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Scott D Ramsey



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    MA22 - Partnering with Patients to Understand Stigma, Disparities and Values Leading to Improved Lung Cancer Care (ID 154)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advocacy
    • Presentations: 1
    • Now Available
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      MA22.02 - The Impact of Patient Engagement on Study Design and Patient Recruitment in a Pragmatic Trial to Improve Cancer Care Delivery (Now Available) (ID 2388)

      15:45 - 17:15  |  Author(s): Scott D Ramsey

      • Abstract
      • Presentation
      • Slides

      Background

      SWOG trial S1415CD is a pragmatic study comparing outcomes of Colony Stimulating Factor (CSF) use in usual care with care that uses guideline-informed standing CSF orders. A 21-person External Stakeholder Advisory Group (ESAG), including 10 patient partners, has informed the design, implementation, recruitment and dissemination planning for the study. Recruitment has been a challenge for study sites, specifically around approaching and consenting patients in the window between diagnosis and first cycle of chemotherapy. This abstract explores the impact of the ESAG patient partners on the patient recruitment process for S1415CD.

      Method

      Patient partners are convened each year over monthly teleconferences, one in-person meeting and targeted email communication. Patient partner input from 2014-present has been tracked and reviewed for impact on the patient recruitment process. After the start of accrual in October 2016, a teleconference was held in spring 2017 focused on barriers to patient accrual, specifically patient approach. Study sites submit monthly screening logs detailing reasons for patient ineligibility.

      Result

      Prior to the start of accrual, patient partners collaborated with the research team to create 2 resources to assist clinic staff with presenting the trial in lay terms: a patient brochure and a summary handout for clinical research associates (CRAs). CRAs reported high use of the brochure as a valuable, simple tool for explaining the trial to eligible patients. Patient partners were also engaged in developing consent forms for trial participants. In addition, patient partners developed strategies for approaching patients in the timeframe between diagnosis and first cycle of chemotherapy which were compiled into a document for study sites and incorporated into the trial’s frequently asked questions. Between October 2016-June 2017, the approach and consent process (i.e. the inability to consent patients in the narrow timeframe) accounted for 22% of all reported ineligible patients, however after the implementation of patient-formulated strategies, during June 2017-December 2018, the approach and consent process has accounted for only 10% of all reported ineligible patients.

      Conclusion

      Sustained engagement and active participation of patient partners throughout S1415CD has provided unique experiential knowledge and feedback to improve the patient approach and consent process across study sites, leading to increased opportunities for patient recruitment. Engaging patient partners early and throughout the study design and conduct phases of the research has been successful in providing patient-centered solutions to recruitment and implementation challenges, including the challenge of timing, to ensure success in reaching the study accrual goals.

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    OA07 - Precision Medicine Involves Biology and Patients (ID 132)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      OA07.06 - Patient Knowledge and Expectations Related to Return of Genomic Results in the Lung-MAP (SWOG 1400) Biomarker-Driven Clinical Trial (Now Available) (ID 730)

      11:00 - 12:30  |  Author(s): Scott D Ramsey

      • Abstract
      • Presentation
      • Slides

      Background

      Biomarker-driven clinical trials (BDCTs)--where participants qualify for targeted therapy sub-studies based on tumor genomic testing results--represent a new paradigm in oncology clinical trials. However, BDCTs’ complex designs are difficult to communicate to patients considering participation, and deficits in knowledge and expectations have implications for shared decision-making and informed consent. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung-MAP (SWOG 1400) BDCT.

      Method

      From 8/2017 to 4/2019, we recruited a subset of participants with advanced non-small cell lung cancer (NSCLC) from among patients enrolled in the Lung-MAP genomic screening study (SWOG 1400). Participants completed a 38-item telephone survey conducted by trained staff within 30 days of consent. Survey questions assessed patient knowledge about the benefits and risks of study participation and expectations about return of genomic results in the study. The survey was structured as 5-level scale responses (‘strongly disagree’ [1] to ‘strongly agree’ [5]) and true/false/don’t know. Survey questions were adapted from prior studies that evaluated knowledge and expectations about return of genomic results. Descriptive statistics (means, medians, proportions) were assessed in this preliminary analysis.

      Result

      Among 123 participants, median age was 67, 61.0% were male, 95.1% were white, 22.0% had a 4-year college education or more, and 28.5% had a household income of <$25,000/year. In the overall sample, 82.9% ‘strongly/somewhat agreed’ with the statement ‘I received enough information about the testing in Lung-MAP to understand the benefits of enrolling’ and 73.2% ‘strongly/somewhat agreed’ with the statement ‘I received enough information…to understand the risks of enrolling’. Among the sub-group that ‘strongly/somewhat agreed’ with understanding trial benefits: 89.2% correctly believed that it was ‘true’ that test results would help to select their cancer treatment (8.8% responded ‘don’t know’), 8.8% correctly believed it was ‘false’ that the somatic testing in the study would provide information to find out if family members had increased risk of cancer (40.2% responded ‘don’t know’), and 11.8% correctly believed it was ‘false’ that results would tell them about their risk of developing diseases besides cancer (38.2% responded ‘don’t know’).

      Conclusion

      Among participants in a large BDCT, a majority of participants had serious deficits about the reporting of genomic results despite reporting to have enough information to understand benefits and risks. Our findings suggest that further research is needed to identify effective approaches to communicating information about BDCTs to improve patient knowledge about return of genomic results.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-30 - Impact of Patient TKI Copayments on Insurance Expenditure in Advanced EGFR or ALK Positive Non-Small Cell Lung Cancer (NSCLC) (ID 729)

      09:45 - 18:00  |  Author(s): Scott D Ramsey

      • Abstract

      Background

      To influence treatment choice and control expenditures, insurance plans impose cost sharing policies for expensive oral tyrosine kinase inhibitors (TKIs). We evaluated the effect of patient TKI copayments on insurance expenditures among patients with EGFR and ALK positive advanced NSCLC receiving TKIs.

      Method

      We identified EGFR+ and ALK+ NSCLC patients in the Washington State SEER registry using natural language processing on registry pathology reports, followed by manual confirmation of molecular test results. We linked registry records with commercial and Medicare claims. Eligible patients had stage IV NSCLC diagnosed between 01/01/2010 and 12/31/2016, EGFR exon 19 deletions or L858R mutations, or ALK + by FISH, 12 months of insurance enrollment, survival of 6 months, and 1 pharmacy claims for EGFR or ALK TKIs with FDA approval in the study period. We estimated monthly TKI copayments by subtracting the drug amount paid from the amount allowed by insurance in pharmacy claims. We used claims to calculate lifetime total and drug costs from the insurance perspective. Covariates included sociodemographic characteristics, insurance type, comorbidity, mutation type, and receipt of chemotherapy and immunotherapy. We used generalized linear models with gamma family and log link to estimate the adjusted effect of TKI copayment of $0 vs. above $0 on insurer expenditures in 2016 US dollars.

      Result

      Of 103 eligible patients, median age was 69; 66% were female; 72% were White, median household income was $69,951; 54% had Medicare, 85% were EGFR+, and 51% received chemotherapy or immunotherapy. Mean monthly TKI copayment was $312 (range= $0 to $5,913). Mean total and drug reimbursements were $234,294 and $114,253. Table 1 shows the adjusted effect of TKI copayments on insurance expenditures.

      Conclusion

      Higher TKI copayments were not associated with lower insurance expenditures. Eliminating TKI copayments would reduce patient financial burden and not adversely impact insurer spending.

      Table 1. Effect of Patient TKI Copayments on Insurance Expenditures, Adjusted for Age, Race, Comorbidity, Insurance Type, Mutation Type, Receipt of Chemotherapy and Immunotherapy (EGFR TKIs: erlotinib, gefitinib, afatinib, osimertinib; ALK TKIs: crizotinib, alectinib, ceritinib, brigatinib).
      TKI Copayment (n=103) Adjusted Mean Total Expenditure (95% CI) P value Adjusted Mean Drug Expenditure (95% CI) P value
      $0 (n=82) $230,989 ($188,958; $273,019) Ref. $110,171 ($88,150; $132,194) Ref.
      Above $0 (n=21) $264,963 ($182,424; $347,502) 0.44 $132,707 ($83,206; $182,208) 0.38