Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns
Generic Information Collection
OMB No. 0920-0800
Request for Reinstatement
Supporting Statement Part A
April 30, 2018
Cheryll C. Thomas
Division of Cancer Prevention and Control
Phone: 770-488-3254
Fax: 770-488-4760
E-mail: [email protected]
4770 Buford Highway NE | Bldg. 107
Chamblee, GA 30341
MailStop F76
Supported by:
Centers for Disease Control and Prevention
National Center for Chronic Disease Prevention and Health Promotion
Division of Cancer Prevention and Control
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 A12-A: Estimated Annualized Response Burden for each Method…………………
Table A12-B: Estimated Annualized Cost to Respondents………………………………...
Table A16-A: Prototype Focus Group Schedule for Cancer Communication
Campaigns……………………………………………………………....
List of Appendices
A1. Legislative Authority: Public Health Service Act, 42 U.S.C. 241
A2. Legislative Authority: Public Health Service Act, 42 U.S.C. 247b-17
B1. 60-Day Federal Register Notice
C. Example Questions for the Focus Group Screening Form
D. Example Consent Form
E. Example Questions for the Focus Group Discussion Guide
Goal of the study: To plan, develop, and/or tailor cancer-related health messages and communication campaigns.
Intended use of the resulting data: To design, produce, and disseminate colorectal cancer and gynecologic cancer educational materials and information for the general public and for health care providers.
Methods to be used to collect data: Focus groups.
The subpopulation to be studied: General public and health care providers.
How data will be analyzed: Focus group methodology.
Abstract
CDC is requesting a three-year Reinstatement of a currently expired generic clearance. Formative research will be conducted. Information will be collected through focus groups involving the general public, health care professionals, or specific target audiences. Example screening questions, example discussion group questions, and an example consent form are included in this submission to provide an overview of the types of proposed information collection. No changes to the scope of the clearance or data collection methodology are proposed. There are no changes in the annualized estimates for the number of respondents and burden hours.
OMB approval will be requested separately for each information collection activity conducted under the generic clearance. CDC will submit a written request to OMB describing each activity’s specific purpose, methods, and burden estimate.
A. JUSTIFICATION
A1. Circumstances Making the Collection of Information Necessary
The Centers for Disease Control and Prevention (CDC), Division of Cancer Prevention and Control (DCPC), requests Office of Management and Budget (OMB) renewal of a generic clearance to conduct audience research to effectively plan new and/or tailor existing cancer communication campaigns. The information collection for which approval is sought is in accordance with CDC’s mission to conduct, support, and promote efforts to prevent cancer, reduce its risk, increase early detection and better treatment, and improve the quality of life for cancer survivors authorized by Section 301 of the Public Health Service Act (PHSA, 42 U.S.C. 241). A copy of the legislation is included in Appendix A1—Legislative Authority.
Cancer is the second leading cause of death in the United States, exceeded only by heart disease. In 2014 (the most recent year numbers are available), nearly 1.6 million were diagnosed with cancer, more than 591,000 died of the disease, and more than 14 million cancer survivors were living in the United States (http://www.cdc.gov/uscs).
Among cancers affecting both men and women, colorectal cancer is the nation’s second leading cause of cancer deaths. In 2014—
Nearly 140,000 people in the United States were diagnosed with colorectal cancer, including more than 73,000 men and more than 66,000 women.
51,651 people in the United States died from colorectal cancer, including more than 27,000 men and more than 24,000 women.
There is strong scientific evidence that colorectal cancer screening helps prevent the disease, by finding precancerous polyps that can be removed before they turn into cancer. Screening also helps find this cancer early, when treatment works best. However, a recent CDC study found that in 2012, only 65.1% of U.S. adults were up-to-date with CRC screening, and 27.7% had never been screened. The proportion of respondents who had never been screened was greater among those without insurance (55.0%) and without a regular care provider (61.0%) than among those with health insurance (24.0%) and a regular care provider (23.5%).
The prevention and control of gynecologic cancers is another area of emphasis for DCPC. Nearly 96,000 women in the United States were diagnosed with a cancer affecting the reproductive organs in 2014. In the same reportable year, more than 30,000 women in the United States died of some form of gynecologic cancer—with ovarian cancer representing the majority of deaths (USCS, 2014).
DCPC plans to continue awareness activities as specifically authorized by the Gynecologic Cancer Education and Awareness Act of 2005, Section 247b-17 of the PHSA, also known as Johanna’s Law. This legislation was unanimously passed by the U.S. House and Senate (109th Congress) in December 2006, signed into law by the President in January 2007, and reauthorized in December 2010 under H.R. 2941. A copy of the authorizing legislation is provided in Appendix A2. The reauthorization underscores the continued Congressional priority to increase gynecologic cancer awareness and knowledge among women and health care providers.
CDC received first-time congressionally mandated funding in fiscal year 2006 to develop, implement, and evaluate a national gynecologic cancer awareness campaign, Inside Knowledge: Get the Facts About Gynecologic Cancer. The fiscal year 2008 Senate Appropriations Language Full Committee Report states, “The Committee is encouraged by the progress that has been made by CDC, in coordination with the Office of Women’s Health to initiate a national education campaign on Gynecologic Cancers. The Committee strongly urges the rapid completion of the evaluation of past and present activities to increase the awareness and knowledge regarding gynecologic cancers and the creation of a strategy for improving efforts to increase awareness and knowledge of the public and health care providers with respect to gynecological cancers.”
Since first receiving OMB’s approval of the generic clearance (0920-0800) for Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communications Campaigns in 2008, CDC has conducted multiple rounds of focus groups for both the Inside Knowledge: Get the Facts About Gynecologic Cancer Campaign and the Screen for Life: National Colorectal Cancer Action Campaign, as well as other CDC cancer communication campaign initiatives. During the more recent renewal period (December 31, 2014 through December 31, 2017) of the generic clearance to conduct focus group research, CDC has conducted focus groups to assess beliefs, attitudes, and knowledge about colorectal and gynecologic cancers, and to test creative concepts and approaches among providers and the general public.
This research, and the focus group research that preceded it since receipt in 2008 of initial OMB clearance to conduct focus groups for cancer prevention and control communications campaigns, has enabled CDC to more effectively design, produce, and disseminate colorectal cancer and gynecologic cancer educational materials and information for the public and for health care providers. New materials are included on both campaign web sites, http://www.cdc.gov/screenforlife and http://www.cdc.gov/cancer/knowledge.
In addition, research conducted as part of this generic clearance has resulted in multiple peer-reviewed manuscripts published in scientific journals and presentations at scientific conferences.
In this renewal request, we are requesting in the same number of burden hours and respondents. Since both campaigns have now been in existence for several years, and we have conducted the initial and extremely valuable formative research, we now have an adequate base on which to conduct more targeted research that will serve to supplement and enhance previous formative research and previously tested creative approaches. This will allow us to most effectively reach and appeal to the target audiences of both campaigns. Additionally, previous work conducted as part of this OMB clearance allows us to more precisely estimate the necessary burden.
The Health Communication Process
In an effort to fulfill its mission, DCPC supports the scientific development, implementation, and evaluation of various health communication campaigns, with a focus on specific cancer burdens. DCPC efforts are rooted in the Health Communication Process, a scientific model developed by the U.S. Department of Health and Human Services’ National Cancer Institute to guide sound campaign development. The Health Communication Process framework consists of four stages: 1) planning and strategy development, 2) developing and pretesting concepts, messages, and materials, 3) implementing the program, and 4) assessing effectiveness and making refinements (National Cancer Institute, 2002). The phases of program development are circular in nature such that there is an ongoing loop of planning, implementation, and refining to retain scientific accuracy, reflect current audience knowledge and needs, and, ultimately, maximize overall effectiveness of the effort.
One critical facet of the health communication process model is its ability to illustrate the evaluation spectrum beginning with formative evaluation (stage 2), process evaluation (stage 3), and extending to outcome or summative evaluation (stage 4) (Cooper et. al, 2005). Formative evaluation often is conducted during program development to glean valuable information on the problem as well as the knowledge, attitudes, beliefs, and practices/behaviors of the target audience(s). Process evaluation assesses previously implemented program tactics, often through quantifiable means. Outcome evaluation measures overall population change that may or may not have occurred as a result of an organized effort. Strategic participation in all stages of the evaluation spectrum will increase the likelihood of achieving the goals and/or objectives of a health communication campaign.
Initial data collection efforts will continue to focus on formative evaluation activities, including colorectal and gynecologic cancer message, concept, and/or materials testing, similar to the work previously conducted under this generic clearance (OMB No. 0920-0800). As cancer burdens evolve and priorities shift, it is possible that DCPC will be engaged in additional communication campaign efforts beyond its existing commitments related to colorectal and gynecologic cancers. Therefore, as the health communication process model dictates, the need to collect information from the public will also evolve and shift. Accordingly, it is highly probable that these efforts will be mandated by Congress with aggressive deadlines, as is the case with the Inside Knowledge: Get the Facts About Gynecologic Cancer campaign. Thus, campaign planners must be able to conduct formative audience research quickly. This request for a generic clearance will enable DCPC to meet this need.
Privacy Impact Assessment
Overview of the Data Collection System
The general public and health care providers will be asked to participate in focus groups. Two focus group modes will be used: in-person and telephone. In-person focus groups allow for observation of body language and other subtle cues requiring participants’ assembly in one location. Conversely, telephone focus groups only support auditory contact, but can reach participants in diverse geographic locations, accommodate people with busy schedules and those unable to travel, and are cost-effective (Hurworth, 2004). Given the complementary nature of in-person and telephone focus groups, it is not surprising that a systematic review (Cooper et. al, 2003) found that telephone focus groups are typically conducted in tandem with in-person focus groups.
Transcripts of the focus groups will be made and will be maintained for up to 24 months from the focus group date.
Items of Information to be Collected
In-person and telephone focus groups to be conducted under the authority of this generic OMB clearance will assess numerous qualitative dimensions that include, but are not limited to, cancer knowledge, attitudes, beliefs, behavioral intentions, information needs and sources, clinical practices (among health care providers), and compliance with recommended cancer screening. Insights gained from the focus groups will assist in the development and/or refinement of campaign messages and materials, as well as assist in determining best strategies for dissemination of campaign materials and messages. Appendix E provides example questions that could be used to construct a focus group discussion guide or an interview guide.
CDC will not be privy to the last names, mailing addresses, telephone numbers or email addresses of any of the focus group participants. These individuals will be recruited using proprietary databases of professional organizations (e.g. American Medical Association Masterfile®, commercial focus group companies, and other sources). Eligibility criteria will be established for all focus group participants, and potential participants will be screened during a telephone interview or a self-administered screener (see Appendix C for example questions that may be used to construct a screening instrument). No personal identifying information used in the recruitment process will be linked to the data collected in the focus group discussions. Thus, no personal information in identifiable form will be collected by CDC. Every focus group participant will be advised that all information he or she provides during the focus group will be treated in a secure manner, unless otherwise compelled by law (an example consent form is provided in Appendix D).
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 and, thus, 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 generic clearance request is to continue to conduct formative evaluation activities, including message, concept, and/or materials testing for cancer prevention and control health communication campaigns. OMB’s approval of DCPC’s generic clearance 0920-0800 has resulted in the successful execution of several formative and concept and message testing focus groups in support of the Screen for Life and Inside Knowledge campaigns. Outcomes of such audience research include development of campaign products in accordance with the knowledge learned, as well as publication of study findings. Such manuscripts include one published in the Journal of Women’s Health regarding women’s awareness and knowledge of gynecologic cancer (Cooper et al., 2011), and another published in Health Promotion Practice focusing on reaching audiences about colorectal cancer screening through donated media placements of public service announcements (Cooper et al., 2013). Additional manuscripts are in development.
While Screen for Life and Inside Knowledge are two very distinct initiatives with unique messaging, both campaigns require focus group testing with consumers and health care professionals so that resources can be used to direct campaign efforts in the most efficient and audience-appropriate manner. The Screen for Life and Inside Knowledge campaigns are described in more detail below.
Screen for Life: National Colorectal Cancer Action Campaign
Screen for Life: National Colorectal Cancer Action Campaign is a multimedia awareness campaign created by CDC in 1999 (in limited partnership with the Health Care Financing Administration – now the Centers for Medicare and Medicaid Services – and the National Cancer Institute. These partners’ participation ended a short time later). In an effort to educate Americans about colorectal cancer and the benefits of screening, the campaign targets men and women aged 50 and older as well as health care providers. Specific populations, such as African Americans and Hispanics, are also embedded in the target audience segment.
Basic campaign messages are the following:
Among cancers affecting both men and women, colorectal cancer is the second leading cancer killer in the United States.
Don’t wait for symptoms to be screened. Colorectal polyps and early-stage cancer do not always cause symptoms, especially at first. That’s why it is important to be screened for colorectal cancer.
Screening saves lives.
Screening helps prevent colorectal cancer. Screening tests help find precancerous polyps so they can be removed before they turn into cancer.
Screening helps find colorectal cancer early, when treatment can be very effective.
Risk increases with age, and most colorectal cancers occur in people aged 50 and older.
Medicare and most insurance plans help pay for colorectal cancer screening.
If you are 50 or older, see your doctor and get screened regularly for colorectal cancer.
Campaign materials, most in both English and Spanish, include television, radio, and digital public service announcements (PSAs), print advertisements, posters, fact sheets and brochures for patients, a fact sheet for health care providers, out-of-home advertising, newspaper articles, and video and audio news releases in English and Spanish. In 2004, the campaign began a partnership with the Entertainment Industry Foundation’s (EIF) National Colorectal Cancer Research Alliance (NCCRA) and its cofounder Katie Couric, to produce print and broadcast PSAs and other materials, including print materials featuring Ms. Couric and Terrence Howard, and broadcast PSAs featuring actors Morgan Freeman, Diane Keaton, Jimmy Smits, Mr. Howard, and Meryl Streep.
Screen for Life’s Web site (www.cdc.gov/screenforlife) includes campaign background information, information about colorectal cancer, scientific resources, and campaign materials that can be downloaded and/or ordered for use in communities, medical practices, and other settings. The Web site also serves as a resource for health educators, health care providers, state and local organizations, and others interested in colorectal cancer. All 50 state health departments, two tribal organizations, and the District of Columbia are active partners in the campaign, along with CDC’s Colorectal Cancer Control Program grantees. For these partners, CDC supports their educational and awareness activities by designing and adapting materials that are easy to localize, download and print; and by offering free local tagging for broadcast PSAs.
Screen for Life PSAs are distributed nationally to a broad range of television, radio, and print media outlets. The television PSAs are distributed to approximately 1,000 TV stations in all 210 U.S. media markets, as well as to national networks and national and regional cable systems. Donated placements for TV PSAs total 700,000 to-date. Radio PSAs are distributed to approximately 1,200 radio stations that appeal to adults age 50 and older, African Americans, and/or Hispanics, garnering over 1.1 million placements so far. Print PSAs are sent to approximately 2,000 magazines and 5,500 daily and weekly newspapers, with more than 5600 placements to-date. Print and broadcast materials are also sent to state health departments and are available on the campaign Web site. Appropriate tracking mechanisms are in place to measure and monitor audience impressions and other significant data related to TV, radio, print, and other media. Since the campaign’s launch, SFL PSAs have garnered more than 19 billion udience impressions (the number of times the PSAs have been seen or heard), worth $248 million in donated media placements.
Campaign priorities include developing new print and broadcast PSAs, as well as materials specifically for use by health care providers. These activities require focus group research to ensure the campaign products are developed based on demonstrated need, are medically and scientifically accurate, and are appealing to the target audiences. The proposed generic clearance is a critical element of DCPC’s overall plan to meet this need.
Inside Knowledge: Get the Facts About Gynecologic Cancer
CDC’s Inside Knowledge campaign educates women and health care providers about the signs and symptoms, risk factors, screening tests (if available), and prevention strategies associated with the five main types of gynecologic cancer: cervical, ovarian, uterine, vaginal and vulvar. The primary audiences for this initiative consist of women of all ages, races, and ethnicities as well as health care providers. The central messages of Inside Knowledge are—
There are several types of gynecologic cancers. Each has unique signs and symptoms.
Pay attention to your body and know what is normal for you. Gynecologic cancers have warning signs.
When gynecologic cancers are found early, treatment is most effective.
If you notice any unexplained signs or symptoms that last for two weeks or longer, see a doctor right away.
Get a Pap test regularly to screen for cervical cancer. (Cervical cancer is the only cancer for which screening is recommended.)
Get the HPV vaccine, if you are 11–26 years old.
If you are diagnosed with a gynecologic cancer, see a gynecologic oncologist—a doctor who has been trained to treat cancers of a woman's reproductive system.
As mandated by Congress, CDC develops materials to educate women and health care professionals about the five main gynecologic cancers and disseminates messages and materials across a wide variety of media and through partner organizations, such as the General Federation of Women’s Clubs and the National Comprehensive Cancer Control Program grantees. Campaign materials consist of a robust library of patient education resources, including print and broadcast public service announcements (PSAs), posters, fact sheets, and brochures, many of which are available in English and Spanish. These materials can be found at www.cdc.gov/cancer/knowledge and www.cdc.gov/spanish/cancer/knowledge/ . Tracking data show that since launching its first PSAs in September 2010, the campaign PSAs have generated nearly 4.9 million audience impressions worth $187 million in donated placements. Additionally, Inside Knowledge has sponsored a paid media initiative, generating 1.8 billion impressions and driven millions of people to the campaign’s Web site to learn more. To-date, there have been more than 10 million visits to the campaign’s Web site.
As funding allows, CDC will support activities to help to inform future implementation of the Inside Knowledge campaign. Such activities require focus group research to ensure the campaign products continue to be developed with audience accuracy, appeal, and overall need. The proposed generic clearance is a critical element of DCPC’s overall plan to meet this need.
The Screen for Life and Inside Knowledge campaigns are key DCPC activities. The tools and experience to be gained through audience research in these areas have added value, since they also can be applied to other cancer prevention and control campaigns over the three years of the proposed generic clearance. The ability to tailor information collections to specific circumstances and the ability to move rapidly from one phase of the Health Communication Process to another are major advantages of the generic clearance format. In some cases, preliminary cancer control messages may already exist, and DCPC could begin focus group testing at a point corresponding to a later stage of the Health Communication Process. The proposed generic clearance will provide DCPC with the flexibility to conduct tailored information collections on an as-needed basis.
Privacy Impact Assessment Information
Using a reference set of example items (Appendix E) tailored information collection instruments will be designed to meet campaign-specific, population-specific, and/or context-specific needs. Data collection for each focus group will be modeled on such example questions, similar questions, or ad hoc questions specific to the project. The information collected will be used by DCPC to appropriately plan for and develop new consumer and health care provider educational and awareness materials, tailor existing campaign efforts, and to do so in an iterative manner consistent with the Health Communication Process.
CDC will not collect information in identifiable form.
A3. Use of Improved Information Technology and Burden Reduction
Electronic data collection methods have limited applicability to focus groups, other than video- or audio-taping discussions. However, whenever possible, DCPC staff will employ electronic technology to collect and process data in order to reduce respondent burden and aid in data processing and reporting efficiency.
Efforts have been made to design items that are easily understandable, not duplicative in nature, and least burdensome. In all instances, the number of items 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-wide review, CDC has determined that the planned data collection efforts do not duplicate any other current or previous data collection efforts.
A5. Impact on Small Businesses or Other Small Entities
As is the case with Screen for Life and Inside Knowledge, many communication campaigns incorporate health care professionals into the target population. When formative, materials-testing, and/or outcome research is a necessity with this audience, CDC works through established medical and professional societies and research contractors to gain access and obtain necessary participation. Research efforts will be carefully planned to minimize the burden on physician practices and 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, often encompassing concept, message, and materials testing activities, is essential in pre-testing materials to evaluate a wide variety of dimensions that include, but are not limited to, appeal, saliency, clarity, cultural appropriateness and readability/understandability. If a concept and/or a message is not tested, 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 an irrelevantly perceived message 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.
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
As required by 5 CFR 1320.8(d), a notice for public comments was published in the Federal Register on December 13, 2017(Vol. 82, No. 238, pages 58606-58607; see Appendix B1). No public comments have been received.
A8.b Efforts to Consult Outside the Agency
The proposed protocol and reference set of example questions were developed and reviewed extensively by DCPC staff and others directly involved in implementing the DCPC communications campaigns.
A9. Explanation of Any Payment or Gift to Respondents
Incorporating modest incentives to aid in recruitment is considered justifiable in order to boost response rates and defray the cost of participation (e.g., transportation and childcare). Also, it is standard practice among commercial market researchers to offer incentives to participants in message and materials-testing focus groups.
As shown by the literature referenced below, the payment of incentives can provide significant advantages to the government in terms of direct cost savings and improved data quality.
While impact of monetary compensation of focus group participation has not been empirically studied, Krueger (1994) cautions that without providing minimal levels of monetary compensation, insufficient numbers of participants will attend and results will not be useful. However, there is substantial evidence that monetary incentives increase response rates to focus groups (Krueger, RA and Casey, MA(2009)).
Level of Incentive Payment
Focus group participants may be provided with a modest incentive for their participation. If CDC determines that an incentive is needed to support successful completion of a project, the information collection request submitted to OMB will include a case-specific justification describing the circumstances, amount, and type of incentive proposed. CDC understands that approval of any incentive offered under each individual genIC is at the discretion of OMB.
Reduced Data Collection Cost
While there is minimal published literature on focus group incentive rates, empirical evidence suggests that motivation is increased when an incentive is present. Discussion of remuneration as a technique to speed responses and expand response rates is not complete without mentioning the trade-off between the costs of incentives and the costs of efforts to foster timely and complete participation. The goal is to find the highest response rate at the lowest overall cost to the government.
In the National Adult Literacy Survey by Berlin (1992) and colleagues (OMB No. 1850-0654, exp. 8/31/1993), a $20 incentive resulted in not only higher response rates from the sample cohort but also lower costs per completed case than the comparison group. Importantly, the incentives provided higher response rates from adults with lower-than-average levels of education and basic literacy and numeracy skills (e.g., the NELS: 88 subset of high school dropouts).
Reduced Bias
The most important aspect of an incentive plan may be its potential for reducing response bias, underreporting bias, and similar sources of error. Findings from the National Survey of Family Growth (a study in which childbearing and family planning patterns are collected from young women) demonstrated that incentives not only had positive effects on response rates, but they also increased the accuracy of reporting. Incentives are necessary for testing in order to ensure that those who are willing to participate are as representative as possible of the wider public. Failure to provide a basic incentive is likely to bias samples in the direction of well-educated individuals who are generally predisposed to be helpful (http://www.cdc.gov/nchs/nsfg.htm).
A10. Assurance of Confidentiality Provided to Respondents
Privacy Act Determination
The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) has reviewed this OMB submission and determined that the Privacy Act is not applicable. Privacy Act applicability will be re-reviewed for each individual information collection request submitted under this generic clearance.
Safeguards
Respondents will be recruited by the data collection contractor using established record systems such as proprietary databases of professional organizations (e.g., the American Medical Association), commercial focus group companies, and other sources. CDC will not create a record system for this project. Although respondent names and contact/demographic information may be used to determine eligibility and to schedule focus group participation, personal identifying information will not be linkable at any time to response data collected during focus group discussions. A minimum amount of demographic information may be retained in focus group notes for purposes of analysis, but will not be sufficient to identify respondents. Participants will be informed that focus groups will be video and/or audio-taped and transcribed, and that tapes will be destroyed after completion of each report on findings. DCPC staff, in conjunction with a communications contractor, will collect and evaluate the audience research data.
Consent
All information provided by respondents will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. Typically, informed consent will be obtained from respondents (see example in Appendix D) and they will be informed that participation is voluntary; they do not have to answer questions if they do not want to, their responses will be treated in a secure manner, and they can stop participating at any time. Typically, the information collection activities conducted under this generic will not require IRB review and approval since this the primary purpose is to inform and improve existing public health awareness campaigns . If a specific information collection is determined to require IRB approval, DCPC will obtain the required approval.
Nature of Response
Respondent participation is entirely voluntary, as noted in the example consent form (Appendix D).
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 preventive 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
A. DCPC estimates that 800 respondents will be involved in focus groups each year (80 focus groups @ 10 respondents per group). The discussion guide for each focus group will generally consist of questions drawn from a set of example questions (see Appendix E) that will be customized according to the type of cancer being addressed, target population, and phase of the health communications development process. The average burden for a focus group discussion will be two hours.
Similarly, potential respondents will be screened for interest and eligibility using a customizable screening form, also based on a set of example questions (see Appendix C). Based on our experience recruiting focus group participants from master lists of eligible or interested persons, it is estimated that twice the target number of needed respondents must be screened in order to yield the targeted number of respondents. The estimated burden per response for screening is three minutes.
The estimated burden to respondents is summarized in Table A12-A below.
Table A12-A: Estimated Annualized Burden to Respondents
|
Form Name |
Number of Respondents |
No. of Responses per Respondent |
Average Burden per Response (in hours) |
Total Burden (in hours) |
General Public |
Screening Form |
960 |
1 |
3/60 |
48 |
|
Focus Group Guide |
480 |
1 |
2 |
960 |
Health Care Professionals |
Screening Form |
640 |
1 |
3/60 |
32 |
|
Focus Group Guide |
320 |
1 |
2 |
640 |
Total |
Total |
1,680 |
|||
Information will be collected over a three year time period. There are no costs to respondents except their time to participate in the focus groups. The total annualized burden to respondents is 1,680 hours.
B. Approximately 60% of respondents will be members of the general public and 40% of respondents will be health care professionals. Table A12-B presents the calculations for cost of respondents’ time using two categories of mean hourly wages from U.S. Department of Labor, Bureau of Labor Statistics May 2016 National Occupational Employment and Wage Estimates. The total estimated annualized respondent cost (including the screening form) is $91,950.
Table A12-B: Estimated Annualized Cost to Respondents
|
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Total Burden (in hours) |
Average Hourly Wage Rate |
Total Cost |
General Public |
Screening Form |
960 |
1 |
48 |
$23.86 |
$1,145 |
|
Focus Group Guide |
480 |
1 |
960 |
$23.86 |
$22,906 |
Health Care Professionals |
Screening Form |
640 |
1 |
32 |
$101.04 |
$3,233 |
|
Focus Group Guide |
320 |
1 |
640 |
$101.04 |
$64,666 |
Total |
|
|
|
|
|
$91,950 |
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 $491,600 ($245,800 per campaign). This figure encompasses the salary of two GS-13 employees, communication contract costs, as well as fees for identifying and recruiting participants, incentive payments, facility rental, and transcription.
Estimated Annualized Cost to the Government, per Campaign and Total |
|
Cost Category |
Estimated Annualized Cost |
Federal employee costs, per campaign (20% FTE of 2 GS-13 @ $102,000/yr) |
$40,800 |
Contractual costs for focus group facility rental, focus group moderator, participant recruitment, and report on findings, per campaign |
$205,000 |
Subtotal, per Campaign |
$245,800 |
Total, average of 2 Campaigns per year |
$491,600 |
A15. Explanation for Program Changes or Adjustments
There are no changes for this reinstatement.
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. A three year generic clearance is requested.
Table A16-A: Prototype focus group schedule for cancer communication campaigns
Activity |
Time Schedule |
Focus group recruitment |
4-5 weeks after OMB approval |
Focus group testing |
6-12 weeks after OMB approval |
Analysis of focus group results (topline reports) |
12-20 weeks after OMB approval |
Report Writing/Recommendations to CDC based on Findings |
3-6 months after OMB approval |
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 OMB expiration date will be displayed.
A18. Exemptions to Certification for Paperwork Reduction Act Submissions
No certification exemption is being sought.
References
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| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | sxw2 |
| Last Modified By | SYSTEM |
| File Modified | 2018-08-14 |
| File Created | 2018-08-14 |