Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Evaluation of an Online Prostate Cancer Decision Aid” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on January 26, 2024 to obtain comments from the public and affected agencies. CDC received two comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain . Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Evaluation of an Online Prostate Cancer Decision Aid—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC), Division of Cancer Prevention and Control (DCPC) is requesting a new, three-year OMB approval to conduct a three-arm, randomized controlled trial (RCT) to evaluate the impact of a virtual human decision aid to help improve the quality of prostate cancer screening and treatment decisions. Talk to Nathan About Prostate Cancer Screening (hereafter referred to as Nathan) is DCPC's online, interactive, human simulation decision aid designed to help men learn and make informed decisions about prostate cancer screening. A small, preliminary evaluation of Nathan showed promise in increasing men's knowledge about prostate cancer and likelihood of engaging in shared decision-making about prostate cancer screening with their health care providers. At this time, a larger, more systematic evaluation can help to understand whether Nathan is effective in areas such as improving knowledge, overcoming health literacy barriers, and resolving decisional conflict, especially among priority populations who are most likely to be affected by prostate cancer and least likely to be screened. Further, as some experts consider the digital divide to be the newest social determinant of health, it is important to explore how, where, and for which populations there may be disparities in accessing and using Nathan.

Broadly, the purpose of this information collection is to: (1) assess whether Nathan is more effective at helping men make decisions about prostate cancer screening than an established decision aid or standard educational materials; (2) determine if changes or improvements to Nathan are warranted; and (3) identify ways to incorporate Nathan into primary care. We will select four primary care clinics to participate in this study. The RCT includes a three-group parallel design with one treatment arm and two control arms to test the effectiveness of Nathan for men aged 55-69. We will recruit 900 men aged 55-69 who have an upcoming general health exam at one of the four primary care clinics and randomize them to one of three arms: (1) Nathan (intervention = 300 men); (2) the Massachusetts Department of Public Health's (MDPH's) Patient Decision Aid, Get the Latest Facts about Screening for Prostate Cancer (control 1 = 300 men); and (3) standard educational materials from the National Cancer Institute (NCI), Prostate Cancer Screening (PDQ®)—Patient Version (control 2 = 300 men).

Eight forms of information collection will be implemented to answer our evaluation questions. These include a provider survey; a patient eligibility screener; patient pre-exposure, post-exposure, and post-clinic visit surveys; a patient usability survey; patient user experience interviews; and clinic coordinator interviews. Each instrument will be administered once per respondent throughout the course of the study. The provider survey and clinic coordinator interviews will be conducted in English only. All other information collections will be conducted in English or Spanish. The total response burden is estimated to be 1,129 hours. There are no costs to respondents other than their time to participate in data collection activities.