clinical trial: NCT03801031
Section: Procedures
Subsections: What Will Happen During This Study? Summary:

If you agree to participate in the study, you will complete a set of questionnaires at four time points and use a solution supplied by the research team when you have sexual intercourse. You will also keep track of your sexual encounters and pain levels during sex while you are participating in the study. The questionnaires will take about 30 minutes to complete.
Clinical trial: NCT03801031
Section: Purpose of Research
Subsections: What Is The Purpose Of This Study?

This is a research study. We are inviting you to participate in this research study because you may have gynecologic cancer. The purpose of this research study is to look at sexual functioning in cancer survivors and how it affects quality of life. Another purpose is to see if lidocaine can help with sexual-related discomfort and functioning in women who have had surgery for their cancer. Lidocaine is a medicine that helps relieve pain and is an ingredient in a lot of over-the-counter pain gels and ointments. We would like to see how it could affect any possible discomfort that a woman could experience after surgery for gynecologic cancer.
Clinical trial: NCT03801031
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. 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: NCT03801031
Section: Withdrawal from Study
Subsections: Can Someone Else End My Participation In This Study?

Under certain circumstances, the researchers might decide to end your participation in this research study earlier than planned. This might happen because you aren't following the instructions or if the solution becomes unavailable or if the study doctor feels it is best for you to discontinue.