E6-6710. Proposed Collection; Comment Request; CERTAS: A Researcher Configurable Self-Monitoring System

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment proposed data collection projects, the National Cancer Institute (NCI) and 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: CERTAS: A Researcher Configurable Self-Monitoring System.

Type of Information Collection Request: NEW.

Need and Use of Information Collection: This study seeks to further our understanding of the usefulness and potential advantages of electronic self-monitoring of behavior-specifically diet and exercise behaviors associated with reduction of cancer risks. Logs, diaries, checklists and other self-monitoring tools are an ubiquitous part of nearly all cancer control research. The primary objective of this study trial is to compare paper-based self-monitoring to CERTAS self-monitoring devices (wireless sync and local sync) in a range of cancer risk behaviors. The findings will provide valuable information regarding: (1) A comparison of the real time recording compliance of these methods, (2) the pre-post effects of each type of recording (paper versus electronic), and (3) the relative cost per valid recorded entry for the two methods.

Frequency of Response: Daily.

Affected Public: Individuals.

Type of Respondents: Males and females 18 years of age or older who are: (1) Interested in improving their diet and exercise behaviors as they relate to cancer prevention, (2) proficient in utilizing a computer, and (3) generally healthy with no medical conditions which would require a special diet or preclude regular exercise. The present study includes pre-post tests and a four week comparative trial. The pre-post tests involve the completion of self-administered questionnaires on diet and physical activity as well as body measurements (i.e. height, weight, waist, hips). The pre-test visit will also include a review of the study information and informed consent. A usability interview of the self-monitoring method will conclude the post-test. The two office visits for the pre-post tests will take approximately one hour per visit. The four week comparative trial has a total of one-hundred and twelve possible responses (4 responses per 28 days; about 8 minutes per day).

The annual reporting burden is as follows:

Estimated Number of Respondents: 200.

Estimated Number of Responses per Respondent: 3.

Average Burden Hours Per Response: 1.9, and

Estimated Total Annual Burden Hours Requested: 1,148. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Estimates of Hour Burden

Respondent type	Number of respondents	Frequency of response	Average time per response	Annual hour burden
Male	80	3	1.9134	459.264
Female	120	3	1.9134	688.896
Total	200			1,148.16

Hour Burden Estimates By Form

Type of form	Number of items	Frequency of response	Average time per form	Aggregate hour burden
GSEL	28	2	.5	1.0
Physical Activity	3	2	.0835	.167
Self-Monitoring	15	1	3.7408	3.740
*Additional Pre-test Items		1	.4175	.417
**Additional Post-test Items		1	.4175	.417
Total				5.74
*Includes study briefing, demographics, consent form, body measurements.
**Includes body measurements and usability interview.

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, electric, 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. Jami Obermayer, Principal Investigator, PICS, Inc., 12007 Sunrise Valley Drive, Suite 480 Reston, Virginia 20191 at [phone] or e-mail your request, including your address to [e-mail].

Commments 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: April 27, 2006.

Rachelle Ragland-Greene,

National Institutes of Health, NCI Project Clearance Liaison.