Supporting Statement A

NC Project OMB Part A_11 03 2011.docx

Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns

Supporting Statement A

OMB: 0920-0800

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Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns

(OMB No. 0920-0800 [generic]. Expiration date January 31, 2012)


Information Collection #5

Test of Effectiveness of Screening Recruitment Messages among African American Women in North Carolina











Supporting Statement Part A





November 3, 2011


Technical Monitor:

Ingrid J. Hall, PhD, MPH

Division of Cancer Prevention and Control

Phone: 770-488-3035

Fax: 770-488-4639

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 K64

Atlanta, GA 30341


TABLE OF CONTENTS

A. JUSTIFICATION 1

A1. Circumstances Making the Collection of Information Necessary 1

A2. Purpose and Use of the Information Collection 3

A3. Use of Improved Information Technology and Burden Reduction 3

A5. Impact on Small Businesses or Other Small Entities 4

A4. Efforts to Identify Duplication and Use of Similar Information 4

A6. Consequences of Collecting the Information Less Frequently 4

A7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency 4

A9. Explanation of Any Payment or Gift to Respondents 5

A10. Assurance of Confidentiality Provided to Respondents 6

A11. Justification for Sensitive Questions 7

A12. Estimates of Annualized Burden Hours and Costs 8

A13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers 10

A14. Annualized Cost to the Government 10

A15. Explanation for Program Changes or Adjustments 10

A16. Plans for Tabulation and Publication and Project Time Schedule 10

A17. Reason(s) Display of OMB Expiration Date Is Inappropriate 12

A18. Exemptions to Certification for Paperwork Reduction Act Submissions 12

References 13



List of Attachments

Attachment A1a. Pre-discussion Information Sheet—Participant Version

Attachment A1b. Post-discussion Information Sheet—Participant Version

Attachment A2. Pre-discussion Information Sheet—Participant Version (Latina)

Attachment B. Communication Materials

Attachments C1-C3. Radio Health Messages

Attachment D1. Recruitment Flyer

Attachment D2. Recruitment Flyer (Latina)

Attachment E1. Recruitment Screener

Attachment E2. Recruitment Screener (Latina)

Attachment F. Observer Non-Disclosure Form

Attachment G. Non-Disclosure Agreement with Local Site Recruiters

Attachment H1. Informed Consent Form (AAW)

Attachment H2. Informed Consent Form (Latina)

Attachment I. IRB Approval

Attachment J1. Focus Group Moderator Guide (AAW)

Attachment J2. Focus Group Moderator Guide (Latina)

Attachment K. Pre/Post-discussion Information Sheet (Pre/Post-DIS)—Moderator Version

Attachment L. Sample Topline Summary

A. JUSTIFICATION

A1. Circumstances Making the Collection of Information Necessary

While deaths from breast and cervical cancer in women in the United States have decreased over the past several decades, mortality rates could be reduced even further by increasing cancer screening rates among women at risk (Centers for Disease Control and Prevention, 2010). To improve access to breast and cervical cancer screening among low-income, uninsured, and underinsured at-risk populations in the United States, Congress passed the Breast and Cervical Cancer Mortality Prevention Act of 1990, which authorized the Centers for Disease Control and Prevention (CDC) to create the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). Through the NBCCEDP, CDC is working to improve access to breast and cervical cancer early detection and treatment services for women who have rarely or never been screened and developing effective strategies to improve rescreening rates among women enrolled in the program. To reach these goals, the NBCCEDP seeks to increase breast and cervical cancer screening among uninsured, low-income women. Participating programs provide breast and cervical cancer screening, diagnostic testing, surveillance and follow-up, case management, public education and outreach, professional education and training, quality assurance of screening tests, coalition and partnership development, and program evaluation.

The NBCCEDP has had success in delivering mammography screening tests to participants; however, nationally, the program is estimated to reach only approximately 13% of eligible women aged 40 to 64 years with mammograms (Tangka et al., 2006). As a result, a priority of the NBCCEDP is to identify effective strategies to increase enrollment among program-eligible women who have never received breast cancer screening. A need exists to improve outreach to this population of at-risk women for whom services exist and are accessible, but who are not participating for reasons not yet identified in previous studies. Why NBCCEDP-eligible women do not participate in screening is not well understood.

CDC plans to conduct a communication campaign in North Carolina to increase utilization of NBCCEDP services by women who are eligible for those services. The effectiveness of health communication messages/materials can be evaluated in many ways; however, all involve getting pre and post message/materials development feedback directly from the target audience (Atkin & Freimuth, 1989; Palmer, 1981). The proposed new information collection will gather pre message/material development information (via focus groups) on audience characteristics, thoughts about health, breast cancer, screening and viable messages to educate women about breast cancer and screening directly from NBCCEDP-eligible Latinas. We will also gather data directly from African American women to test existing communication materials (Attachment B) and radio health messages (Attachments C1-C3) developed to increase mammography screening among NBCCEDP-eligible African American women.

CDC’s Division of Cancer Prevention and Control (DCPC) is requesting Office of Management and Budget (OMB) approval to conduct message/material testing research with African American women using materials and messages from the African American Women and Mass Media (AAMM) project previously implemented and evaluated in Georgia (OMB No. 0920-0652, Formative Research on Issues Related to the Use of Mass Media in African-American Women, exp. 3/31/2006; and OMB No. 0920-0738, Formative Research on Issues Related to the Use of Mass Media in African-American Women, Phase II, exp. 12/31/2007). The AAMM is a multiphase, community-based intervention using radio and print media to increase knowledge and awareness of the availability of local NBCCEDP screening services and increase use of program low- or no-cost mammograms among eligible African American women. In addition, we request approval to conduct formative research with women who are Hispanic/Latina (hereafter referred to as Latina) to learn their thoughts about health, breast cancer, screening and early detection, and viable messages to educate women about breast cancer and increase screening among those women who may qualify for free or low-cost breast cancer screening. This project addresses the following DCPC strategic priorities:

  • Develop and assess the effectiveness of methods to influence the public regarding the prevention and early detection of cancer

  • Develop, implement, and rigorously test interventions designed to increase screening rates among women at highest risk

  • Evaluate and disseminate interventions that increase screening behaviors

Privacy Impact Assessment

Overview of the Data Collection System

Information will be collected by CDC’s data collection contractor in 12 focus group discussions in North Carolina. Focus groups will be facilitated by a professional moderator. Focus group participants will include women who are eligible for use of NBCCEDP services and thereby represent a low-income, medically uninsured population. Although educationally disadvantaged individuals are not the target group, many who are economically disadvantaged have a low level of education. For this information collection, we are using the same eligibility criteria that the NBCCEDP uses to determine program enrollment eligibility. To be eligible for enrollment in the State Breast Cancer Control Program (BCCP) and receive federally funded breast cancer screening, a woman must be

  • within the age requirements for recommended breast cancer screening,

  • at or below 200% of the Federal poverty guidelines,

  • uninsured,

  • aged 40–64 years,

  • a resident of the State of North Carolina.

Additionally, study subjects must participate in English.


Items of Information to be Collected

The screening instruments will collect information necessary to identify members of the target audience(s) (see Attachments E1 and E2). The discussion guide for the eight moderated focus groups with African American women (Attachment J1) will explore whether or not the messages and materials previously used for a GA study are clear and understandable to the target audiences in NC, are personally relevant to the NC target audiences, have sensitive or controversial elements, capture the audience’s attention, match the NC audiences’ preferences for wording and format, and confirm that selected settings and activities for intervention implementation are appropriate. The questions in the moderator’s discussion guide for the four formative focus groups with Latinas (Attachment J2) will explore women’s thoughts about health, breast cancer, screening and early detection, and viable messages to educate women about breast cancer and mammography screening. Each focus group participant will complete a Pre-discussion Information Sheet (Pre-DIS) (see Attachments A1a and A2) at the beginning of the focus group discussion. For the groups with African American women, following the discussion of the print materials (see Attachment J1) the moderator will administer the Post-discussion Information Sheet (Post-DIS) (Attachment A1b).



A2. Purpose and Use of the Information Collection

The purpose of this information collection request is to conduct research activities including concept, message, and materials testing, for health communication campaigns in the area of cancer prevention and control in the state of North Carolina. There will be no comparisons to the focus groups held in GA.


The information collection (via focus groups) is designed to assess target audiences’ knowledge of breast cancer and screening services, use of the NBCCEDP in North Carolina (NC), sources of information to obtain health information, and information on community issues, services, and events to determine if these can be used as viable sources (and channels) to communicate with African American and Latina women in NC. Study results will inform the design, planning, and implementation of future CDC efforts and communication campaigns designed to increase the NBCCEDP participation of never or rarely screened women.


OMB-approved instruments from the GA AAMM study have been modified for the current data collection. For the Latina groups, we made minor modifications to change the language in the data collection instruments so that references are specific to Latina women (versus African American women in Georgia). For the African American groups, we modified instruments to allow for formative and materials/message testing to be done during one set of groups versus two sets of groups as was the case in the Georgia study. For both groups of women, we added two new questions to assess whether women think that health care reform will affect where they seek health care and to assess access to radio via the Internet. All instruments will be administered in English to both groups.

The results of this new collection will inform the development of health communication messages to women eligible for services through local programs in NC. The specific planned use of the information gained from this collection will help improve the NC NBCCEDP outreach to eligible African American women and Latinas and, consequently, work to address health disparities related to timely mammography utilization, breast cancer detection and treatment, and breast cancer mortality in these populations.

A3. Use of Improved Information Technology and Burden Reduction

The proposed project does not involve automated, electronic, mechanical, or other advanced technologies in the collection of information other than the use of audiotape to retain an accurate record of the focus group discussions. Focus group data will be collected in focus group rooms in Raleigh-Durham, Charlotte, and potentially in Greenville, NC. Participants’ use of information technology is not applicable because the Pre-discussion and Post-discussion Information Sheets will be administered in a pencil-and-paper format and focus group discussions will be conducted in person.

Because of the nature of this study and the populations in which it is conducted, it is not feasible to use information technology in the form of electronic respondent reporting. A systematic review of the evidence on literacy and health outcomes found that people who live in the South or Northeast, are female, are from certain racial or ethnic groups, are elderly, or have completed fewer years of education have a higher prevalence of low literacy (Berkman et al., 2004). Because many of the respondents in this study are likely to have low literacy rates and, as a result, may have difficulty using complicated information technology in reporting, efforts have been made to design instruments that are brief, easy to use, and understandable. In addition, the study investigators have carefully considered the content, appropriateness, and phrasing of questions in the screeners, Pre-DISs, and the focus group moderator guides. While focus group questions are asked by the moderator, additional research staff members will be available to assist participants with completing the Pre-DIS.

Efforts have been made to design materials that are easily understandable, not duplicative in nature, and least burdensome. Only the minimum information necessary for the purposes of this project will be collected. Standard focus group methodology recommends conducting multiple focus groups with any one type of participant (Krueger & Casey, 2000). This is done to ensure that comparisons can be made among groups of the same types of participant and that saturation (i.e., the point when the range of all ideas is heard and no new information is collected) is reached. Despite this suggestion, the project will include only one focus group with each audience segment to reduce burden by collecting the minimum information necessary for the study, as was previously approved for the AAMM study in GA (OMB no. 0920-0652 and OMB no. 0920-0738).

A4. Efforts to Identify Duplication and Use of Similar Information

A literature review on the utility of mass media outlets in communicating public health messages showed that radio (and television) can play a role in health promotion in the African American community. Studies indicated that airing health messages on radio stations serving the African American population can be an effective way to reach a broad African American audience with information about important health issues (Chen, Kohler, Schoenberger, Suzuki-Crumly, Davis, & Powell, 2009; Hall, Johnson-Turbes, & Williams, 2010; Johnson & Birk, 1993). Other studies indicate that visual aids and media outlets may be even more effective than print materials in sharing health information, given health literacy issues in this population (O’Malley, Kerner, & Johnson, 1999; Davis, Berkel, Arnold, Nandy, Jackson, & Murphy, 1998).

However, these studies are uncommon, and there is a dearth of recent literature on how effective using radio stations that target African Americans can be in broadcasting health information to this population and, more importantly, in motivating them to seek breast cancer screening. This study proposes to test and refine the GA AAMM’s culturally-tailored radio and print messages for African American women in NC. Additionally, due to the lack of culturally-tailored materials to promote breast cancer screening among Latinas, this study proposes to conduct formative research to explore Latinas’ needs for health information, and trusted sources to develop culturally appropriate breast cancer and screening awareness materials for Latinas. There are no existing sources of information that would allow us to adapt the existing AAMM materials for use with the target NBCCEDP-eligible target audiences in North Carolina.

A5. Impact on Small Businesses or Other Small Entities

No small businesses or other small entities will be affected by collection of these data.

A6. Consequences of Collecting the Information Less Frequently

This is a one-time information collection. If CDC does not test the existing AAMM materials for use in North Carolina, the effectiveness of communications based on these materials and the AAMM communication channels may be limited. Similarly, lack of formative research with Latinas in North Carolina will limit the effectiveness of health communication messages for this target audience. There are no legal obstacles to reducing the burden further.

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

CDC published a Notice about the generic clearance request in the Federal Register on January 29, 2008 (vol. 73, no. 19, p. 5197). The proposed information collection will be conducted prior to the expiration date of the current OMB approval (OMB no. 0920-0800, exp. 1/31/2012). CDC is seeking an Extension of the generic clearance. An additional Notice was published August 17, 2011 (vol. 76, no. 159, p. 51035).

A8.b. Consultation

The following individuals inside the agency have been consulted on the design of the proposed information collection:

Kimberly Leeks, PhD, MPH

Division of Cancer Prevention and Control

Centers for Disease Control and Prevention

4770 Buford Highway NE, Mailstop K57

Atlanta, GA 30341

Phone: (770) 488-5455[email protected]


The following individuals outside the agency have been consulted on the design of the generic clearance package:

Lakeisha Johnson, MA

NC BCCCP Assistant Branch Head

Cancer Prevention and Control Branch

NC Division of Public Health

1922 Mail Service Center

Raleigh, NC 27699-1922

Phone: (919) 707-5300

[email protected]


Linda Rascoe, MEd, BSPH

NC BCCCP/WISEWOMAN Project Director

Cancer Prevention and Control Branch

NC Division of Public Health
1922 Mail Service Center
Raleigh, NC 27699-1922
Phone: (919) 707-5300
[email protected]


A9. Explanation of Any Payment or Gift to Respondents

Incentives serve as an acknowledgment that the information and time provided by respondents are valuable (Salant & Dillman, 1994). Multiple studies using a variety of data collection methodologies have shown that offering incentives increases response rates (Davis et al., 1998; Salant & Dillman, 1994; Church, 1993; Groves & Couper, 1998; Singer, Gelber, Van Hoewyk, & Brown, 1997; Singer, Van Hoewyk, & Maher, 2000). Incentives are offered to increase the likelihood of participation and to thank respondents for their time and input to the study. Although the incentive amount may vary (e.g., by the type of interviewees, the length and burden of the interview), the effect of an incentive on the response rate does not vary by data collection type (Salant & Dillman, 1994).

Participants who complete all or any part of the focus group will be given a $50 cash payment, which serves as an incentive, recognizes their time and willingness to participate in the group and may be used to defray expenses such as transportation and child care. The cash incentive will be noted during the recruitment phase to encourage participation. After the focus group is complete, the respondent will receive the incentive in cash and sign a form documenting receipt of reimbursement. An early-bird raffle of $25 will also be conducted for each group to encourage participants to arrive 15 minutes before the scheduled time of their focus group.

The choice of a $50 monetary incentive is consistent with what was offered to African American participants in the Georgia study. In Georgia, the monetary incentive, in addition to an extra $15 to cover transportation and child care costs, helped facilitate recruitment and our ability to fully populate the focus groups and motivate women to participate through the entire group. Not using an incentive may reduce the number of women who agree to participate and actually attend the discussion for which they have been scheduled. Under-populated focus groups adversely affect the amount and quality of data collected and, thus reduce the utility of the focus group discussions. Group dynamic, quality of discussion, and themes raised could be affected if fewer people participate in the groups. Having the expected number of recruited participants attend each scheduled session is crucial, since budget constraints generally preclude the possibility of offering additional focus group sessions if turnout to a scheduled session is low. Morgan (1997) argues that failure to achieve adequate recruitment is the most important challenge facing focus group recruiters and suggests that using incentives helps with recruitment and participation.


Alternatives to a monetary incentive include refreshments, meals, gifts, vouchers, and participation in a raffle. While these are viable incentives, studies suggest, and our experience indicates, that use of a monetary incentive is extremely effective in ensuring adequate numbers of people in this study population participate in the focus groups. Therefore we do not offer alternative incentives as the only incentive to group participation.



A10. Assurance of Confidentiality Provided to Respondents

Response data will not be identified, stored, or retrieved by respondent name, therefore, the Privacy Act does not apply. Efforts will be made to ensure that respondents’ personal information is secure at every step of the protocol, including recruitment and conduct of focus group discussions. Below is a description of how we will safeguard respondent privacy.

  • Although full names and contact information of focus group respondents will be temporarily recorded for tracking purposes throughout recruitment, identifiable information will be destroyed after recruitment is completed and participation is confirmed. The identifiers used for recruitment and scheduling purposes will not be linked to response data at any time.

  • Full names and contact information for follow-up correspondence during the recruitment protocol will be kept in locked file cabinets or password-protected network files. All recruitment activities will be recorded and updated in a recruitment tracking database in Microsoft Excel. Audiotapes of the focus groups will not be transcribed and all will be destroyed at the end of the study.

  • All study results will be presented in aggregate form. In every instance, respondents will be told that the information they provide in the focus groups and on the Pre-DIS and Post-DIS will be treated in a secure manner and will not be disclosed except as required by law.

  • Focus group participants will not be identified by full name in the notes or in any of the analyses or written reports. Participants' first names will be displayed on name tents during the focus group discussion.

  • CDC’s data collection contractor will subcontract with one local site recruiter (LSR) in each data collection site to conduct focus group recruitment. LSRs will recruit screened and unscreened women using in-person intercept recruitment techniques at a variety of locations including, but not limited to, the health department, community centers, faith-based organizations, and malls. In this effort, LSRs will use audience-specific recruitment flyers (Attachment D1, Attachment D2) and a recruitment screeners (Attachment E1, Attachment E2) provided by CDC’s data collection contractor. To safeguard participants’ privacy, all identifying information about participants will be kept in locked cabinets and password-protected computer files, which will be destroyed at the end of the study. All recruitment activities will be recorded and updated in a recruitment-tracking database in Microsoft Excel.

Access to and Protection of Respondent Names

At the time of the groups, only CDC’s data collection contractor staff and the LSRs will have access to respondent names. After the focus groups have been conducted, the LSRs will provide all screeners with original copies of the recruitment logs and any lists of respondent names or other identifying information to CDC’s data collection contractor. Contractor staff will then be the only persons with access to respondent names and will store all materials with identifying information in locked file cabinets or password-protected computer files. At the conclusion of the project, all identifying information and audiotapes of the groups will be destroyed.

To further protect identifying information, all focus group observers (contractor staff and CDC researchers) will be asked to sign an observer non-disclosure agreement (Attachment F), stating that they will treat all information they hear in a secure manner, unless otherwise required by law. The LSRs subcontracted by CDC’s data collection contractor will also be required to complete a non-disclosure agreement (Attachment G).

Focus group participants will be asked to complete an informed consent form (Attachment H1, Attachment H2). At the start of each focus group, the focus group moderator will read the consent form out loud. The consent form details the limited risks and benefits of their participation, the purpose of the group, the expected duration of the group, their rights as respondents, and contact information of study personnel. The form also informs the respondents that participation is voluntary. Respondents will be asked about any concerns or questions they might have before they are asked to provide their signature, indicating consent. The moderator will serve as a witness and will also sign the consent form of each respondent.

CDC’s data collection contractor will maintain continual communication with the LSRs throughout the recruitment process. LSRs will be trained and instructed to ask all questions in the recruitment screener before terminating due to ineligibility. LSRs will be instructed to complete a daily log documenting their recruitment efforts and will fax the logs to CDC’s data collection contractor staff daily. The logs will capture the date, type of activity (such as attending a church social), and time spent in each attempted recruitment location. First and last names as well as contact information will only be recorded for women who are screened and eligible to participate in a focus group. LSRs will be instructed not to record names and contact information for women who are screened but found to be ineligible for focus group participation.

Per their required non-disclosure agreement, LSRs will keep all screeners and original copies of the logs used to track recruitment in a secure place until meeting with CDC’s data collection contractor on the first day of the focus groups. At that time, all screeners and original copies of the logs will be given to CDC’s data collection contractor. In addition, CDC’s data collection contractor will record and update all recruitment activities on a Microsoft Excel spreadsheet. To safeguard respondents’ privacy, CDC’s data collection contractor will keep all identifying information about participants in locked cabinets and password-protected computer files, which will be destroyed at the end of the study.

On April 8, 2011, the focus group portion of this project obtained approval from CDC’s data collection contractor’s institutional review board (IRB). IRB approval was amended to include the four formative research focus groups with Latinas on August 30, 2011. A copy of the IRB approval letter is included in Attachment I.

A11. Justification for Sensitive Questions

The majority of questions asked will not be of a highly sensitive nature, but some questions may be viewed as somewhat sensitive by a portion of respondents. During screening for focus group eligibility, respondents will be asked to provide limited personal (i.e., demographic) information to identify members of the target audience(s). These topics include race/ethnicity, income, educational level, and previous diagnosis of cancer. These questions are necessary because the research investigates a health disparity related to African American and Latina women’s use of breast cancer screening services and seeks input about concepts and messages to promote mammography in these populations. The questions are a necessary part of the screening process to ensure (1) eligibility to participate and (2) that the focus groups are racially homogeneous to facilitate group interviewing. In addition, to minimize psychological distress to participants, 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.

Some respondents may find thinking about and discussing breast cancer unpleasant. The questions in the participant versions of the DIS (Attachment A1a, Attachment A1b, and Attachment A2) or moderator guides (Attachment J1, Attachment J2) ask about respondents’ opinions and thoughts about health, breast cancer, screening, and/or specific messages/materials and appropriateness. Questions about messages/materials are designed to determine if materials are clear and understandable to the target audience, are personally relevant to the target audience, have sensitive or controversial elements, capture the audience’s attention, match the audience’s preferences for wording and format, and confirm that selected settings and activities are appropriate. These questions are necessary in order to achieve the specific aims of this information collection. Participants will not be asked about their own personal health in focus groups.

A12. Estimates of Annualized Burden Hours and Costs

A. Burden for this effort is based on an 80% response rate (i.e., 80% of persons who are recruited to participate are eligible and agree to participate) for the focus groups. The recruitment screeners (Attachment E1, Attachment E2) will each take approximately 5 minutes to complete. Therefore, of the 225 women who are approached during recruitment for the 12 focus groups, a total of 180 (15 per group) will be eligible and agree to participate. These 180 eligible women will be scheduled to attend groups to account for attrition; however, only 120 women will actually participate in the groups in total (10 per group for the 12 groups). In addition, of the 180 eligible women scheduled to attend the focus groups, 20% (36 total, 3 per group) will be rescreened by CDC’s data collection contractor for quality assurance purposes. Eight of the 12 focus groups will be held with African-American women (see the discussion guide in Attachment J1), and four of the 12 focus groups will be held with Latinas (see the discussion guide in Attachment J2).

For African American women, participants in each focus group will complete a Pre-discussion Information Sheet (Pre-DIS) and a Post-discussion Information Sheet (Post-DIS). The Pre-DIS (Attachment A1a) will take approximately 10 minutes and will be administered prior to the start of the 90-minute focus group discussion. The Post-DIS (Attachment A1b) will take approximately 20 minutes and will be administered towards the end of the focus group discussion as part of the radio message testing section. This activity is managed as a continuous focus group data collection, so the total estimated burden per respondent is 2 hours, including the Pre-discussion and Post-discussion Information Sheets and the focus group discussion.

For Latina women, a Pre-Discussion Information Sheet will take approximately 30 minutes and will be administered at the start of the focus group discussion, which will last approximately 110 minutes. This activity is managed as a continuous focus group data collection, so the total estimated burden per respondent is 2 hours and 20 minutes, including the Pre-DIS and the focus group discussion.

Additionally, the Pre- and Post-discussion Information Sheets have been adapted/annotated solely for the moderator’s use (Attachment K). This Pre/Post-discussion Information Sheet does not entail additional burden to respondents.

For all information collection, the total estimated burden to respondents is 315 hours, as summarized in Table A12-A below.

Table A12-A. Estimated Annualized Burden to Respondents

Type of Respondent

Form Name

Number of Respondents

Number of Responses per Respondent

Average Burden per Response
(in hours)

Total Burden

(in hours)

African American women aged 40–64 years

Recruitment Screener (initial)

150

1

5/60

13

Recruitment Screener (spot-check)

24

1

5/60

2

Pre-discussion Information Sheet

80

1

10/60

13

Post-discussion Information Sheet

80

1

20/60

27

Focus Group Discussion Guide

80

1

90/60

160

Latinas aged 40–64 years

Recruitment Screener (initial)

75

1

5/60

6

Recruitment Screener (spot-check)

12

1

5/60

1

Pre-discussion Information Sheet

40

1

30/60

20

Focus Group Discussion Guide

40

1

110/60

73





Total

315



B. Table A12-B presents the calculations for cost of annualized burden hours. North Carolina State minimum hourly wage rate information is from the U.S. Department of Labor (http://www.nclabor.com/wh/fact%20sheets/minimum_wage_in_NC.htm) Web site. The total annualized respondent cost of burden hours is estimated at $ 1,995.

Table A12-B. Estimated Annualized Cost to Respondents

Type of Respondent

Form Name

Number of Respondents

Number of Responses per Respondent

Average Burden per Response
(in hours)

Average Hourly Wage

Total Cost

African American women aged 40–64 years

Recruitment Screener (initial)

150

1

5/60

$7.25

$91

Recruitment Screener (spot-check)

24

1

5/60

$7.25

$15

Pre-discussion Information Sheet

80

1

10/60

$7.25

$97

Post-discussion Information Sheet

80

1

20/60

$7.25

$193

Focus Group Discussion Guide

80

1

90/60

$7.25

$870

Latinas aged 40–64 years

Recruitment Screener (initial)

75

1

5/60

$7.25

$45

Recruitment Screener (spot-check)

12

1

5/60

$7.25

$7

Pre-discussion Information Sheet

40

1

30/60

$7.25

$145

Focus Group Discussion Guide

40

1

110/60

$7.25

$532






Total

$1,995




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

Respondents will incur no capital or maintenance costs to complete the collection of these data.

A14. Annualized Cost to the Government

Table A14 presents the costs to the Federal Government. Two types of Government costs will be incurred:

  1. Government personnel. The Technical Monitor is assigned for 50% of their FTE. Assuming an annual salary of $120,000 for the Technical Monitor, the total amount paid to Government personnel is $60,000.

  2. Contracted data collection. The project design and data collection is being conducted under a contract with CDC’s data collection contractor, ICR Macro. The current contract is for a total of $281,930 and includes costs for planning, conducting, and analyzing the focus groups.

Therefore, total annualized cost to the Federal Government for this data collection is $341,930.

Table A14. Estimates of Annualized Cost to the Government

Item

Annualized Cost

Technical Monitor at 50% of their FTE

$60,000

Contractor

$281,930

TOTAL

$341,930


A15. Explanation for Program Changes or Adjustments

This is a new data collection.

A16. Plans for Tabulation and Publication and Project Time Schedule


Plans for Tabulation and Publication

The focus group analysis plan was developed by taking into account the resources available for analysis, the anticipated quantity of data that will be generated from 12 focus groups, and the anticipated use of the findings. Data from the Pre-discussion and Post-discussion Information Sheets will be analyzed with SPSS, version 13.0. Pre-discussion and Post-discussion Information Sheet data will be entered into an SPSS database, and frequencies will be run for each of the questions on the Pre/Post-DIS. The resulting analyses will be used only as a means of describing the study participants and drawing comparisons between groups or segments. Data obtained from the Pre-discussion and Post-discussion Information Sheets will not be used to make generalizations about any larger population and will be reported and analyzed in aggregate form.

Once the focus groups are completed, the notetakers will analyze the field notes across the groups by research question, and for specific segments, and then they will prepare topline summaries that highlight emergent themes between and among segments. The research questions (RQ) for the focus groups with Latinas are as follows:

  • RQ1: What are thoughts about breast cancer, early detection, and screening for breast cancer?

  • RQ2: What factors influence women to participate or not in the NBCCEDP?

  • RQ3: What are viable ways (e.g., messages, sources, channels) to disseminate information about NBCCEDP services to women?


The RQs and subquestions for focus groups with African American women are as follows:

  • RQ1: What are thoughts about breast cancer, early detection, and screening for breast cancer?

  • RQ2: What are the general thoughts about intervention’s messages and materials?

    • What is the audience’s reaction to the messages and materials?

    • Are the messages and materials understandable and believable?

    • Do the messages and materials appeal to the audience?

    • How can the messages and materials be improved for this audience?

  • RQ3: What are the general thoughts about the intervention’s advertisements (ads)?

    • What is the audience’s initial reaction to the radio ads?

    • Do the radio ads catch the audience’s attention?

    • What does the audience think the radio ads are saying to them?

    • Are the radio ads understandable and believable?

    • How can the radio ads be improved for this audience?


A sample topline summary is attached (Attachment L). The topline summary will include terms such as “several” to describe focus group discussions. Other acceptable terms to use to describe participants’ comments and ideas include “some,” “many,” “most,” and “a few.” Setting numerical parameters to quantify terms such as “some,” “many,” “most,” and “a few” is not a standard practice when describing qualitative data and every attempt will be made to ensure that all comments and insights are reported in a consistent and accurate manner.

Project Time Schedule

Table A16-A presents the estimated timeline for conducting focus groups after receipt of OMB clearance. CDC plans to complete the focus group data collection before the end of the current OMB approval period for this generic clearance (OMB No. 0920-0800, exp. date 11/30/2011).

Table A16-A. Prototype Focus Group Schedule

Activity

Time Schedule

Identify and recruit focus group participants

1–2 weeks after OMB approval

Conduct focus groups

3–4 weeks after OMB approval

Analysis of focus group results (topline reports)

6 weeks after OMB approval

Prepare final report of all activities

2.5 months after OMB approval

Revise or develop final print materials and audio messages for radio directed at African American women as addendum to focus group report

5 months after OMB approval


Focus group findings will guide modifications to existing AAMM materials. In addition, the findings will be disseminated through presentations and/or posters at meetings and as publications in peer-reviewed journals. All abstracts, poster presentations, and manuscripts will undergo CDC clearance review before submission to conferences or journals.

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

An exemption to displaying the OMB expiration date is not being requested.

A18. Exemptions to Certification for Paperwork Reduction Act Submissions

Not applicable. No certification exemption is being sought.

References

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Centers for Disease Control and Prevention. (2010). National Breast and Cervical Cancer Early Detection Program: About the program. Atlanta, GA: Author. Retrieved August 19, 2010, from http://www.cdc.gov/cancer/nbccedp/about.htm#ac

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