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1、I-SPY2 Recruitment&Retention Plan,Draft-September,2009,Randomize,Agree?,Make Patients Aware of Trial,Enroll&Start Treatment,Screening Consent Discussion,Interest?,Eligible?,Agree?,Done,Treatment Consent Discussion,Yes,Yes,No,Yes,No,Yes,No,Non-Eligibility Letter,Decline Questionnaire,I-SPY2 Patient P
2、ortfolio,Decline Questionnaire,Optional Peer Support Call,Peer Support Call(s),Done?,Congratu-tions Letter,No,Yes,Welcome Letter,I-SPY2 Brochure,Recruitment&Retention Interface,Exit Interview,Dropped Out,No,I-SPY2 Patient Website,I-SPY2 Patient Website,I-SPY2 Patient Website,RecruitmentPromotionCons
3、enting PatientsOverall Recruitment ExpectationsDiversity ConsiderationsTracking AccrualPatient Decline QuestionnaireRetentionPatient Materials/WebsiteNetwork of Strength HotlineSite Specific SupportExit Questionnaire,Table of Contents,Trial Site Education Sessions,especially with surgeonsAdvocacy an
4、d Clinical Trials WebsitesEducational Sessions and Materials for Breast Cancer HotlinesNational Scientific and Advocacy Education SessionsLocal and National Press ReleaseLocal and National Press,TV,&Radio InterviewsLocal and National Advocate PresentationsScientific and Patient PublicationsBroad Dis
5、tribution of I-SPY2 Brochure,Promotion,See draft brochure,I-SPY2 Brochure,Informed Consent documents have undergone careful review by a large number of experienced advocatesTraining will be developed to reinforce best practices in consenting and summarize I-SPY2 specific informationFAQ questions wil
6、l be made available to consentersPatient website will have fact sheets,patient schedules,and other relevant information available as PDFs to support consenting process,Consenting Patients,Overall Recruitment Expectations,Goal:Summing over trial sites,I-SPY2 patients should reflect the diversity of U
7、S women affected by breast cancerActions:Travel reimbursement for research visitsProactive recruitment of trial sites that over represent minoritiesIdentify potential affiliate and/or satellite hospitals that might partner with main I-SPY2 sitesProactive recruitment of patients from under represente
8、d minoritiesTargeted advocacy organizations(e.g.,ICC)Targeted community outreachTargeted publications,Diversity Considerations,Actions Continued:Develop and deliver culturally sensitive and targeted workshops on participation in clinical trials in general and I-SPY2 in particularEnsure that all of o
9、ur patient materials are culturally sensitive and include pictures that reflect diverse populationsTranslate the Informed Consent and Recruiting Brochure into Spanish and/or other languagesIdentify language translation services that are available at each siteIdentify potential affiliate and/or satel
10、lite hospitals that might partner with main I-SPY2 sites,Diversity Considerations,Accrual by EEO Category(Assumes Discount Factor=35%),Quarterly by Trial SiteWhich sites are exceeding expectations?What can we learn from them?Which sites are failing to meet expectations?How can we remedy this?Quarter
11、ly by Patient Biomarker Profile and Treatment PlanBi-annually for adequate diversity,Tracking,Rapidly Diagnosing&Remedying Accrual Problems:Number of Patients,Rapidly Diagnosing&Remedying Accrual Problems:Distribution of Patients,Quarterly Tracking By Trial Site(Assumes Discount Factor of 35%,Quarte
12、rly Tracking By Biomarker Profile,Quarterly Tracking By Treatment,Bi-annual Diversity Tracking,Decline Questionnaire,See draft Decline Questionnaire,RecruitmentPromotionConsenting PatientsOverall Recruitment ExpectationsDiversity ConsiderationsTrackingPatient Decline QuestionnaireRetentionPatient Ma
13、terials/WebsiteNetwork of Strength HotlineSite Specific SupportExit Questionnaire,Table of Contents,Recruiting BrochureNew Patient PortfolioWebsite PDFsFact SheetsPatient ScheduleTrial Site Map,Support Services,Contact InformationPeer to Peer Letters,Patient Materials,The right amount of the right i
14、nformation at the right timeEasy to navigateAttractivewhite space,picturesText and FAQsPDF of key pages for use by trial site staff,Patient Website Requirements,See Prototypehttp:/gemini-,I-SPY2 Patient Website,24x7 toll free hotline Staffed by trained and certified breast cancer survivorsFree to ca
15、llersSpanish speaking counselorsInterpretation available in over 150 languagesE-mail optionMatch programsPatient specific requests(e.g.,diagnosis,treatment,demographics)Male breast cancer matchesPartners match program,Network of Strength Hotline(formerly Y-ME),Screening and Treatment Informed Consen
16、t Forms request permission for Network of Strength counselor to call patientPatient may,alternatively,take number and call if and when they pleaseA select group of experiences counselors will be specifically trained about I-SPY2(based on I-SPY2 Website)Supporting,but not pressuring patients,who are
17、considering enrollmentChecking in on,encouraging,and supporting patients who are undergoing treatment,I-SPY2 Use of Network of Strength Hotline,Website will provide site specific informationMapsHospital investigators and contact informationHospital services and contact informationLocally available a
18、dvocacy and support groupsEncourage all sites to maintain regular communication with patients and continuous express appreciation for participations in I-SPY2Optionally,local advocates will be identified to work with investigators at specific trial sites,Site Specific Support,Finalized Recruiting Br
19、ochureDevelop detailed PR plan and piecesDevelop training for consentersReassess accrual assumptionsObtain site-specific recruitment,accrual,and diversity expectationsFinalize tracking reports and data collection planFinalize data collection and analysis plans for patient declines,Follow-up,Ensure c
20、onformance of Informed Consent documents and planHot-line supportDecline questionnaireFollow-up on Patient WebsiteFinalize materialConstruct sitePilot test with advocatesFollow-up on Hot-lineFinalize budgetNegotiate termsSelect counselorsDevelop and deliver trainingDevelop Site Specific Support information,Follow-up(continued),
