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1、I-SPY2 Recruitment & I-SPY2 Recruitment & Retention PlanRetention PlanDraft - September, 2009RandomizeRandomizeAgree?Agree?Make Patients Make Patients Aware of TrialAware of TrialEnroll &Enroll &Start TreatmentStart TreatmentScreening Screening Consent Consent DiscussionDiscussionInterestInterest? ?
2、Eligible?Eligible?Agree?Agree?DoneDoneTreatment Treatment Consent Consent DiscussionDiscussionYesYesYesYesNoNoYesYesNoNoYesYesNoNoNon-Eligibility Non-Eligibility LetterLetterDecline Decline QuestionnaireQuestionnaireI-SPY2 Patient I-SPY2 Patient PortfolioPortfolioDecline Decline QuestionnaireQuestio
3、nnaireOptional Peer Optional Peer Support CallSupport CallPeer Support Peer Support Call (s)Call (s)Done?Done?Congratu-Congratu-tions Lettertions LetterNoNoYesYesWelcome LetterWelcome LetterI-SPY2 I-SPY2 BrochureBrochureRecruitment & Retention InterfaceRecruitment & Retention InterfaceExit Interview
4、Exit InterviewDropped OutDropped OutNoNoI-SPY2 Patient I-SPY2 Patient WebsiteWebsiteI-SPY2 Patient I-SPY2 Patient WebsiteWebsiteI-SPY2 Patient I-SPY2 Patient WebsiteWebsiteRecruitmentRecruitmentPromotionPromotionConsenting PatientsConsenting PatientsOverall Recruitment ExpectationsOverall Recruitmen
5、t ExpectationsDiversity ConsiderationsDiversity ConsiderationsTracking AccrualTracking AccrualPatient Decline QuestionnairePatient Decline QuestionnaireRetentionPatient Materials/WebsiteNetwork of Strength HotlineSite Specific SupportExit QuestionnaireTable of ContentsTable of ContentsTrial Site Edu
6、cation Sessions, especially with surgeonsAdvocacy and 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 Pr
7、esentationsScientific and Patient PublicationsBroad Distribution of I-SPY2 BrochurePromotionPromotionSee draft brochureI-SPY2 BrochureI-SPY2 BrochureInformed Consent documents have undergone careful review by a large number of experienced advocatesTraining will be developed to reinforce best practic
8、es in consenting and summarize I-SPY2 specific informationFAQ questions will be made available to consentersPatient website will have fact sheets, patient schedules, and other relevant information available as PDFs to support consenting processConsenting PatientsConsenting PatientsOverall Recruitmen
9、t ExpectationsOverall Recruitment ExpectationsGoal: Goal: Summing over trial sites, I-SPY2 patients should reflect the diversity of US women affected by breast cancerActions:Actions:Travel reimbursement for research visitsProactive recruitment of trial sites that over represent minoritiesIdentify po
10、tential affiliate and/or satellite hospitals that might partner with main I-SPY2 sitesProactive recruitment of patients from under represented minoritiesTargeted advocacy organizations (e.g., ICC)Targeted community outreachTargeted publicationsDiversity ConsiderationsDiversity ConsiderationsActions
11、Continued: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 our patient materials are culturally sensitive and include pictures that reflect diverse populationsTranslate the Info
12、rmed Consent and Recruiting Brochure into Spanish and/or other languagesIdentify language translation services that are available at each siteIdentify potential affiliate and/or satellite hospitals that might partner with main I-SPY2 sitesDiversity ConsiderationsDiversity ConsiderationsAccrual by EE
13、O CategoryAccrual by EEO Category(Assumes Discount Factor = 35%)(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?Quarterly by Patient Biomarker Profile and Tr
14、eatment PlanBi-annually for adequate diversityTrackingTrackingProblemPotential SolutionToo few patients are offered trialEducate clinicians at trial sitesRecruit more trial sitesIncrease national publicityToo many patients decline screening consentEducate consentersImprove patient materialAssess rea
15、sons for declineToo many patients decline treatment consentEducate consentersImprove patient materialAssess reasons for declineLook for variation by treatment armRapidly Diagnosing & Remedying Rapidly Diagnosing & Remedying Accrual Problems:Accrual Problems:Number of PatientsNumber of PatientsProble
16、mPotential SolutionDistribution of patients by biomarker profile does not reflect distribution in populationIdentify competing trials for specific profiles at specific sitesOver recruit from other sitesDistribution of patients declining treatment varies by treatment assignmentClarify whether the iss
17、ue is based on rejecting standard of care or a particular investigational agentConsider over recruiting controls and/or dropping problematic investigational agentsInadequate diversityRecruit sites in more diverse communitiesIncrease targeted promotionRapidly Diagnosing & Remedying Rapidly Diagnosing
18、 & Remedying Accrual Problems:Accrual Problems: Distribution of Patients Distribution of PatientsQuarterly Tracking By Trial SiteQuarterly Tracking By Trial Site(Assumes Discount Factor of 35%(Assumes Discount Factor of 35%Quarterly Tracking By Biomarker Quarterly Tracking By Biomarker ProfileProfil
19、eQuarterly Tracking By TreatmentQuarterly Tracking By TreatmentBi-annual Diversity TrackingBi-annual Diversity TrackingDecline QuestionnaireDecline QuestionnaireSee draft Decline QuestionnaireRecruitmentRecruitmentPromotionPromotionConsenting PatientsConsenting PatientsOverall Recruitment Expectatio
20、nsOverall Recruitment ExpectationsDiversity ConsiderationsDiversity ConsiderationsTrackingTrackingPatient Decline QuestionnairePatient Decline QuestionnaireRetentionRetentionPatient Materials/WebsitePatient Materials/WebsiteNetwork of Strength HotlineNetwork of Strength HotlineSite Specific SupportS
21、ite Specific SupportExit QuestionnaireExit QuestionnaireTable of ContentsTable of ContentsRecruiting BrochureRecruiting BrochureNew Patient PortfolioNew Patient PortfolioWebsite PDFsWebsite PDFsFact SheetsFact SheetsPatient SchedulePatient ScheduleTrial Site Map, Support Services, Contact Trial Site
22、 Map, Support Services, Contact InformationInformationPeer to Peer LettersPeer to Peer LettersPatient MaterialsPatient MaterialsThe right amount of the right information at The right amount of the right information at the right timethe right timeEasy to navigateEasy to navigateAttractivewhite space,
23、 picturesAttractivewhite space, picturesText and FAQsText and FAQsPDF of key pages for use by trial site staffPDF of key pages for use by trial site staffPatient Website RequirementsPatient Website RequirementsSee Prototypehttp:/gemini- I-SPY2 Patient WebsiteI-SPY2 Patient Website24x7 toll free hotl
24、ine Staffed by trained and certified breast cancer survivorsFree to callersSpanish speaking counselorsInterpretation available in over 150 languagesE-mail optionMatch programsPatient specific requests (e.g., diagnosis, treatment, demographics)Male breast cancer matchesPartners match programNetwork o
25、f Strength Hotline Network of Strength Hotline (formerly Y-ME)(formerly Y-ME)Screening and Treatment Informed Consent 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 counse
26、lors will be specifically trained about I-SPY2 (based on I-SPY2 Website)Supporting, but not pressuring patients, who are considering enrollmentChecking in on, encouraging, and supporting patients who are undergoing treatmentI-SPY2 Use of Network of Strength I-SPY2 Use of Network of Strength Hotline
27、Hotline Website will provide site specific informationMapsHospital investigators and contact informationHospital services and contact informationLocally available advocacy and support groupsEncourage all sites to maintain regular communication with patients and continuous express appreciation for pa
28、rticipations in I-SPY2Optionally, local advocates will be identified to work with investigators at specific trial sitesSite Specific SupportSite Specific SupportFinalized Recruiting BrochureDevelop detailed PR plan and piecesDevelop training for consentersReassess accrual assumptionsObtain site-spec
29、ific recruitment, accrual, and diversity expectationsFinalize tracking reports and data collection planFinalize data collection and analysis plans for patient declinesFollow-upFollow-upEnsure conformance 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 informationFollow-up (continued)Follow-up (continued)
