06-2934. Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 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 35 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:

Task 1, a brief eligibility screener (5 minutes) preceding a baseline survey administered through a computer-assisted telephone interview (CATI) program. 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.

Task 2, a follow-up questionnaire will be administered, also using a CATI program, to approximately 1800 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 10 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. There are no costs to respondents except their time to participate in the survey.

Estimated Annualized Burden Table

Respondents	No. of Respondents	No. of Responses per respondent	Average burden per response (in hrs.)	Total burden (in hours)
Telephone Screener	10667	1	5/60	889
Baseline Survey (women 30 or older)	667	1	35/60	389
Follow-up Survey (completed Baseline Survey)	600	1	15/60	150
Total				1428

Dated: March 20, 2006.

Joan F. Karr,

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