#4_Fast-Track Request_Solar Cell RD_Part 2_1-25-2012

Request for Approval under the

“Generic Clearance for the Collection of Routine Customer Feedback” (NCI)

(OMB Control Number: 0925-0642-04, Expiration Date 9/30/2014)

T ITLE OF INFORMATION COLLECTION: Multi-Part Plan for Research and Development of the Solar Cell Mobile Application: Part 2 (Cognitive Interviews)

PURPOSE:

The overall goal of the study is to design a smart phone application, Solar Cell, which uses smart phone technology to aid users in protecting their skin from damaging ultraviolet radiation (UV) in sunlight, a primary cause of skin cancer. NCI purposes to conduct, through a contractor, a multiple-part testing design that includes software usability testing and testing of the concept and mobile application as well as determining predictive algorithms. The results of these analyses will lend themselves to changes and modifications in preparation for the larger, randomized trial (a new, full OMB submission will be forthcoming). The parts may not be conducted one after the other, but may occur simultaneously (Study Diagram in Attachment 1).

Part 2: Cognitive Interviewing

The cognitive interviewing will be conducted to assure that the pre and posttest evaluation survey questions are clear and easily understood. Part 2 will test comprehension and timing of the pre- and post-test evaluation survey questions, as well as evaluate whether the questions are effective in gathering the needed information in preparation for the randomized trial. The pretest and posttest surveys assess sunburn prevalence (primary outcome), frequency of sun protection behavior (secondary outcome), theoretical mediators of personal sun protection (outcome expectations, self-efficacy, and intentions for sun safety), and potential moderators (demographics, skin type, skin cancer history, norms for sun safety and tanning image) (Attachments 3 and 4).

DESCRIPTION OF RESPONDENTS:

Eligibility criteria for respondents to participate will be:

a) being 18 or older,

b) being proficient in English, and

d) consenting to participate,

Exclusion criteria include being unable to read English and being under the age of 18.

TYPE OF COLLECTION: (Check one) If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ ] Small Discussion Group

[ ] Focus Group [x] Other: Cognitive Interviews

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name: ____Patricia Weber, DrPH - NCI

To assist review, please provide answers to the following question:

Personally Identifiable Information:.

1. Is personally identifiable information (PII) collected? [ x ] Yes [ ] No

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? [ x] Yes [ ] No

3. If Yes, has an up-to-date System of Records Notice (SORN) been published? [ ]Yes [X] No

PII is collected in the form of name, phone number, email, age, and race/ethnicity. This information is only used for contact purposes to schedule the meeting time.

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [x] Yes [ ] No

The participants will receive $40 as an expression of gratitude for their time and input. In the past, cognitive interview participants have received $40 in the past OMB approved sub-study #0925-0589-09, approved 2/2011. So participants in the study will be receiving on par with what NCI typically uses as an incentive for participants based on the type of collection and the type of participants.

BURDEN HOURS (for Parts 1-5 of sub-study)

Category of Respondent	Parts	No. of Respondents	Participation Time	Burden Hours
Individuals	SCREENER FOR ALL PARTS	150	5 minutes	13
	PART 1- BETA Testing	10	60 minutes	10
	PART 2- COGNiTIVE interviews	5	60 minutes	5
	PART 2- Focus Group	10	60 minutes	10
	PART 2- MEDICAL PROF. Interviews	10	60 minutes	10
	PART 2- Usability Testing	10	120 minutes	20
	Totals	195		68

Total Burden Hours used for IC’s to date: 47

Total Burden Hours Approved for IC’s under 0925-0642: 8750

Total Burden Hours currently requested: 68

FEDERAL COST:

The estimated annual cost to the Federal government is estimated to cost $4,900 to conduct Parts 1 through 5, as described above.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [x] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

For the cognitive interviews, participants will be recruited through investigators’ community contacts.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[x] In-person (COGNITIVE INTERVIEWS)

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [x] Yes [ ] No

List of instruments, instructions, and scripts submitted with this request:

Part 2: Cognitive Interview

Attachment 3: Consent Form

Attachment 4: Screening Script, Pretest Survey with Probes, and Posttest Survey with Probes

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