Supporting Statement A

Screen for Life: National Colorectal Cancer Action Campaign

2015 Focus Group Testing with the General Public

Submitted Under OMB No. 0920-0800

Focus Group Testing to Effectively Plan and Tailor

Cancer Prevention and Control Communication Campaigns

Generic Information Collection

Expiration date December 31, 2017

Supporting Statement Part A

June 22, 2015

Contracting Officer Representative:

Cynthia A. Gelb

Division of Cancer Prevention and Control

Phone: 770-488-4708

Fax: 770-488-3040

E-mail: [email protected]

Supported by:

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion

Division of Cancer Prevention and Control

4770 Buford Highway, NE, Mailstop F-76

Atlanta, GA 30341

TABLE OF CONTENTS

A. Justification

A1. Circumstances Making the Collection of Information Necessary

A2. Purpose and Use of the Information Collection

A3. Use of Improved Information Technology and Burden Reduction

A4. Efforts to Identify Duplication and Use of Similar Information

A5. Impact on Small Businesses or Other Small Entities

A6. Consequences of Collecting the Information Less Frequently

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A9. Explanation of Any Payment or Gift to Respondents

A10. Assurance of Confidentiality Provided to Respondents

A11. Justification for Sensitive Questions

A12. Estimates of Annualized Burden Hours and Costs

A13. Estimates of Other Total Annual Cost Burden to Respondents or
Recordkeepers

A14. Annualized Cost to the Government

A15. Explanation for Program Changes or Adjustments

A16. Plans for Tabulation and Publication and Project Time Schedule

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate

A18. Exemptions to Certification for Paperwork Reduction Act Submissions

References……………………………………………………………………………………

List of Tables

Table A1-A: Focus Group Locations

Table A12-A: Estimated Annualized Burden for Respondents……………………..

Table A12-B: Estimated Annualized Cost to Respondents…………………………...

Table A14-A: Estimated Annualized Cost to the Government……………………….

Table A16-A: Estimated Focus Group Schedule for Cancer Communication Campaigns

List of Attachments

Attachment A-1. Focus Group Discussion Guide (English)

Attachment A-2. Focus Group Discussion Guide (Spanish)

Attachment B-1. Screening and Recruitment Form (English)

Attachment B-2. Screening and Recruitment Form (Spanish)

Attachment C-1. Consent Form (English).

Attachment C-2. Consent Form (Spanish)

Attachment D. Creative Concepts Brief

1. JUSTIFICATION

• Goal of the study: To examine knowledge, attitudes, and behaviors related to colorectal cancer screening; and to assess Screen for Life campaign messages and creative concepts for use in public service advertisements that encourage colorectal cancer screening.

• Intended use of the resulting data: Findings will help CDC’s Screen for Life campaign managers fine-tune messaging; avoid unintended consequences of untested messages and materials; and ensure that the most effective advertisements are produced and disseminated.

• Methods to be used to collect information: Focus groups will be conducted in English and/or Spanish in five U.S. cities.

• The subpopulation to be studied: The target population for the Screen for Life campaign is men and women aged 50 – 75 years. Focus group participants will be men and women aged 48-72 years.

• How data will be analyzed:  Inductive, thematic coding will be used to analyze participant comments.

A1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC), Division of Cancer Prevention and Control (DCPC), submits this new information collection request as part of a previously approved generic clearance (OMB control number 0920-0800) to conduct audience research supporting the Screen for Life: National Colorectal Cancer Action Campaign. The information collection for which approval is sought is in accordance with CDC’s mission, as described by Section 301 of the Public Health Service Act (PHSA, 42 U.S.C. 242; see Appendix A1).

A1. Circumstances Making the Collection of Information Necessary

In 2011, the most recent year for which statistics are available, more than 135,000 people in the United States were diagnosed with colorectal cancer and more than 51,000 people died from the disease (US Cancer Statistics Working Group). While colorectal cancer is largely preventable through routine screening beginning at age 50, millions of Americans are not getting screened as recommended. Screening rates have increased, but in 2012, only 65% of U.S. adults were up-to-date with colorectal cancer screening; 7% had been screened, but were not up-to-date; and 28% had never been screened (CDC).

Activities to promote screening for colorectal cancer are a high priority for CDC’s Division of Cancer Prevention and Control (DCPC). In 1999, DCPC launched the Screen for Life: National Colorectal Cancer Action Campaign. The campaign targets the general U.S. population of men and women aged 50 and older, as well as specific populations such as African Americans and Hispanics. The campaign also includes messages directed toward health care providers who provide screening services or referrals for screening services. All 50 state health departments, two tribal organizations, and the District of Columbia partner with CDC in Screen for Life campaign efforts.

To support campaign goals and partner organizations, CDC designed Screen for Life materials that are easy to adapt for use at the community level. These materials are available to campaign partners through the Screen for Life Web site (www.cdc.gov/screenforlife) which houses scientific, technical, and educational resources that can be downloaded and/or ordered for use in communities, medical practices, and other settings. Currently available campaign materials include television and radio public service announcements (PSAs) in English and Spanish, print and digital advertisements, posters, fact sheets and brochures in English and Spanish, out-of-home displays (e.g., in transit stations, shopping malls, elevators), news articles, and video and audio news releases. CDC provides free local tagging for PSAs delivered through television ads. The Web site also serves as a resource for health educators, health care providers, state and local organizations, and others interested in colorectal cancer. Screen for Life materials were developed after CDC conducted multiple rounds of focus groups to assess beliefs, attitudes, and knowledge about colorectal cancer, and to test creative concepts and approaches among the general public and health care providers. The focus groups enabled CDC to more effectively design, produce, and disseminate colorectal cancer educational materials and information for the public and for health care providers.

Basic campaign messages are—

• Colorectal cancer is the second leading cancer killer in the United States.

• Screening helps prevent colorectal cancer, by finding precancerous polyps so they can be removed before they turn into cancer.

• Screening helps find colorectal cancer early, when treatment can be very effective.

• There are screening test options – talk to your doctor about which test is right for you.

• Don’t wait for symptoms. Polyps and early-stage colorectal cancer do not always cause symptoms. That’s why screening is important.

• If you’re 50 or older, see your doctor and get screened regularly for colorectal cancer.

• Screening saves lives.

Current campaign priorities include developing new English and Spanish print and broadcast PSAs. This process requires additional focus group testing of creative concepts and approaches to assess their appeal and whether they are sufficiently motivating to people in the Screen for Life campaign’s target audiences.

CDC plans to conduct 28 in-person focus groups in summer-fall 2015. Four focus groups will be conducted in English in each of four cities: Chicago, Los Angeles, Miami and New York (16 total). Three focus groups will be conducted in Spanish in each of four cities: Chicago, Houston, Los Angeles, and Miami (12 total). A maximum of nine men and women ages 48-72 will participate in each group, resulting in an estimated total of 252 focus group participants (9 respondents/group x 28 groups = 252 respondents).

Table A1-A. Focus Group Locations

Focus Group Location	Number of Focus Groups in English	Number of Focus Groups in Spanish
Chicago, Illinois	4	3
Houston, Texas	0	3
Los Angeles, California	4	3
Miami, Florida	4	3
New York, New York	4	0
Total	16	12

Focus group discussions will be facilitated by a professional focus group moderator using a Focus Group Discussion Guide (see Attachments A-1 [English] and A-2 [Spanish]). Participants will be asked questions that specifically relate to the key central messages of the Screen for Life campaign (listed above) to assess their general knowledge and attitudes toward colorectal cancer and screening. This qualitative data collection and analysis will help to confirm the appeal and usability of existing campaign messages and materials, as well as provide information about knowledge gaps among the key audiences that can be addressed in the PSAs being developed and future material development or refinement.

The groups will be asked to consider several creative concepts and approaches for new TV and print PSAs, to determine whether they present clear, understandable information that is appealing and sufficiently motivating in encouraging screening for colorectal cancer. Details about the materials to be tested are included in Attachment D, Creative Concepts Brief. Concepts will be tested using an iterative process that involves multiple rounds of focus groups. Typically, each round is conducted in a different U.S. city. In the first city, the participants in each English group will be shown the same English creative concepts. Participants in each Spanish group will be shown the same Spanish concepts. In the second city, and in subsequent cities, the creative concepts may be slightly modified and some may be dropped, based on feedback from participants in the previous city where groups were held.

Identification of Web Site(s) and Web Site Content Directed at Children Under 13 Years of Age

No Web-based data collection methods will be used. There is no Web content directed at children under 13 years of age.

A2. Purpose and Use of the Information Collection

The purpose of this information collection is to continue to conduct formative evaluation activities inclusive of materials testing for the Screen for Life campaign. Focus group participants will be asked questions that allow CDC to assess their knowledge, attitudes, and behaviors related to colorectal cancer and to provide feedback and opinions about the PSA creative concepts and approaches they are shown. Outcomes include the development of specific, targeted, culturally appropriate campaign products in accordance with the knowledge gained, as well as refinement of current materials. The information collected will be used by DCPC to tailor existing campaign efforts, and develop forthcoming campaign materials in an iterative manner consistent with the Health Communication Process (National Cancer Institute 2002). CDC may also disseminate key findings about public perceptions and educational needs to public health and communication professionals. Manuscripts describing information obtained from the focus groups will be developed for publication in public health practice, communication, and/or other journals.

A3. Use of Improved Information Technology and Burden Reduction

Whenever possible, DCPC staff use electronic technology to aid in data processing and reporting efficiency. However, electronic information collection methods are not applicable to the semi-structured discussion format utilized in qualitative focus group testing.

Efforts have been made to design discussion questions that are easily understandable, not duplicative in nature, and minimally burdensome. In all instances, the number of questions posed will be held to the minimum required in order to elicit the necessary formative or materials-testing data.

A4. Efforts to Identify Duplication and Use of Similar Information

Based on a division and federal-wide review, CDC has determined that the planned data collection efforts do not duplicate any other current or previous information collection efforts related to the Screen for Life campaign.

A5. Impact on Small Businesses or Other Small Entities

Respondents will be individual persons. There is no impact on small businesses or other small entities.

A6. Consequences of Collecting the Information Less Frequently

As the health communication process illustrates, formative evaluation is a critical segment of a scientifically sound campaign effort. Formative evaluation, which encompasses material testing activities, is essential to assess appeal, saliency, clarity, cultural appropriateness, and readability/understandability. If materials are not assessed, then resources could be expended without necessary attention and preparation paid to the overall communication objective. Forgoing testing can also increase the likelihood of unintended consequences from a message that is not perceived as relevant, and/or decreased credibility of an organization and/or a Federal health official (Wallendorf, 2001 & Harris-Kojetin et al., 2001). Finally, if materials are not tested with the intended audience, a poor execution strategy could weaken a sound concept. For these reasons, focus groups in the selected geographic areas are necessary.

There are no legal obstacles to reducing the burden.

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances. The activities outlined in this package fully comply with all guidelines of 5 CFR 1320.5.

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A8-A Federal Register Notice

This information collection is being conducted through the generic clearance entitled “Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns,” OMB No. 0920-0800, expiration date 12/31/2017. As required by 5 CFR 1320.8(d), a notice for public comments was published in the Federal Register on June 25, 2014 (Vol. 79, No. 122, pages 36064-36065). No public comments were received. The current submission does not require publication of an additional Federal Register Notice.

A8-B. Efforts to Consult Outside the Agency

CDC manages the Screen for Life campaign. There was no consultation outside of CDC with any individuals who are not contractors or subcontractors involved in developing this project.

A9. Explanation of Any Payment or Gift to Respondents

Level of Incentive Payment

To assess the need for and amount of an appropriate token of appreciation to participants, the Screen for Life campaign consulted with four focus group planners and moderators who work on government initiatives as well as for the private sector. These individuals have extensive experience in planning and conducting focus groups, and are in constant contact with focus group facilities around the country. They are up-to-date with recruitment challenges and current practices related to incentives that aid in recruitment of focus group participants. The tokens of appreciation proposed here are based on our consultation with these experts and their extensive knowledge and experience in effective recruitment and participation. They are also consistent with past practices related to CDC’s Screen for Life campaign. In past focus groups and for the currently proposed focus groups, participants are required to travel to the focus group facility and participate in the group for 120 minutes. Providing each participant with $75 helps to show appreciation for his or her participation and recognizes the effort involved in traveling to the focus group location. Modest incentives have also been shown to aid in recruitment and to boost response rates.

A10. Assurance of Confidentiality Provided to Respondent

Overview of the Information Collection

Information collection and analysis will be conducted by contractors who specialize in health communications and marketing. The contractor will recruit respondents to participate in in-person focus group discussions that will be led by a professional moderator and attended by a note-taker. Inductive and thematic coding techniques will be used to analyze participant comments and identify themes. The contractor(s) will submit to CDC a de-identified summary report of findings. No information in identifiable form (IIF) will be transmitted to CDC.

Items of information to be collected

The target audience for this message development and testing activity is non-incarcerated, non-institutionalized men and women ages 48-72. The recruitment and screening process is designed to identify respondents who are in the target age range; speak English or Spanish; have not been previously diagnosed with colorectal cancer or other diseases of the bowel; and have not been screened for colorectal cancer or have not been screened according to recommended guidelines. Additional demographic questions are designed to ensure that focus groups include a mix of respondents.

Recruiters will ask respondents a limited number of questions for information only, such as: whether they have health insurance – which will help CDC understand if having health insurance promotes appropriate screening or, conversely, if lack of insurance is a barrier to colorectal cancer screening. Recruiters will also ask about other cancer screening tests that respondents may have had – breast cancer and prostate cancer screening tests – to help CDC understand whether respondents generally have appropriate screening tests.

During focus group discussions, participants will discuss their background knowledge, attitudes and beliefs and about colorectal cancer and colorectal cancer screening, and provide feedback on the messages and materials to be tested. This information is needed to assess the salience and appeal of materials designed to promote colorectal cancer screening.

How information will be shared and for what purpose

Information will be collected by contractors on CDC’s behalf. Discussions will also be audio- and video-taped. We do not plan to allow anyone outside of this project to listen to, watch, or read anything that is recorded. The identifiable information needed for scheduling purposes will be maintained in the contractor’s proprietary record system. CDC will not be privy to names, mailing addresses, telephone numbers or email addresses of any focus group participants. Thus, no personal information in identifiable form will be collected by CDC. CDC will receive a summary report of findings but no identifiable information about focus group participants will be included in the written notes and summaries.

Impact on the respondent’s privacy

None. No personal identifying information used in the recruitment process will be linked to the information collected in the focus group discussions.

Nature of response and opportunities to consent to sharing and submission of information

Participation in focus groups is voluntary, as explained in the Consent Form provided to participants (see Attachment C-1 [English] and Attachment C-2 [Spanish]). Participants will be informed that focus groups will be video and/or audio-taped and transcribed, that any recordings will be destroyed after completion of each report on findings, and that their names will not be included in the summary of findings provided to CDC. Participants will be informed that participation is voluntary; they do not have to answer questions if they do not want to, and they can stop participating at any time.

How the information will be secured

We will audio and video record focus group discussions and transcribe information. The information will be kept in a locked cabinet. We plan to destroy all the information following analysis.

Privacy Act determination

Respondents will be recruited by a professional market research firm that maintains its own records system. No new records system will be created. The Privacy Act does not apply.

A11. Justification for Sensitive Questions

The majority of questions asked will not be of a highly sensitive nature. However, some respondents (namely the general public) may find thinking about and discussing the disease of cancer unpleasant. A portion of respondents could consider questions about race, ethnicity, or other demographic characteristics to be sensitive, although such questions are unlikely to be highly sensitive. Additionally a portion of respondents may feel uncomfortable answering some questions about their individual cancer experiences, level of disease awareness, and/or adopted preventative behaviors (or lack thereof) associated with cancer. Such questions, if asked, would be necessary for the purposes of a targeted communication campaign and thus to the information collection. To minimize psychological distress, the moderator will inform participants that they do not have to respond to any questions they do not want to answer and they may stop participating at any time.

A12. Estimates of Annualized Burden Hours and Costs

1. DCPC estimates that 252 respondents will be involved in the proposed English- and Spanish-language focus groups. In all cases, the burden per response is two hours. The Focus Group Discussion Gide is included as Attachment A-1 (English) and Attachment A-2 (Spanish).

Potential participants will be recruited using public information through a combination of sources, including proprietary lists maintained by focus group facilities and professional focus group recruiting agents. A Screening and Recruitment Form will be delivered in-person or via telephone to potential participants identified through these partnerships (see Attachment B-1 for the English language version and Attachment B-2 for the Spanish language version).

Based on experience recruiting focus group participants in this way, it is estimated that twice the target number of needed respondents must be screened in order to yield the targeted number of respondents.

The total annualized burden to respondents is 529 hours, as summarized in Table A12-A below. The total number of responses is 756 and the adjusted average burden per response is 41.98 minutes.

Table A12-A: Estimated Annualized Burden to Respondents

Type of Respondents	Form Name	Number of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden (in hours)
General Public	Screening and Recruitment Form	504	1	3/60	25
Men and Women aged 48-72 years	Focus Group Discussion Guide	252	1	2	504
	Total	756			529

B. Table A12-B presents the calculations for cost of respondents’ time using average hourly wage information two categories of mean hourly wages.

Average hourly earnings information from the U.S. Department of Labor, Bureau of Labor Statistics Web site http://www.bls.gov/eag/eag.us.htm for April 2015 was used in the table.

The total estimated annualized respondent cost (including the screening form) is $13,156.

There are no costs to respondents except their time to participate in the focus groups.

Table A12-B: Estimated Annualized Cost to Respondents

Type of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Total Burden (in hours)	Average Hourly Wage Rate	Total Cost
General Public	Screening and Recruitment Form	504	1	25	$24.87	$622
Men and Women aged 48-72 years	Focus Group Discussion Guide	252	1	504	$24.87	$12,534
Total		756		529		$13,156

A13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers

None.

A14. Annualized Cost to the Government

The estimated average annual cost to the Federal government for the proposed focus group activities is $295,400. This figure encompasses the salaries of federal employees to oversee the data collection and contractor fees for recruiting participants to and facilitating focus groups:

Table A14-A Estimated Annualized Cost to the Government

Cost Category	Estimated Annualized Cost
Federal employee costs 10% FTE of 1 GS-13 @ $114,000/yr = $11,400	$11,400
Contractual costs for focus group facility rental, focus group moderator, participant recruitment, and information transcription	$284,000
Total	$295,400

A15. Explanation for Program Changes or Adjustments

This information collection request is submitted as part of an approved generic clearance. There are no program changes or adjustments.

A16. Plans for Tabulation and Publication and Project Time Schedule

Project Time Schedule

Table A16-1 presents the estimated timeline for conducting focus groups following receipt of OMB clearance. Information will be collected over approximately a 6 month time period and will not exceed the current approved expiration date (12/31/2017).

Table A16-A: Estimated focus group schedule for cancer communication campaigns

Activity	Time Schedule
Focus group recruitment	June – September 2015
Focus group discussions	July – October 2015
Analysis of focus group results (topline reports)	July – November 2015
Report Writing/Recommendations to CDC based on Findings	November 2015 – January 2016

Focus group findings will inform campaign planning efforts, provide guidance on efforts to refresh existing materials, and aid in the sound development of new communication products for specific cancer communication initiatives. Additionally, findings will be disseminated through presentations and/or posters at meetings and publications in peer-reviewed journals. All abstracts, poster presentations, and manuscripts will undergo CDC clearance review prior to submission to conferences or journals.

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate

The display of the OMB expiration date is not inappropriate.

A18. Exemptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

References

Centers for Disease Control and Prevention. Screen for Life: National Colorectal Cancer Campaign Web site. www.cdc.gov/screenforlife.

Harris-Kojetin, D., McCormack, L.A., Jael, L.A., Sangl, E.F., & Garfinkel, S. A. (2001). Creating more effective health plan quality reports for consumers: Lessons from a synthesis of quality assessing. Health Services Research, 36(3), 447-476.

National Cancer Institute. (2002). Making Health Communication Programs Work (NIH Publication No. 02-5145). Bethesda, MD: Department of Health and Human Services.

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2011 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2014.

U.S. Census Bureau. Quick Facts. http://quickfacts.census.gov/qfd/index.html. Accessed May 5, 2014.

Wallendorf, M. (2001). Literally literacy. The Journal of Consumer Research, 27(4), 505-511.

U.S. Bureau of Labor Statistics. http://www.bls.gov/eag/eag.us.htm Accessed May 5, 2015

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