Share Thoughts on Breast Cancer Study Overview and Statement of Work GPC Global Webinar, December 18,

Review the Share Thoughts on Breast Cancer Study statement of work  Aims, Design, Survey domains, Protocol Outline  SOPs Review pressure points in the timeline  IRB reliance request by Dec 23 (key personnel for all sites required), approval by Jan 23  IRB application by Jan 27, approval by Mar 16  First survey mailing April 28 Near-term deadlines  Name Study Team Point of Contact (POC) (Dec 19)  Complete the Site Preparation Questionnaire #1 (Dec 22) Outline

Specific aims encompass cohort characterization (n~4,500) and survey (completed n=1,000 or ~115 per Center) – Aim 1 – Select a cohort – Aim 2 – Demonstrate ability for semi-centralized questionnaire – Aim 3 – Generate pilot data (PROs, out-of-system care, correspondence of i2b2-derived measures w/ self-report) – Aim 4 – Determine prevalence of characteristics and validate algorithms in underlying cohort – Aim 5 – Demonstrate linkage of survey and i2b2- derived data for consenting patients Breast Cancer Cohort Study

The role of patient preferences and shared decision-making in management decisions associated with high inter-institutional variability What do patients know about their breast reconstruction options? Which patients receive autologous fat grafting? Prevalence and correlates of long-term effects – upper limb morbidity, neuropathy, heart failure, fatigue Outcomes of bilateral mastectomy Prevalence and correlates of gene testing Share Thoughts on Breast Cancer Sample Paper Topics

Cross-sectional survey months after diagnosis – Patient-reported outcomes FACT-B, Quick DASH, neuropathy, heart failure, shoulder diagnoses, fear of recurrence – BMI change – Treatments and interventions received including genetic testing, survivorship care plan elements and breast reconstruction – Factors considered when making surgery, chemo decisions – Shared decision-making x treatment type – Preferred decision-making role – Patient experiences of care (Care coordination and physician communication) – Recalled decisional uncertainty and decision support, perceived decision effectiveness – Interest in research participation Share Thoughts on Breast Cancer Survey Domains

Selection Criteria Inclusion criteria for the UNDERLYING de-identified study population: – Any sex – Diagnosed with primary breast cancer – Age 18+ at the time of dx – diagnosed during 7/1/ /30/2013 (i.e months prior to survey) (if there are insufficient patients diagnosed in this period, we may extend the window) Also, as the timeline for survey implementation slips we will shift the diagnosis window accordingly Exclude from the SURVEY sample if: – Sex not equal to female – Less than 18 years of age – Prior cancer diagnosis – Breast cancer was not microscopically confirmed – Only tumor morphology was lobular carcinoma in situ – Stage IV breast cancer – Known to be deceased – Non-English speaking (for now)

1.CC creates Survey Sample Finder File (see Work Plan 1). Site Honest Brokers append a study ID number (a range of ID numbers will be specified by the CC) and the MRN to the finder file and retain this file for later data requests for consented patients. 2.Site Honest Broker retrieves name and mailing address and supplies a file to site study team containing name, address, and encrypted MRN ID for mail merge. 3.Sites verify list by working with local tumor registrar 4.Each site will maintain a tracking database (likely via REDCap) that will include name, address, and study ID number. 5.Sites will send out a packet of information to potential subjects inviting them to enroll in the study. The packet will include, (a) a signed cover letter from the participating site on site appropriate letterhead, (b) the study questionnaire which will include an information sheet containing elements of consent on the inside front cover; (c) a consent document for obtaining medical record data at the end of the study booklet; (d) a $10 gift card; e) a copy of the consent document for their records; and f) a business reply envelope in which to return the study booklet. 6.Return of a questionnaire will indicate a willingness to participate in that portion of the study. 7.Return of the consent documents will be required for potential subject to be included in the i2b2 medical information part of the study. 8.Return of blank questionnaire will indicate a potential subject has declined to participate. 9.If a subject does not respond at all to the first mailing, one repeat mailing of the invitation packet will occur. Proposed Enrollment and Consent Process

1.Prospective subjects will be asked to complete a mailed questionnaire. The questionnaire should take about 30 minutes to complete. 2.They will also be asked to sign and return the consent document. 3.Both items will be included in one study booklet. The study booklet may be returned in a pre-paid envelope provided. The reply envelope will be addressed to the UI Coordinating Center. 4.The UI Coordinating Center project manager will optically scan the paper questionnaires and may telephone a participant if markings are not legible or ambiguous. The project manager will detach the consent forms and contact information from the study booklet and store them separately from the paper questionnaire pages. 5.The tracking database will be regularly updated with status of the questionnaire and consent. 6.A file containing study ID numbers for consenting individuals will be supplied to the participating sites. 7.Participating sites will generate i2b2 study variables for all consented subjects and submit to the study team via the GPC Honest Broker. 8.Coordinating Center will supply survey data for consented subjects back to the sites. 9.There is no long-term follow-up planned at this time. Other Study Procedures

SOP for Data Request, Transfer and Storage – 4 work plans: – WP1: create the survey sample finder file This work plan is necessary to validate the cohort eligibility criteria are comparably defined and applied. – WP2: Data support for mailings This work plan specifies how sites generate mailing list and conduct initial and non-respondent mailings and how response is tracked – WP3: Store survey dataset This work plan stores the survey data in the study database and uploads survey data for consented subjects back to the sites. – WP4: Request and obtain data for consented subjects This work plan is needed to complete the aims for the study and describes how the research team can access the complete study database for analysis. List of SOPs drafted

GPC Breast Cancer Survey Site preparation Questionnaires – These are necessary to insure that sites understand all tasks that will be required and have identified staff for each task GPC Breast Cancer Survey Mailing Protocol – This specifies many of the detailed procedures sites and the CC will follow. List of SOPs drafted (continued)

December 18 – GPC Site PIs Review scope of work December 19 – GPC Site PIs name the Study Team Point of Contact (POC) for your site – – Per IRB Reliance Agreement: “Site study teams will be asked to provide a point person for each site involved in the study to serve as the primary point person for the IRB review process for that site.” – Could be your site’s GPC Breast Group representative or a staff person in charge of the site’s survey implementation December 22 – Complete the Site Preparation Questionnaire #1 Near-term Deadlines