PURPOSE OF THE STUDY

To evaluate how well we can reach out to men with new localized prostate cancer through the North Carolina Cancer Registry and provide a way to help with treatment decisions.

VOLUNTEERING FOR THIS STUDY

You do not have to use this website program or participate in a follow up telephone interview, it is voluntary. Quitting at any time is allowed.

STUDY PROCEDURES

If you continue in this website, you will see a one-time questionnaire plus teaching and coaching topics that have been shown in previous research to help men with making a prostate cancer treatment decision. Using the website takes about 15-30 minutes. You will not be compensated for using the website.

Sixty of the men who agree to these terms will be contacted by the study team to participate in an audio-recorded telephone interview about your experience using the program. The study team will not view any of your questionnaire answers prior to speaking with you. The interview will take about 30-60 minutes depending on how much you wish to share. If you begin the interview, you will be compensated $50 for your time.

BENEFITS

Previous research studies in men of all races in the US have shown that using the program resulted in lower conflict associated with making a treatment decision. Also, previous research showed that Black men who used the program reported lower regret after making a treatment decision.

There is no benefit to you from the telephone interview, but your feedback may help men in the future.

RISKS, STRESS, OR DISCOMFORT

Some questionnaire items may make you feel uncomfortable (such as questions about sexual activity or feeling depressed). You may skip these questions if you wish.

SECURITY

The University of Washington’s computer servers have many safeguards to prevent un authorized access to our data bases. Please do not share your password with anyone else to keep your data secure.

CONFIDENTIALITY OF RESEARCH INFORMATION

Your answers will be kept in a separate data base from your name. If you choose to print a summary of your answers to give your doctor, your name will appear on the form.

We have a Certificate of Confidentiality from the federal National Institutes of Health. This helps us protect your privacy. The Certificate means that we do not have to give out information, documents, or samples that could identify you even if we are asked to by a court of law. We will use the Certificate to resist any demands for identifying information.

We can’t use the Certificate to withhold your research information if you give your written consent to give it to an insurer, employer, or other person. Also, you or a member of your family can share information about yourself or your part in this research if you wish.

There are some limits to this protection. We will voluntarily provide the information to:

• a member of the federal government who needs it in order to audit or evaluate the research;
• individuals at the institution(s) conducting the research, the funding agency, and other groups involved in the research, if they need the information to make sure the research is being done correctly;
• the federal Food and Drug Administration (FDA), if required by the FDA;
• individuals who want to conduct secondary research if allowed by federal regulations and according to your consent for future research use as described in this form;
• authorities, if we learn of child abuse, elder abuse, or the intent to harm yourself or others.

The Certificate expires when the NIH funding for this study ends. Currently this is January 1, 2024. Any data collected after expiration is not protected as described above. Data collected prior to expiration will continue to be protected.

FUTURE RESEARCH

The data base of answers does not include your name or any other information that could identify you. We, or our colleagues, may analyze the data set for new research questions in the future.

RESEARCHERS

Co-Principal Investigator: Dr. Donna Berry, Professor, Biobehavioral Nursing and Health Informatics, University of Washington; 206-616-9396

Co-Principal Investigator: Dr. Ronald Chen, Professor and Chair, Department of Radiation Oncology, University of Kansas Cancer Center; 913-588-1617

Co-investigator: Dr. Chandrika Rao, Director, Central Cancer Registry | State Center for Health Statistics North Carolina Department of Health and Human Services; 919-792-5946

Funding

This program and study are funded by the National Institute of Nursing Research at the National Institutes of Health.