Development of an iphone app to manage surveillance in women with a BRCA mutation

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Julia Bryan
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1 Development of an iphone app to manage surveillance in women with a BRCA mutation Stephanie A. Cohen, MS, LCGC Genetic Counselor St. Vincent Hospital Indianapolis, IN

2 BRCA-Associated Cancers: Lifetime Risks breast cancer (~50-60 %) ovarian cancer (~15-45%) breast cancer (~6%) Prostate cancer (20%) Pancreatic ca and melanoma and?

4 How well are we doing?

6 Surveillance practices survey Mutation positive individuals FORCE Indianapolis chapter Ovar coming

7 Demographics 88 respondents 96% female 47% under the age of were BRCA + 56% BRCA1, 44% BRCA2 72% had testing in past 1-5 years

8 Self-reported breast screening practices among BRCA+ women who have not had bilateral mastectomy Reported Frequency Self breast exam (N=19) Clinical breast exam (N=20) Mammogram (N=19) Breast MRI (N=19) Once a month *21.1% (4) N/A N/A N/A Every % (7) N/A N/A N/A months Every 6 N/A *25% (5) 5.3% (1) 5.3% (1) months Annually 15.8% (3) *60% (12) *68.4% (13) *21.0% (4) Once every N/A 5% (1) 5.3% (1) 10.5% (2) few years Never 26.3% (5) 10% (2) 21% (4) 63.2% (12)

9 Self-reported ovarian screening practices among BRCA+ women with intact ovaries Reported Frequency Transvaginal US (N=11) CA-125 (N=11) Every 3 months N/A 9.1% (1) *Twice a year 18.2% (2) 18.2% (2) Once a year 27.3% (3) 27.3% (3) Once every few years 9.1% (1) 0 Never 36.4% (4) 45.5% (5)

10 Comparison with previous literature Study Peshkin (2002) Schwartz (2003) Botkin (2003) Schwartz (2011) Our data (2011) Women utilizing mammogram Women utilizing MRI CA-125 TVUS 68% N/A N/A N/A N/A N/A 43% 40% 62% (>1 yr) 57% (>2 yrs) 82% (unaffected) 92% (affected) N/A N/A N/A 46% (unaffected) 51% (affected) *56% *42% 67% 35% 76% 56% *only 24% (35/144) respondents had intact ovaries

11 Medical follow up BRCA carriers are not following NCCN guidelines Age? Lack of physician direction? Lack of access (insurance, geographic)? Perceived risk? # affected relatives/experience with cancer?

12 Goal project: Create a patient-oriented interactive tracking tool to monitor surveillance for BRCA carriers We hypothesize that introducing a tool will improve adherence to NCCN guidelines.

13 Plan Grant from NSGC Cancer SIG July 2013 Needs assessment (online survey) Aug 2013 Tool development June 2013 IRB approval July 2013 Focus Group: Patients and providers Sept- Oct 2013

14 Needs Assessment BRCA+ women with addresses in our database (n=68) 10 responses 7/10 had at least one breast and/or one ovary

15 What prevents you from doing your surveillance?

16 How do you remember to schedule an appointment? Calendar it into my phone to call to make the appointment I always schedule the next appointment after every visit They call me when it is time Calendar appointment I don t have anything regular except yearly GYN exams and annual internist exams

17 What would help you remember? If I could schedule all three appointments at each office visit for the next year Reminders are good A reminder or phone system reminder card

18 If there was a tool that would allow you to monitor your own health surveillance.what would you want included? An "alert" or reminder system, complete with the number I need to call to get the appointment scheduled, and an alarm notice that goes off regularly until I note that it has been done. Maybe a schedule to fill in when I see the doctor or have a test. Also a statistical sheet with ages and mutations and percentage of risks. check list, calendar, alogrithm

19 Focus groups 4 women with BRCA mutation 3 healthcare providers Guided discussion with two sample tools Binder format Electronic fillable/printable form

22 Patient perspective Liked Straightforward language Simplicity tool Organization Motivational phrases presented in positive manner Desired: More space for provider information Portability Consolidation of records Mobile application!

23 Mobile application with: Text reminders Link to iphone calendar with reminders Alerts for breast self-exams Updates for news releases (newly open research studies or clinical trials, new therapies or genetic testing that comes available, etc.) Able to automatically generate reminders for appropriate surveillance/management based on age of patient and what surgery already done Able to find local physicians who are experts in their field or aware of BRCA1/2

24 Providers Most had no mechanism for f/u Electronic would be better than paper App strongly perceived as useful, mobile, flexible Paper tool overwhelming Dangerous to leave it up to patients to track their own screening, but better than what we have now (nothing) Messaging might introduce fear

25 Provider suggestions Surgical intervention log Single page summary Signs/symptoms ovarian cancer More detailed description of concerning breast changes Annual messaging to talk to doctor about PBM/PBSO (age appropriate) Electronic version/app: Ability to have an reminder or add to calendar Ability to upload documents/connect with EMR Personalized/tailored messaging to patient

26 Why did we choose iphone? Seemed to be the likely choice: iphone and android are split in terms of ownership in the US But iphone users are more likely to use apps than Android users Most apps developed for iphone first Newsletter sent out to patients in the database 27% used outlook (likely on computers) 19% iphone 13% ipad 9% Android

27 Sept 2013 The work begins.

30 Respondent demographics 10/10 BRCA+ 6/10 had cancer 50% had testing >5 years ago 6/10 had at least one breast and/or ovary 6/10 had iphone

31 General demo feedback Liked the simplicity and organization Preference for open space to document Would access links (ie, FORCE) Feedback on graphics, colors and name

32 Specific demo feedback 1/7 mentioned concern about security of health information 4/9 said they would prefer iphone app over fillable electronic form 5/9 said they would use both iphone app and printable electronic record 0/9 would not use iphone app

33 Emotional responses to tool 0/10 said seeing the tool made them scared, worried anxious, nervous or stressed out 6/10 said seeing the tool made them feel less stressed 4/10 said it made them feel hopeful

34 Do you think the app or the on-line form would help you to get recommended screening on time? 9/10 said yes could be a good tool, moves a challenging process to a more routine instance (like getting a pap smear) everything in one location one stop shop yes because my phone is with me 24/7 no because my doctor schedules it all

35 Suggestions FAQ section Checklist Field for doctor contact information Place to write down questions Ability to export to Excel Expand to Android

36 The work continues

37 Some roadblocks. Grant from St. Vincent Foundation Legal review Feb 2014 Starting over Jan 2014 itunes issue March 2014

38 Moving along.. IT requirements Oct 2014 Contract/statement of work Dec 2014 June 2014 More resources Nov 2014 Regular development meetings with team

39 Finish line in sight.. Test phase July 2015 Legal approval Sept 2015 June 2015 FDA notification and NCCN approval Aug 2015 Video demo/final IRB amendments

40 Payoff..

41 App demo walk-through Indianapolis/Healthcare-Services/Cancer- Care/Screening-and-Diagnosis/Cancer- Genetics-Risk-Assessment.aspx

42 Final phase: Study of effectiveness Baseline survey: current surveillance practices, beliefs and use of technology Access code for iphone app and link to download iphone app from itunes store provided 18 months Follow-up survey: surveillance practices, beliefs and feedback on app

43 Enrollment criteria Be female Be at least 18 years old Carry a BRCA1 or BRCA2 mutation Have at least one breast and/or at least one ovary Have an iphone

44 Evaluation of analytic data How often is the app accessed? How often do users schedule an appointment to their native calendar? How often do users add details to their scheduled procedure (location, etc.) How often do users mark their procedure as complete? How often do users add details to their My progress page? How many times do users follow the link to the NCCN guidelines? How many times do users access the glossary? How many times to users access the My providers area? How many times do users add a new provider to the My providers page? How often do users edit their profile? What portion of the app do people spent the most time?

45 Final Product After 200 subjects have enrolled, app will be made publically available to those outside the study Results will be compiled and submitted for publication/presentation

48 SNAP to date Started advertising 10/2/ responses to baseline questionnaire 57 codes have been provided Target: 200

49 What we ve learned.. Clinical jargon and IT are very different IT FDA Some apps are considered medical devices Need for review for risks Legal Cost Development, graphics TIME

51 Acknowledgments: Team: Dawn Nixon, MS, LCGC and Courtney Scherr, PhD, Greg Nixon, Ascension Health Information Services, Intermark Interactive Prototype work: Eddie Roger (web design) and Bruce Lampe (graphic design)

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