E7-24872. Proposed Collection; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI)

SUMMARY:

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 National Cancer Institute (NCI) of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection

Title: Cancer Care For Uninsured Individuals: A Feasibility Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of this information collection is to conduct a pilot study to assess the feasibility of obtaining health insurance information for participants of the Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial participants from health care providers and self reports. The ultimate objective is to compare the health care utilization of insured and uninsured PLCO participants. The PLCO data provides a unique opportunity to study health care seeking behavior after an abnormal cancer screening test and the effect of lack of health insurance. Individuals randomized to the intervention arm of the trial received screening for the PLCO cancers. Individuals with positive findings were referred to their doctors for follow-up care, but no additional care was provided by the trial. The PLCO study then collected detailed information on tests received for diagnosis, clinical presentation of disease, and cancer treatment. Since the PLCO original data collection had not recorded the health insurance of participants at the time of their screening, it is necessary to collect it retrospectively. This feasibility study will request information from 50 physicians and 150 participants. The aims are to determine:

(1) The total number of physicians to be contacted to obtain insurance information on all PLCO participants who had a positive cancer screening test;

(2) The percentage of physicians willing and able to provide insurance information;

(3) The percentage of respondents' patients with and without insurance, and possibly distribution of patients by insurance type;

(4) The number of participants for whom the insurance status can be only determined by self report;

(5) The percentage of PLCO participants who are willing to respond to the survey;

(6) The percentage of individuals who are willing to provide information on insurance status and type; and,

(7) The potential proportion of PLCO participants without health insurance at the time of screening.

The results of this feasibility study will be used to design of a larger study to examine the health care behavior of insured and uninsured PLPCO participants. This is relevant to understand the results of the PLCO Cancer Screening Trial and other screening trials currently being conducted in the U.S. The success of these trials is conditional on participants' access to care following a recommendation for follow-up. Uninsured individuals may be more likely to join these trials than insured ones in order to get free preventive care. They may also be more likely to not seek, or delay seeking, care after an abnormal screening test even though they are encouraged to get care and they may be highly motivated to receive the best care possible. It is relevant for other decision makers to understand whether uninsured persons are receiving appropriate care after abnormal screening results. The efforts to control cancer disease and the loss of life associated with it are concentrated on population wide screening. These endeavors may be compromised if a significant proportion of the population does not get appropriate follow-up after screening or does not get the care known to be effective for their disease.

Frequency of Response: One time. Affected Public: Individuals or households; Businesses or other for-profit. Type of Respondents: Men and women older than 55 who participated in the PLCO Screening trial and physicians who provided care for them. The annual reporting burden is shown in the following table.

Type of respondents	Number of respondents	Frequency of response	Average burden hours per response	Annual hour burden
PLCO participants	150	1	5 minutes (0.08)	12.5
Physicians office staff	50	1	20 minutes (0.33)	16.7
Totals	200			29.2

The annualized cost to respondents is estimated at: $488. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Maria Pisu, Division of Preventive Medicine, University of Alabama at Birmingham, MT 628, 1530 3rd Avenue South, Birmingham, AL 35294-4410, or call non-toll-free number [phone] or e-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.

Dated: December 11, 2007.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.