#4_Fast-Track Request_Solar Cell RD_Part 4_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 4 (Medical Professionals’ 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 4: Medical Professional Interviews

Parts 3 through 5 explore advice on when it is safe to be out in the sun (focus groups and medical professional’s interviews) and assure that the mobile application can be used outdoors (Android usability testing). Part 4 will include interviews with medical professionals to explore issues related to developing a predictive algorithm, and whether it is possible to provide advice on when it is safe to go out in the sun without sun protection. The interviews will focus on a) advice physicians give patients regarding sun exposure, sun protection, and vitamin D, b) their rationale for giving such advice, and c) under what conditions they would consider it safe for their patients to go out in the sun without sun protection (Attachments 7 and 8).

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.

Additional eligibility criteria for the:

• Medical professional interview participants will be: being a board-certified dermatologist, primary care physician, melanoma oncologist or dermatology nurse. 

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: 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 medical professional interview participants will receive $40 as an expression of gratitude for their time and input. In-depth interviews of physicians and other health care providers have received anywhere from $100-$150 to participate (OMB No. 0925-0046-03, approved 10/2010; OMB No. 0925-0589-02, approved 8/2010), with an average of $125. So participants in the study will be receiving below 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 (for Parts 1-5): 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?

The medical professionals will be recruited by Dr. Berwick and Dr. Dellavalle. Dr. Berwick, Ph.D., MPH is a Professor of Epidemiology and Associate Director for Population Science at the skin cancer clinic at the University of New Mexico Cancer Center. Dr. Dellavalle is an Associate Professor of Dermatologist at the School of Medicine, University of Colorado.

Administration of the Instrument

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

[ ] Web-based or other forms of Social Media

[x] Telephone (mEDICAL PROFESSIONAL Interviews)

[ ] In-person

[ ] Mail

[ ] Other, Explain

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

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

Part 4: Medical Professional Interviews

Attachment 7: Consent Form

Attachment 8: Discussion Guide/Questions

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