0925-0208

3-08-06

REQUEST FOR CLEARANCE FOR

COLLECTION OF DEMOGRAPHIC AND SMOKING/TOBACCO USE INFORMATION FROM NCI CANCER INFORMATION SERVICE CLIENTS

Submitted by:

Office of Cancer Information Service

National Cancer Institute

National Institutes of Health

Department of Health and Human Services

Refer questions to:

Linda Squiers

Program Officer for Research

Office of Cancer Information Service

Office of Communications

National Cancer Institute

6116 Executive Blvd., MSC 8322

Bethesda, MD 20892-8322

(301) 594-9075

FAX (301) 402-0555

E-mail: Squiersl @mail.nih.gov

TABLE OF CONTENTS

A. JUSTIFICATION 1

A.1 Circumstances Making the Collection of Information Necessary 1

A.2 Purpose and Use of the Information 5

A.3 Use of Information Technology and Burden Reduction 8

A.4 Efforts to Identify Duplication and Use Similar Information 9

A.5 Impact on Small Businesses or Other Small Entities 9

A.6 Consequences of Collecting the Information Less Frequently 10

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 10

A.8 Comments in Response to Federal Register Notice and Efforts To

Consult Outside Agency 10

A.9 Explanation of Any Payment of Gift to Respondents 11

A.10 Assurance of Confidentiality Provided to Respondents 11

A.11 Justification for Sensitive Questions 13

A.12 Estimates of Hour Burden Including Annualized Hourly Costs 14

A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record keepers 19

A.14 Annualized Cost to the Federal Government 19

A.15 Explanation for Program Changes or Adjustments 19

A.16 Plans for Tabulation and Publication and Project Time Schedule 20

A.17 Reason(s) Display of OMB Expiration Date in Inappropriate 21

A.18 Exceptions to Certification for Paperwork Reduction Act Submission 21

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B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL

METHODS 21

B.1 Respondent Universe and Sampling Methods 21

B.2 Procedures for the Collection of Information 22

B.3 Methods to Maximize Response Rates and Deal with Nonresponse 23

B.4 Tests of Procedures or Methods to be Undertaken 24

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or

Analyzing Data 25

APPENDICES

1. Legal Authorities

2. Preliminary Data Collection Instruments

3. Electronic Contact Record Form

4. Federal Register 60-Day Notice

5. CIS Policy on User Anonymity

6. Preliminary Data Analysis Plan

7. CIS Contact Centers

8. Partnership Program Fact Sheet

9. Research Program Brochure

10. Facts and Figures 2004 (CIS Annual Report)

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A. Justification

A.1 Circumstances Making the Collection of Information Necessary

The National Cancer Institute (NCI) collects demographic and customer service information from clients of the Cancer Information Service (CIS) in order to focus cancer education efforts and for program management and evaluation. The purpose of this request is to supplement CIS’ current data collection activity (OMB No. 0925-0208). Specifically, CIS would like to ask additional demographic questions in order to better assess program reach to underserved populations and impacts on these populations. In addition, CIS would like to ask clients contacting CIS for smoking cessation assistance questions about smoking/tobacco use in order to provide smoking cessation services tailored to the individual client’s needs and track their smoking behavior.

Legislative Authority. NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training and has a direct congressional mandate to disseminate information related to cancer to the public. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state‑of‑the‑art cancer treatments into clinical practice. The Health Omnibus Programs Extension of 1988 (Public Law 100-607, Nov. 4, 1988, 102 Stat. 3048) and its amendments require the NCI to establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients, their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment. The Legislative Authority (US Code 42, Sections 285a-1 and 285a-2) is included in Appendix 1.

Office of Communications. Within NCI, the Office of Communications (OC) serves as the NCI's primary voice for communicating information about cancer to the Nation. The OC’s mission is to effectively communicate the most up-to-date, evidence-based information related to cancer prevention, detection, diagnosis, treatment and survivorship. Within OC, the Office of Cancer Information Service (OCIS) is the NCI’s primary public access point. The OCIS administers the CIS, which provides cancer information to the public through a toll-free telephone service and other channels.

Cancer Information Service. The CIS serves the United States, Puerto Rico, the U.S. Virgin Islands, and the Pacific Islands through a network of 15 regional offices located at cancer centers and medical centers. The CIS provides cancer information to cancer patients, family members and friends of patients, health professionals, and the general public. In addition, the CIS provides cessation assistance to smokers and other tobacco users trying to quit. Since its inception in 1976, the CIS network has handled more than ten million calls from the public. NCI’s Executive Committee approved continuation of the CIS program in May 2003 for a 5-year contract that began in January 2005. The current contract expires January 2010. Components of the CIS include the (1) Contact Centers, (2) Partnership Program, and (3) Research Program.

The CIS Contact Centers. Four of the CIS regional offices function as Contact Centers, providing cancer information services to the public through the following access points:

• CIS toll-free number (1-800-4-CANCER). Callers from anywhere in the United States, Puerto Rico, and the U.S. Virgin Islands can use this toll-free number (callers from Guam and the Pacific Territories reach CIS through a different number). Information Specialists answer calls Monday through Friday from 9:00 am to 4:30 p.m. local time, in English or Spanish. Callers can speak with an Information Specialist, order NCI publications, or listen to recorded cancer information. Telecommunication technology ensures rapid response to callers through call routing to the next available Cancer Information Specialist in any of the Contact Centers.

• LiveHelp. LiveHelp is an instant messaging service accessed through links on the NCI and CIS websites. The service is available from 9:00 a.m. to 11:00 p.m. Eastern Standard Time, Monday through Friday. Information Specialists address online clients’ cancer-related questions and provide assistance in navigating NCI’s Web site (http://www.Cancer.gov).

• E-mail Response Service. Individuals can contact CIS via e-mail by using the “contact us” function on the NCI and CIS websites. CIS provides individualized e-mail responses within 5 to 7 business days. An automated response is generated immediately to inform clients that a personalized response will follow and advising them to contact CIS by telephone if they need assistance right away.

The Contact Centers provide smoking cessation assistance through the Smoking Quitline toll-free number (1-877-44U-QUIT). NCI’s Smoking Quitline can also be accessed through the National Network of Tobacco Cessation Quitlines, which offers a toll-free number (1-800-QUITNOW). Information about the National Network is presented in Section A.2. CIS recently began offering a callback service to telephone clients in order to provide ongoing motivation and counseling (see details in Section A.2). In addition, smokers can seek assistance through LiveHelp, which can be accessed from NCI’s smoking cessation website (http://www.smokefree.gov) as well as the NCI and CIS websites.

The CIS Partnership Program. In addition to providing information and assistance on a one-on-one basis, the CIS also extends its reach to the public through the Partnership Program. The program focuses on minority and medically underserved populations who do not have adequate access to health information and services. Currently CIS has active partnerships with more than 900 nonprofit, private, and other government agencies at the national, regional, and state levels. (For additional information about the Partnership Program see Appendix 8.)

The CIS Research Program. The CIS Research Program involves collaborative research with investigators from academic institutions, cancer centers, and other institutions to carry out research in the field of health communication. The focus is on applied research that explores and tests effective communication approaches to educating the public about cancer and contributes to the nation’s cancer control efforts. Priority is given to studies where findings can be directly translated and applied to service delivery. The Research Program is guided by a research agenda, which articulates research questions and priority areas of study. (For additional information about the Research Program see Appendix 9.)

Need to Supplement Current Data Collection. CIS currently collects demographic and customer service information from a sample of individuals who contact CIS by telephone and LiveHelp (OMB No. 0925-0208). The data are used for program planning and evaluation purposes. Current approval is for eight questions for telephone clients: age, education, ethnicity, race, sex, contacted the CIS previously, how found out about CIS, and ZIP code. A ninth question is approved for LiveHelp to determine client category (e.g., patient, family member/friend of patient). This request is to supplement the current data collection by adding: (1) four demographic questions (plus possible follow-up questions) related to income, health insurance coverage, and regular source of health care; (2) 20 smoking intake questions (plus possible follow-up questions) for individuals who call CIS for smoking cessation assistance; and (3) one follow-up smoking question for smoking cessation clients participating in the callback service. (See preliminary data collection instruments in Appendix 2.)

A.2 Purpose and Use of the Information

The purpose of the proposed data collection is three-fold: (1) to collect demographic information that will allow CIS to better assess the extent to which it is reaching underserved populations and measure the success of promotions and programs targeting these populations; (2) to collect comprehensive needs assessment data for smoking cessation clients in order to provide more effective individualized counseling; and (3) to track smoking behavior among smoking cessation clients over the callback period.

Demographic Questions. In support of the NCI’s mission to address the unequal burden of cancer across populations groups in the U.S., CIS seeks to meet the cancer information needs of minority and medically underserved populations. CIS reaches out to underserved populations through the Partnership Program and special promotional efforts to increase awareness and use of CIS. CIS is also committed to research investigating barriers to cancer information and education among underserved populations. A recently approved Request for Applications will fund research focusing on barriers to use of the CIS among underserved populations and strategies to increase utilization and impact (see http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-015.html). The proposed demographic questions will provide critical baseline data for these studies, which are expected to be funded in September 2006.

As NCI places increasing emphasis on addressing health disparities, it is imperative that NCI Institutes and Centers are able to demonstrate program impacts on underserved populations. In a 2004 report, Making Cancer Health Disparities History, a trans-HHS Progress Review Group recommended the collection of “high quality data that will allow HHS to accurately describe cancer health disparities and monitor progress in removing them.” Under its currently approved data collection, CIS is limited in its ability to measure clients’ socioeconomic status and determine if they are from underserved populations as there are no measures of income or health care access. Collection of information about clients’ income, health insurance coverage, and whether they have a regular source of health care, together with the demographic information currently collected, will allow CIS to better measure its success in reaching underserved populations and also to evaluate promotions and programs targeting these populations. To address these needs, OMB clearance is sought to ask a sample of CIS clients additional demographic questions related to income, health insurance coverage, and usual source of health care (see preliminary data collection instrument in Appendix 2).

Smoking Questions. The proposed smoking questions are comprised of (a) 20 smoking intake questions which will be asked as part of the client needs assessment, and (b) one smoking follow-up question which will be asked of clients participating in the callback service (described below). The smoking intake questions will allow Information Specialists to conduct more comprehensive needs assessments of smoking cessation clients. An in-depth understanding of the client’s smoking/tobacco use history, previous quit attempts, and motivation to quit is essential to providing effective individualized counseling. Currently, Information Specialists gather smoking-related information informally over the course of the interaction. This request is to standardize the data collection by adding 20 smoking intake questions for smoking cessation clients. The proposed smoking follow-up question will allow CIS to track smoking behaviors among smoking cessation clients participating in the callback service and assess the impact of the quitline service on quit rates.

Two recent changes to CIS’ smoking cessation services necessitate this additional data collection. First, in 2004 the Secretary of the Department of Health and Human Services initiated a plan to establish the National Network of Tobacco Cessation Quitlines to ensure access to quitline services for all Americans. NCI is collaborating with the Centers for Disease Control and Prevention (CDC) and the North American Quitline Consortium, comprised of state and other quitlines, to implement this National Network. NCI is the portal for the quitline number (1-800-QUITNOW) and, as such, routes calls to state quitlines and handles calls from states that do not offer their own quitline services. As part of the Consortium’s Research and Evaluation Work Group, NCI has helped to develop a core set of smoking intake questions that will be asked of callers to all quitlines. By using these core questions, data from the NCI quitline can be compared to data from other quitlines. Results from these analyses will improve understanding of quitline operations, promotion, and effectiveness and can be applied directly to improving the NCI quitline services. The proposed smoking intake questions include the core questions being used across the National Network also questions specific to CIS’ intake and needs assessment process (see preliminary data collection instrument in Appendix 2).

In another recent change, beginning in 2005 NCI expanded its quitline services to provide proactive

counseling callbacks following the client’s initial call to CIS. With this new approach, Information

Specialists call back smoking cessation clients who have agreed to the service up to four times in order to provide ongoing support and counseling. The decision to incorporate proactive callbacks was made based on research evidence that smoking quit rates increase with this approach. Callbacks are scheduled at strategic intervals when smoking cessation clients are most likely to need support and motivation - the day/evening before the quit date and 3, 7, and 14 days following the quit date.

A.3 Use of Information Technology and Burden Reduction

The respondent’s burden from this survey will result from: (1) for telephone clients, the time spent hearing the questions and responding to them; or (2) for LiveHelp clients, the time spent reading the questions online and selecting answers. The speed of response to the telephone questions is enhanced by the technology used to record the answers in the Electronic Contact Record Form (ECRF), an automated data collection tool used for the current data collection (see ECRF in Appendix 3). The speed of response to the web-based questions will be enhanced by the latest electronic forms technology used on the web.

A.4 Efforts to Identify Duplication and Use of Similar Information

The proposed data collection is designed to collect information about individuals who contact the CIS for cancer information or smoking cessation assistance via telephone or LiveHelp. This information is not available from any other source. The CIS keeps abreast of surveys and other research focusing on individuals seeking cancer information or smoking cessation assistance, and of data collection efforts undertaken by other health/cancer information services (e.g., other federal agencies, HMOs, international cancer information services). However, none of these data collections meet CIS’ needs for information specific to CIS clients.

A.5 Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this study.

A.6 Consequences of Collecting the Information Less Frequently

The demographic information will be collected only once for clients contacting CIS by telephone or LiveHelp. The smoking intake questions will also be asked only once of smoking cessation clients, at the time of the initial telephone contact. The smoking follow-up question will be asked of quitline clients participating in the callback service up to four times.

A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The data collection will be implemented in a manner consistent with 5 CFR 1320.5.

A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

As required by 5 CFR 1320.8(d), comments on this information collection were solicited from the general public in a notice that appeared in the Federal Register Volume 71, No. 13, page 3313 on January 20, 2006 (a copy of the notice appears in Appendix 4). No public comments were received in response to that notice.

In developing the proposed data collection, CIS consulted with other NCI Institutes and Centers, specifically: Nancy Breen, Economist, Division of Cancer Control and Population Sciences; Bradford Hesse, Director of Health Communication and Informatics Research Branch, Division of Cancer Control and Population Sciences; and Erik Augustson, Behavioral Scientist, Tobacco Control and Research Branch. CIS has also consulted with its counterparts in other countries (e.g., CancerBACUP in the U.K.) and inventoried other federal agencies and private organizations that offer 1-800 numbers for health information and assistance. For the smoking intake questions, CIS worked closely with the CDC and the North American Quitline Consortium to develop priority questions for quitline callers. Where appropriate, questions were drawn from existing sources. For the demographic questions, sources include NCI’s Health Information National Trends Survey (HINTS) (OMB No. 0925-0507), the California Health Interview Survey (UCLA Center for Health Policy Research, California Department of Health Services, Public Health Institute) (OMB No. 0925-0544), and the American Community Survey (U.S. Bureau of the Census) (OMB No. 0607-0810). For the smoking intake questions, sources include the Current Population Survey, 2003 Tobacco Use Supplement (U.S. Bureau of the Census and U.S. Bureau of Labor) (OMB No. 0925-0368).

To obtain the perspective of cancer patients on its services and data collection activities, CIS will seek input from consumer representatives through NCI’s Consumer Advocates in Research and Related Activities (CARRA) program. This program draws on the experience of individuals affected by cancer to represent the views of cancer survivors and family members in NCI's daily activities.

A.9 Explanation of Any Payment or Gift to Respondents

Respondents will not receive any payment or gift for answering the questions.

A.10 Assurance of Confidentiality Provided to Respondents

Information Specialists do not collect or record clients’ names or contact information except when information is to be sent or clients have agreed to smoking cessation callbacks. Within 24 hours after the interaction and any follow-up actions are completed, all identifying information is deleted. For smoking cessation clients who agree to callbacks, personal identifier information is retained until callbacks are completed or the case is closed.

Information Specialists follow procedures to assure clients that their responses will be kept confidential and will not be disclosed, except as required by law, to anyone but CIS staff members involved in quality assurance, research, and evaluation and research partners. Appendix 5 presents CIS Policy and Procedure No. 4004, User Anonymity. Information Specialists are trained to ask questions in a discrete and non-threatening manner, explain the reasons for collecting information, and not to survey clients who are emotionally upset or hostile. Before asking the demographic questions at the end of the session, Information Specialists obtain consent by asking: “May I ask you a few questions to help us evaluate our program and see who we are serving? Your responses will be completely confidential.” CIS plans an additional step to obtain consent from telephone clients prior to the session. Currently, before callers are connected to an Information Specialist they hear a recording informing them that calls may be monitored or recorded for quality assurance purposes. CIS plans to add an informed consent statement to this recording: “So that we can better serve you, the Information Specialist will ask you for some background information about yourself or the person for whom you are calling. Your responses will be completely confidential.”

Responses to the LiveHelp web survey are voluntary and clients are anonymous. Client identity is stripped from the session before it appears on the Information Specialist’s screen and CIS has full 128 bit encryption Secure Socket Layer (SSL) that secures chats between LiveHelp clients and Information Specialists.

A.11 Justification for Sensitive Questions

Of the proposed demographic questions, the income question is the only one of a potentially sensitive nature. Obtaining a measure of clients’ income is essential so that CIS can assess the program’s reach to underserved populations and evaluate the effectiveness of promotions and programs targeting these populations. The proposed income question, together with measures of health insurance coverage (proposed), regular source of health care (proposed), race/ethnicity (collected under current approval), and educational attainment (collected under current approval), will allow CIS to better identify underserved populations.

A number of the smoking intake questions are also potentially sensitive, such as questions about pregnancy, smoking/tobacco use behaviors, person(s) likely to influence the client’s effort to quit, and others in the household who smoke/use tobacco. This information is necessary for Information Specialists to conduct a thorough needs assessment and provide effective individualized counseling. In CIS’ experience, clients share much of this information over the course of the interaction without the Information Specialist having to ask directly. Thus, no major difficulties are anticipated in collecting this information.

A.12 Estimates of Hour Burden Including Annualized Hourly Costs

Rationale for proposed approach. Consistent with the current demographic data collection, the four new demographic questions will be asked of a sample of telephone and LiveHelp clients in the following categories: (1) cancer patients, no treatment; (2) cancer patients, in treatment; (3) cancer patients, post treatment; (4) cancer patients, recurrence; (5) cancer patients, status unknown; (6) family members/friends of cancer patients; and (7) general public. Other types of clients (e.g., health professionals, media representatives) will not be surveyed. Twenty-five percent of eligible telephone clients and 50 percent of eligible LiveHelp clients will be sampled for the demographic questions. In addition, 50 percent of eligible telephone clients responding to special CIS promotions will be sampled for the demographic questions. Overall, it is expected that approximately 36 percent of clients will be sampled for the demographic questions. These sampling levels provide sufficient data to support program planning and evaluation and to measure the success of special promotions and programs.

The smoking intake questions will be asked of all telephone clients who contact CIS for smoking cessation assistance. Asking all smoking cessation clients these questions is necessary as the information collected is the basis for providing individualized counseling. The smoking follow-up question (“When was the last time you smoked a cigarette, even a puff?”) will be asked at each callback for clients participating in the callback service. Responses to this question will guide the follow-up counseling and also allow CIS to assess smoking quit rates at each callback point.

Burden and Cost Estimates. Annualized estimates for numbers of respondents and respondent burden are presented in Table A.12-1.

• Telephone Clients. Burden hour estimates for the four demographic questions are based on the results of pretests conducted with CIS clients in January and February 2006. Respondents took an average of 108.5 seconds to complete these questions. The estimate used in the calculation of total burden is .0334 hours, and the total annual number of respondents is estimated as 40,700.

• Quitline Clients. Burden hour estimates for the smoking questions are based on the results of pretests conducted with five individuals in November 2005. Respondents took an average of 111 seconds to answer the 20 smoking intake questions and 6 seconds to answer the follow-up question. The estimates used in the calculation of total burden are .0334 hours for the smoking intake questions and .0167 for the smoking follow-up question. Of the smoking cessation clients, about 80% are expected to receive one-time reactive service and about 20% to participate in the proactive callback service. For both the reactive service clients and the callback service clients, about 36 percent will be sampled for the demographic questions and thus will answer both the demographic and smoking intake questions. The total annual number of quitline respondents is estimated as 6,700. Table A. 12-1 presents respondent and burden estimates for subgroups of smoking cessation clients.

• LiveHelp Clients. Burden hour estimates for the four demographic questions are based on CIS’ experience that the time required for clients to answer questions online is approximately the same as the time required to answer questions on the telephone. Thus, the estimated mean time to complete the demographic questions is 108.5 seconds (same as for telephone). The estimate used in the calculation of total burden is .0334 hours, and the total annual number of LiveHelp respondents is estimated as 2,000.

Table A. 12-1. Respondent and Burden Estimate

Type of Respondents	Estimated Number of Respondents	Estimated Number of Responses per Respondent	Average Burden Hours per Response	Estimated Total Annual Burden Hours Requested
Telephone Clients1
Demographic questions	40,700	1	.0334	1359
Quitline Smoking Cessation Clients1,2
Reactive Service Clients
Demographic & smoking intake questions	1,900	1	.0668	127
Smoking intake questions only	3,400	1	.0334	114
Proactive Callback Service Clients3
Demographic & smoking intake questions plus follow-up question	500	1	.0668	33
		4 (follow-up question only)	.0167	33
Smoking intake questions plus follow-up question	900	1	.0334	30
		4 (follow-up question only)	.0167	60
Subtotal Quitline Clients	6,700
LiveHelp Clients4
Demographic questions	2,000	1	.0334	67
Total ..........	49,400			1823

¹ Approximately 36% of telephone and quitline clients will be sampled for the demographic questions.

² 100% of smoking cessation clients will be asked the smoking intake questions.

³ 100% of smoking cessation clients participating in the proactive callback service will be asked the smoking follow-up question (at up to 4 callbacks).

⁴ Approximately 50% of LiveHelp clients will be sampled for the demographic questions.

An estimate of annualized cost to respondents for the hour burden for this information collection is presented in table A.12-2. There are no direct costs to the respondents themselves. The cost to respondents may, however, be calculated in terms of the costs of their time spent in responding to the questions. Assuming an hourly wage of $18.09 per hour (based on the mean U.S. hourly wage, July 2004, Bureau of Labor Statistics) and the annualized estimated total burden of 1,823 hours, the annualized cost to respondents is $32,978.

Table A. 12-2. Annualized Cost to Respondents

Type of Respondents	Number of Hours	Hourly Wage	Respondent Costs
Telephone Clients
Demographic questions	1359	$18.09	$24,584
Quitline Smoking Cessation Clients
Reactive Service Clients
Demographic & smoking intake questions	127	$18.09	$2,297
Smoking intake questions only	114	$18.09	$2,062
Proactive Callback Service Clients
Demographic & smoking intake questions plus follow-up question	66	$18.09	$1,194
Smoking intake questions plus follow-up question	90	$18.09	$1,628
Subtotal Quitline Clients
LiveHelp Clients
Demographic questions	67	$18.09	$ 1,212
Total* ..........	1,823		$32,978
* Total does not equal sum of costs per respondent group due to rounding.

A. 13 Estimate of Other Total Annual Cost Burden to Respondents or Record keepers

There are no Capitol Costs, Operating Costs, and or Maintenance Costs to report.

A.14 Annualized Cost to the Federal Government

The estimated average annual cost to the Federal government for collection of data during the 3-year period is $66,048. Labor costs for Year 1 are computed as follows: $28 per hour for Information Specialists for 2,097 hours, $30.00 per hour for Supervisors for 105 hours, and $47.00 per hour for Contact Center Managers for 21 hours. Estimates for all years include indirect costs at 36% and labor escalated at 5 percent per year. Labor covers the time to ask the questions and record the answers during phone calls, quality assurance of records, preparation of database files, and supervision and training.

Table A.14-1 Annual Cost to the Federal Government
Labor	Year 1	Year 2	Year 3	Total	Annualized
Total	$62,853	$65,996	$69,296	$198,145	$66,048

A.15 Explanation for Program Changes or Adjustments

This is a revision of a currently approved collection (OMB No. 09025-0208) allowing CIS to ask (1) five demographic questions of a sample of 25 percent of eligible telephone clients (50 percent in the case of special promotions), (2) three customer service questions of 100 percent of eligible telephone clients, and (2) nine questions (five demographic, three customer service, and user type) of a sample of 50 percent of eligible LiveHelp clients, resulting in a total estimate of 1,951 annual burden hours. This revised clearance request seeks approval to add (1) four demographic questions to be asked of a sample of telephone and LiveHelp clients; (2) 20 smoking intake questions to be asked of all telephone smoking cessation clients; and (3) one smoking follow-up question to be asked of all smoking cessation clients participating in the callback service. The estimated annual burden hour will be increased by an estimated 1,823 hours annually.

A.16 Plans for Tabulation and Publication and Project Time Schedule

The CIS publishes an annual report, Facts and Figures, presenting CIS client data (see Appendix 10). Data are presented for subgroups of clients (e.g. by ethnicity), but no statistical analyses are conducted for this report. CIS staff and research partners conduct additional in-depth analyses of client data for a variety of presentations and publications. CIS will implement procedures to ensure confidentiality and appropriate use of client data, including stripping all identifying information from data shared with research partners. In addition, research partners will be required to sign a confidentiality agreement. All publications and manuscripts resulting from research collaborations are reviewed and approved by the CIS Project Office before they are finalized and disseminated. CIS staff who are investigators on a study analyzing data from the Electronic Contact Record Form which is expected to result in a publication will seek approval from NCI’s Institutional Review Board prior to conducting analyses.

If this data collection request is approved, it is anticipated that many of the collaborative research studies will focus on barriers to use of the CIS among underserved populations and strategies to increase utilization and impact among these populations. Recent examples of research utilizing CIS client data are included in a special issue of the Journal of Health Communication (Volume 10, Supplement 1, 2005).

Data Analysis Plan. A preliminary data analysis plan outlines analyses that will be performed on a routine monthly and annual basis (see Appendix 6). In addition, as part of the Research Program CIS and other NCI researchers and CIS research partners will conduct further in-depth analyses on an occasional basis that address research questions articulated in the CIS Research Agenda. CIS will begin collecting data immediately upon receipt of OMB approval. Data will be compiled on a monthly basis thereafter.

A.17 Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB expiration date will be displayed.

A.18 Exceptions to Certification for Paperwork Reduction Act Submission

No exceptions to the certification statement are required by this information collection.

B. Collection of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Methods

The potential universe of CIS clients is 218 million respondents, the approximate population (> age 18) of the United States. In 2004, CIS provided services to 136,547 telephone clients (1-800-4-CANCER), 8,302 quitline clients, and 8,769 LiveHelp clients. Based on the CIS budget, restrictions on the number of phone lines and increased use of the Internet, significant increases in call rates to 1-800-4-CANCER are not expected. The numbers of LiveHelp and quitline clients are expected to increase somewhat as a result of the public’s increasing reliance on the Internet for health information and promotion of the National Network quitline number.

Data from the current OMB approved collection indicate that 90 percent of the individuals who contact CIS via telephone or LiveHelp fall within the categories sampled for demographics. Consistent with the current data collection, 25 percent of eligible telephone clients will be routinely sampled for demographics and 50 percent of those responding to special promotions will be sampled. Based on experience during the current data collection period, it is estimated that about 36 percent of eligible telephone clients will be sampled overall. Fifty percent of eligible LiveHelp clients will be sampled (the higher sampling rate is due to the lower response rate among LiveHelp clients). All clients who call the quitline for smoking cessation assistance will be sampled for the smoking intake questions. Based on CIS experience with the callback service to date, it is estimated that about 20 percent of quitline clients will participate in the callback service. All of these clients will be asked the smoking follow-up question at up to 4 callbacks. Overall, it is estimated that 49,400 CIS clients will respond to the demographic and/or smoking questions (see Table A.12-1).

B.2 Procedures for the Collection of Information

Data will be collected by Information Specialists using the Electronic Contact Record Form (ECRF), which will be modified to incorporate the new questions (see current ECRF in Appendix 3.) The ECRF will be programmed to trigger the demographic questions for 25 percent of eligible telephone clients (50 percent in the case of special promotions) and 50 percent of eligible LiveHelp clients. The ECRF will trigger the smoking intake questions for all clients seeking smoking cessation assistance and the smoking follow-up question for all clients participating in the callback service.

Information Specialists will collect the smoking intake information at the beginning of the telephone interaction as part of the needs assessment process. Much of this information will be collected passively as clients naturally share information about their smoking/tobacco use and history. Information Specialists will actively ask questions as necessary, using a conversational style whereby questions will be woven into the conversation rather than asked in a highly structured format. The smoking follow-up question (“When was the last time you smoked a cigarette, even a puff?”) will be asked during the initial portion of counseling callbacks, also in a conversational style when possible, in order to determine smoking status and counseling needs.

The demographic questions may also be asked at naturally occurring and appropriate points in the conversation, or at the conclusion of the conversation together with the currently approved demographic and customer service questions. Consistent with the procedure used for the current data collection for LiveHelp clients, a unique URL will be generated and pushed to the client at the close of the session and the client then answers the questions online. The URL will remain active until midnight on the day of the session.

B.3 Methods to Maximize Response Rates and Deal with Nonresponse

The response rate for the demographic questions under the current clearance has averaged approximately 83 percent over recent years (telephone and LiveHelp combined). The proposed demographic questions are expected to yield similar response rates. The only question of potential concern in terms of refusals is the income question. However, CIS’s experience with a series of studies conducted in collaboration with researchers at Yale University, from which the income question was drawn, indicates that only about six percent of respondents refuse to provide income information. The expected response rate for the smoking intake questions is 85 percent, based on the experience of the California State Quitline which uses similar questions.

CIS monitors calls and reviews transcripts of LiveHelp sessions to ensure that Information Specialists are providing services and collecting data in an appropriate manner and according to CIS policies and procedures. Any issues of concern related to the proposed data collection will be addressed through supervision and training.

B.4 Test of Procedures or Methods to Be Undertaken

The demographic questions were pretested with nine callers to CIS’ Northwest Region Contact Center in January 2006. Questions were revised based on the pretest results and the new set of questions pretested with nine callers in February 2006. The smoking questions were pretested with five individuals in November 2005 for the purposes of determining burden hour estimates.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting

and/or Analyzing Data

As indicated in Section A.16, CIS does not plan to conduct statistical analyses of client data on a routine basis. For occasional research that involves statistical analyses, CIS will consult with other NCI researchers and CIS partners as appropriate.

Data management and analysis will be performed by the NCI Project Office and Aspen Systems Corporation, a firm with expertise in data management and analysis with which the OCIS has worked since 1995. Contact information for Aspen Systems: Ellen Berman, Program Director, Aspen Systems Corporation, 2277 Research Blvd., Rockville, MD 20850, 301-519-5000/ [email protected].