#2 fast-track template Request_PCC_Usability

Request for Approval under the

“Generic Clearance for the Collection of Routine Customer Feedback” (NIH/OER)

(OMB Control Number: 0925-0648-2, Expiration Date 1/31/2015)

T ITLE OF INFORMATION COLLECTION: Usability Study for Patient-Centered Communication (PCC) Web-based Application for NCI

PURPOSE:

This project seeks to develop a web-based and cancer-based patient-focused system with the goal to facilitate communication and care for cancer patients. The main hub of the prototype is the patient portal. The patient portal provides the patient with a wealth of information and capabilities, such as: calendaring tools to keep track of treatment schedules and events; symptom assessments that enable symptom tracking over time and sharing this with their oncologist; educational materials; clinical trials; and decision aids. There is also a social networking function to this prototype that: allows the patient to invite their friends and family to interact and support him/her during the cancer journey; allows local support groups and recognized support organizations to post events that, if applicable, are presented to the patient; and provides the oncology care team with a way to receive symptom alerts and communicate with the patient. The overall idea is that by tying in all of these components into one system, the patient will empowered by the ability to quickly and easily access support and information relating to their cancer care. There are two phases, the initial phase is a requirements gathering to understand the expectations and needs from the patients, providers, and support people (caregivers, support group leaders, community support representatives, promotoras). The second phase involves usability testing.

Usability Testing – Phase 2

A component in creating a successful product is to ensure that the system is easy-to-use and meets the user’s expectations. The proposed usability tests will allow us to determine the usability of the product and to identify possible solutions to any problems. The usability tests will test multiple aspects of the user’s success with using this system, such as performance, accuracy, recall and emotional aspects. Usability testing will allow us to answer questions such as is it easy to use, how the user feels about the solution, and can the user find what they are looking for. Usability testing will combine qualitative and quantitative research methods. The methods are mainly qualitative, open to interpretation since interfaces have many 'moving parts' and users tend to experience them all at once. The quantitative methods involve asking the user to complete a usability survey (System Usability Scale - SUS) at the end of the usability testing experience.

DESCRIPTION OF RESPONDENTS:

Participants will include cancer patients and support persons (caregivers, support group leaders, community support representatives, promotoras). Inclusion criteria for patients are: must have had a cancer diagnosis within the past five years; must be aged 21 years or older; must speak and read English; and must be able to travel to the usability testing site. The inclusion criteria for the support people are: must have been responsible for the care and support of a cancer patient in the past five years; must be aged 21 years or older; must speak and read English; must be able to travel to the usability testing site.

Two rounds of usability tests will be conducted and each round will have 10 participants. Each participant will be interviewed individually and each interview will last approximately one hour. Participants will be asked to complete a series of pre-determined tasks that require the user to navigate through the website and find information or complete activities (such as reporting symptoms). After the participant completes the series of tasks, he/she will be asked to complete a usability and usefulness survey.

TYPE OF COLLECTION: (Check one)

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

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

[ ] Focus Group [ ] Other: ______________________

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: DerShung Yang

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

Personally Identifiable Information:

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

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

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

PII will not be collected by NCI or the contractor. A professional recruiting company will locate, identify, contact and schedule the participants for the usability testing.

Gifts or Payments:

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

A gratuity payment of $40 per patient and support person will be offered to the usability participants. The payment is meant to offset the costs of travel to/from the usability test site and time being absent from work.

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time	Burden
Individuals	20	60 mins	20 hours
Totals	20		20 hours

Total Burden Hours used for IC’s to date: 923

Total Burden Hours Approved for IC’s under 0925-0648: 148,072

Total Burden Hours currently requested: 20

FEDERAL COST: The estimated annual cost to the Federal government is __$29,790_____

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? [X] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)?

The recruitment will be accomplished through the use of a professional recruitment company that specializes in recruiting for usability testing. The sampling plan will be to enroll those who qualify given inclusion/exclusion criteria in the order that they are found and can participate. Once the number per group has been met, the recruitment will stop.

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

[ ] Mail

[ ] Other, Explain

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

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

Attachments 1-4: Phase 1 – Requirements Gathering

Attachment 5: Phases 1 and 2 - Mock Ups of Website

Attachments 6-10: Phase 2 – Usability Testing

Attachment 6: Usability Protocol for Patient

Attachment 7: Usability Protocol for Support People

Attachment 8: System Usability Study (SUS)

Attachment 9: Consent Form for Patient

Attachment 10: Consent Form for Support People

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