Clinical trial: NCT04533763
Section: Alternatives
Subsections: What Other Treatment Options Are There?

Before you decide whether or not to be in this study, you may discuss with your doctor other options that are available to you. Instead of being in this study, you could participate in other online stress management or lifestyle studies or programs.
Clinical trial: NCT04533763
Section: Confidentiality
Subsections: Hipaa Information (See Also The Will My Health Information Be Used **Section):**|Certificate Of Confidentiality|Will My Health Information Be Used During This Study? The Federal Health Insurance Portability And Accountability Act (Hipaa) Requires Your Health Care

We would like to contact your gynecologic oncologist or oncology provider for medical records to verify specific medical information. The information we will request from your oncology provider(s) will include your initial diagnostic and surgical report, pathology report, medical and surgical history, and clinic notes. This consent authorizes us to contact your oncology provider(s) for your medical records. Information from your current medical record, (e.g. your diagnosis, cancer stage, treatment, height, weight, medical history) may be used as part of the study. We may also contact your oncology provider(s) periodically, in the future, to follow up on your medical/survival status (as explained in the previous paragraph). Current and past mental health diagnoses are used as part of the screening for the study but following screening, this information is not used as part of the study. Information from the study other than your participation in the study will not be added to your medical record.

To further help us protect your privacy, we have obtained a Certificate of Confidentiality from the federal government. This certificate means the researchers cannot be required to tell people who are not connected with the study, including the courts, about your participation, without your written consent. Unless you give permission, the study team can only disclose information about you if you or someone else is in serious danger of harm. The University of Iowa Hospitals and Clinics generally requires that we document your participation in research occurring in a University of Iowa Health Care facility. This documentation will be in either your medical record or a database maintained on behalf of the institution reflecting that you are participating in this study. The information included 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. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. A copy of the informed consent document will be available on this website. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

provider 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 and for your study treatment. Once your health care provider 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, the University of Iowa Institutional Review Boards and support staff, and colleagues at other institutions who are involved in this 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 your health care provider 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 your health care provider. 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. Susan Lutgendorf, G60 Psychological and Brain Sciences Building, University of Iowa, 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.
Clinical trial: NCT04533763
Section: Duration of Study Involvement
Subsections: How Long Will I Be In **This Study?**

If you agree to take part in this study, your involvement will last for 12 months. There will be an introductory phone call (15-30 minutes), a brief practice on use of the study website and web conferencing (15-30 minutes), an orientation session, 10 weekly group sessions, and 2 follow-up group sessions. Each group session will last approximately 1.5 to 2 hours. All sessions will take place in your home or another secure location using web-based conferencing. You will also be asked to complete surveys before and after the 10-week program, and at 6 months and 12 months following the program. Surveys will take approximately 30-45 minutes to complete.
Clinical trial: NCT04533763
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks 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. Potential risks of the study include the possibility that you may be uncomfortable answering specific questions on surveys; you may experience minor discomfort from discussing potentially distressing topics in the group, and there is a potential loss of confidentiality from using web conferencing with other cancer survivors. These risks will be minimized by the following procedures: all group members will be instructed on procedures to protect confidentiality at the beginning of the group sessions; you are free to not answer specific questions on study surveys, and you can choose how much information you share about yourself in group discussions.
Clinical trial: NCT04533763
Section: Procedures
Subsections: What Will Happen During This Study?

If you agree to participate in this study, you will be randomly assigned to receive either the Mindful living or Healthy Lifestyles study programs. This means that whichever study intervention 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 intervention programs.  
For both programs, your involvement will include
- an introductory phone call to make sure you can operate the web site on the tablet or on your home computer and a follow-up practice with the study website and web conferencing.  
- an orientation session to make sure you can connect to the group by web
- group meetings by web for 10 weeks that will take approximately 1½ to 2 hours per week. - Follow-up group sessions approximately 4.5 months and 9 months after the start of the program
(approximately 1-1½ hours)
- Completing surveys on mood, quality of life, coping, and health behaviors before and after the 10-week program, and at 6 months and 12 months after the start of the program.
The *Mindful Living* sessions will involve topics such as coping with ovarian cancer, stress management, maximizing support from friends and family, living with an ovarian cancer diagnosis, relaxation and meditation techniques, spirituality, and imagery. The *Healthy Lifestyles* sessions will include topics such as exercise, sleep, nutrition, cognitive function, stress management, and survivorship. If you don't have a laptop or tablet with a camera, we will send you a tablet or webcam by FedEx or UPS. If you do not have internet access at home, we can send you a tablet with internet connectivity. We will also send you a manual with instructions for website use and a workbook for your group. We will give you instructions on how to access the study website, the web conferencing system, and instructions on how to complete questionnaires and play relaxation recordings. You will have at least one individual practice session with a member of the research team to make sure you feel comfortable using web-conferencing.  
Before the program starts, we will schedule a group orientation session so that you can meet the other people in the group and learn exactly what the program will involve. We will schedule the groups to try to be convenient for participant schedules. In the *Mindful Living* program, in addition to the web sessions, you will be requested to practice the relaxation and meditation techniques that you learn in the program and to keep a short daily record of meaningful moments. If we send you a tablet or webcam, you will need to return the tablet or webcam to the research team at the University of Iowa by pre-paid FedEx or UPS when the program is finished. If you have an iPad, laptop, or tablet at home, you may be able to use your own device. As with any research, you are free to not answer any questions you would prefer not to answer. By participating in this study, you agree to not download study videos and share them outside the study.  
  
As part of this study, the study team will also be reviewing your medical/survivorship status in the future. This may include contacting you directly, contacting your oncology provider(s) or using publicly available search engines (if we cannot reach you or your oncologist).  
Study Timepoints  
Activity E  
N  
  
| Study Timepoints            |                          |                                      |        |            |         |        |      |         |       |
|-----------------------------|--------------------------|--------------------------------------|--------|------------|---------|--------|------|---------|-------|
| N  R  O  L  L  M  E  N  T   | PreGroup                          | R A  N  D  O  M  I  Z  A  T  I  O  N | Week 0 | Weeks 1-11 | Week 12 | 4.5 mo | 6 mo | 9-10 mo | 12 mo |
| (Post)                      | F/U                      | F/U                                  |        |            |         |        |      |         |       |
| Surveys                     | X                        | X                                    | X      | X          |         |        |      |         |       |
| X                           | X                        | Group                                |        |            |         |        |      |         |       |
| orientation  & 10  sessions | Follow-up  Group session | Followup group  session                                      |        |            |         |        |      |         |       |  
Intervention  
Group  
orientation  
& 10  
sessions
Clinical trial: NCT04533763
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 have completed treatment for ovarian cancer within the last 3 years. The purpose of this research study is to compare the effectiveness of two different kinds of intervention programs specifically designed for ovarian cancer survivors to help improve quality of life and well-being, and to decrease distress. The programs will be delivered in a group format using web-conferencing, and participants can access the programs from their homes. We will compare the effects of a stress management and coping program (Mindful Living) with a program promoting healthy lifestyles (Healthy Lifestyles) on quality of life, distress, and well-being. The significance of this research is that we hope it will provide information and effective tools for ovarian cancer survivors to improve quality of life and well-being. Other goals are to increase connectedness and decrease isolation among ovarian cancer survivors.
Clinical trial: NCT04533763
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: NCT04533763
Section: Withdrawal from Study
Subsections: What If I Decide To Drop Out Of The Study?|Can Someone Else End My Participation In This Study?

If you decide to leave the study early, you are free to do so. We will ask you to let us know that you are leaving the study and to return any study equipment (tablet, webcam, headphones) if you have them. We will also ask you to complete the remaining study surveys if you are willing to do so.

Under certain circumstances, the researchers or NIH might decide to end your participation in this research study earlier than planned. This might happen because the study funding ends.