Share Thoughts on Breast Cancer Study
Overview and Statement of Work
GPC Global Webinar, December 18, 2014
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Outline
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)
Breast Cancer Cohort Study
• 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 i2b2derived data for consenting patients
Share Thoughts on Breast Cancer
Sample Paper Topics
• 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 Survey Domains
• Cross-sectional survey 18-30 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
Selection Criteria
• Inclusion criteria for the UNDERLYING de-identified study population:
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Any sex
Diagnosed with primary breast cancer
Age 18+ at the time of dx
diagnosed during 7/1/2012 - 6/30/2013 (i.e. 18-30 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:
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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)
Proposed Enrollment and Consent Process
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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.
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.
Sites verify list by working with local tumor registrar
Each site will maintain a tracking database (likely via REDCap) that will include name, address, and
study ID number.
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.
Return of a questionnaire will indicate a willingness to participate in that portion of the study.
Return of the consent documents will be required for potential subject to be included in the i2b2
medical information part of the study.
Return of blank questionnaire will indicate a potential subject has declined to participate.
If a subject does not respond at all to the first mailing, one repeat mailing of the invitation packet
will occur.
Other Study Procedures
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Prospective subjects will be asked to complete a mailed questionnaire. The questionnaire
should take about 30 minutes to complete.
They will also be asked to sign and return the consent document.
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.
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.
The tracking database will be regularly updated with status of the questionnaire and
consent.
A file containing study ID numbers for consenting individuals will be supplied to the
participating sites.
Participating sites will generate i2b2 study variables for all consented subjects and submit to
the study team via the GPC Honest Broker.
Coordinating Center will supply survey data for consented subjects back to the sites.
There is no long-term follow-up planned at this time.
List of SOPs drafted
• 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 (continued)
• 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.
Near-term Deadlines
• 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