This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 254,570 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2011. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001 and data collection continues through 2014. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. The current number of respondents in the study is 122,655; this is down from the initial total due to deaths. The primary endpoint of the trial is cancer specific mortality for each of the four cancer sites (prostate, lung, colorectal, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals.
This is a program change of the previously approved study due to OPDIV discretion; also considered a revision. Both the total number of respondents and the total burden hours have increased since the last submission due to the re-introduction of the Supplemental Questionnaire (SQX). The SQX substantially increases the average time per response. This questionnaire updates information on demographics, cancer risk factors, and history of cancer screening. The addition of a telephone script to contact respondents who do not return the ASU also contributed to the increase in respondents and burden hours.
In addition to an increase in burden, another change from the 2008 application is that the Prostate Cancer Reoccurrence Questionnaire (PCR) project will be completed under the current approval period. The PCR Questionnaire will no longer be administered and has not been included in this submission. The PCRQ is no longer being used since that data collection effort will be completed by September 29, 2011.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 1 Annual Study Update (ASU) for PLCO
Supporting Statement B_PLCO_7-8-2011.docx
Attach_15_PIA.doc
Attach_13_Sampling & Power.pdf
Annual Study Update (ASU) for PLCO