E7-6583. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Risk Perception, Worry, and Use of Ovarian Cancer Screening Among Women At High, Elevated, and Average Risk of Ovarian Cancer—NEW—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Accounting for an estimated 22,220 cases and 16,210 deaths in 2005, ovarian cancer is the most frequent cause of death from gynecologic malignancy in the United States. In over 80 percent of patients, ovarian cancer presents at a late clinical stage, affording a five-year survival rate of only 28 percent. For cases where ovarian cancer is identified in Stage I, however, the five-year survival rate exceeds 90 percent.

Identifying a woman's risk of ovarian cancer plays a large role in determining the appropriateness of having her undergo screening. It is only for women with a strong family history of ovarian and/or breast cancer or women with a hereditary genetic risk for ovarian cancer that the currently available screening modalities of CA 125 and transvaginal ultrasound are recommended.

Statements from the scientific and medical community regarding recommendations for ovarian cancer screening play only a partial role in a woman's decision to undergo screening exams. Numerous psychological and sociological factors can affect this decision as well, including a woman's knowledge, attitudes, beliefs, and experiences. For instance, a woman's experience of cancer within her family or experience with a friend who has had cancer may influence a woman's screening decisions.

The literature also notes that women with a family history of ovarian cancer report increased worry and high levels of perceived risk. A positive association has also been shown between screening behavior and family history. Recent studies indicate, however, that screening is not occurring in proportion to women's levels of risk. These findings underscore the need for a better understanding of how perceived risk of ovarian cancer may influence worry about cancer and ultimately screening behavior.

To address these issues, the Division of Cancer Prevention and Control (DCPC), at the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, is conducting a study to examine the effects of family history of cancer, knowledge about ovarian cancer, worry and/or anxiety, and perceived risk of cancer on the likelihood of a woman undergoing screening for ovarian cancer. By also examining other psycho-social factors such as a woman's closeness to a relative or friend with cancer, coping style, cancer worry, use of other cancer screening tests, social support, and provider's recommendations, the study will elucidate the causal pathway leading from actual risk (as measured by family history) through perceived risk to intent to undergo screening and actual screening behavior.

The proposed study will consist of two tasks. In Task 1, a baseline survey will be administered through a computer-assisted telephone interview (CATI) program. Initially, an estimated 32,000 women will be screened to determine eligibility, and then approximately 2000 women will be asked a series of questions over a 35-minute time period. Questions will cover key variables related to ovarian cancer screening including coping, anxiety, perceived risk, worry, personal cancer history, family cancer history, closeness with family or friends who have had cancer, screening behavior, and knowledge of ovarian cancer.

In Task 2, a follow-up questionnaire will be administered, also using a CATI program, to approximately 1600 of the women included in the baseline questionnaire. Each of the women will be contacted one year after they complete the baseline survey. The researchers anticipate a 15 percent attrition of the sample between baseline and follow-up. In the follow-up, women will be asked a series of questions over a 15-minute time period. The purpose of this data collection effort is to determine if risk perception has changed and to ask about screening for ovarian cancer, since the baseline questionnaire was administered.

All data will be collected over a three-year time period. The total estimated annualized burden hours are 1,411. There are no costs to the respondents other than their time.

Estimated Annualized Burden Hours

Group	Type of respondents	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)
Eligibility Screener	Women 30 and older	10,667	1	5/60
Baseline Survey	Women 30 and older (high, elevated or average risk of ovarian cancer)	667	1	35/60
Follow-Up Survey	Women who completed the baseline survey	533	1	15/60

Dated: April 3, 2007.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.