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Measuring the Feasibility and Cost of PRO-CTCAE Implementation in Trials Presentation to NCI Stakeholders

Measuring the Feasibility and Cost of PRO-CTCAE Implementation in Trials Presentation to NCI Stakeholders. Based on work of the PRO-CTCAE Task 8 (Feasibility) Committee October 5, 2011. Outline. Background Rationale Data sources: Correlative studies in cooperative group clinical trials

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Measuring the Feasibility and Cost of PRO-CTCAE Implementation in Trials Presentation to NCI Stakeholders

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  1. Measuring the Feasibility and Cost of PRO-CTCAE Implementation in TrialsPresentation to NCI Stakeholders Based on work of the PRO-CTCAE Task 8 (Feasibility) Committee October 5, 2011

  2. Outline • Background • Rationale • Data sources: Correlative studies in cooperative group clinical trials • Approach to measuring feasibility • Approach to measuring cost

  3. PRO-CTCAE Background • Contract I (2008-2010) + ARRA (2010-2012) • Items developed • Cognitive interviewing complete • Validation study 90% complete • Web software developed • Usability testing conducted to revise software

  4. PRO-CTCAE Background • Contract II (2010-2015) • Expand accessibility to patients • Develop IVRS • Spanish translation and linguistic validation • Determine optimal approach to clinician and patient AE reporting in cancer clinical trials • Assess feasibility and cost of implementation in cooperative group clinical trials

  5. Rationale for Assessing Feasibility/Cost • Towards future, need to understand feasibility and cost of implementing PRO-CTCAE in clinical trials at: • NCI level, Group level, Site/staff level (CRA and investigator), patient level • Including level of acceptance/enthusiasm at each level; barriers/effective strategies and infrastructure, effort, cost • Can inform modifications of approach, strategic decisions, resource allocation

  6. Data Source: Correlative Studies in 2 Clinical Trials • RTOG 1012 (Manuka honey) • Randomized phase II symptom intervention trial • Primary outcome: Improvement of esophagitis-related pain during RT for lung cancer • PRO-CTCAE completed weekly by iPad in clinic, with backup data collection methods • Status: Activation 10/19/11 • Alliance/NCCTG 1048 (rectal cancer) • Phase II/III trial • Hypothesis: neoadjuvant FOLFOX and restaging can risk stratify patients to selectively avoid combined modality therapy (CMT) before low anterior resection (LAR) with similar outcomes to CMT + LAR • PRO-CTCAE completed weekly by IVRS from home, with backup data collection methods • Status: CTEP review

  7. Additional Studies Outside of Contract • PRO-CTCAE is being integrated into several Alliance and RTOG trials as an exploratory endpoint by enthusiastic investigators • Material Transfer Agreement (MTA) mechanism developed • Permitting investigator-initiated research • Supporting R01 and R21 applications

  8. What Do We Mean By Feasibility and Cost? • Feasibility • Willingness and ability of stakeholders/entities at each level to integrate PRO-CTCAE into trials • Cost • Resources required at each level to implement PRO-CTCAE, including personnel effort, equipment, services

  9. Measuring Feasibility: NCI Level • System hosting • Logistics, technical difficulties, troubleshooting • Descriptive approach

  10. Measuring Feasibility: Group Level • Descriptive approach • Willingness to integrate into trials • Leadership • Clinical committees/Study Chairs • Concept review committees • Feasibility of integrating into protocols • Investigators • Protocol editors • Statisticians • Preliminary • Highly feasible, increasing interest to use PRO-CTCAE • Reflected in survey

  11. Feasibility: Site/Staff Level Staff feedback survey/semi-structured interviews • Training and central coordination • Ability to centrally train and coordinate staff • Ability to train patients • Patient enrollment • Proportion of eligible patients enrolled • Reasons for non-enrollment • Technical issues • Also assessed in usability and validation studies • Logistical barriers and recommendations SEE ATTACHED SURVEYS

  12. Feasibility: Patient Level • Proportion of patients willing to participate • Reasons for non-participation • Associated patient characteristics • Proportion of enrolled patients using the system at each time point • Reasons for non-adherence • Associated patient characteristics

  13. Cost Diagram COST NCI Level Cooperative Group Level Site Level • Hosting • Web • IVRS • Operations and maintenance • Technical support • System super admin • System improvements • CRAs • Teach patients • Monitor compliance • Reminders/backup data collection • Investigators/clinicians • Address alerts • Pre-study • Develop protocol sections • Develop forms • During study • Centralized teaching • Monitoring • QA • Post-study (statistical) • Data cleaning • Statistical analysis

  14. NCI-Level Costs • Software system hosting, operations and maintenance • Obtain from CBIIT • Note: these are ongoing costs (i.e., not per-study)

  15. Group Level (Per Trial) • Administrative • Will estimate from feasibility trials, other trials, discussion with group leadership • In feasibility studies, providing % of site per-patient reimbursement – likely not required for standard use • Alliance: 54% IDC • RTOG: 27% IDC • Central coordination • 20% effort of study coordinator a central coordinating site • Statistical • Estimate from Alliance/Mayo statistical Center: • $1500-2500/trial (includes analyst and statistician)

  16. Site Level • Plan for estimating cost in feasibility trials • Based on measuring self-reported effort of CRAs and investigators/clinicians • Developed by Committee including NCI and external methodological experts • CRA questionnaire (administered at 6-months) • Learn system, teach patients, monitor, remind • CRA semi-structured interviews • Follow-up on questionnaire, what could expedite • Investigator/clinician questionnaire • Review patient reports SEE ATTACHED SURVEYS

  17. Excerpts from CRA Survey • How many hours of training did it take for you to learn how to use the PRO-CTCAE software system? (ask # and range) • On average, how many minutes does it take you to train a patient to use the PRO-CTCAE software system? • On average, how many minutes does it take you to train a patient? • At each follow up visit, how much time do you spend with patients to assist them…? • For each patient… on average how much time do you spend between visits addressing issues related to the PRO-CTCAE (helping patient with passwords, addressing automated alerts, etc)?

  18. Discussion Points • Adequacy of planned approaches • Feasibility at group level • Cost at site level • Other potential approaches • Future • Role of PRO-CTCAE data in study monitoring (DSMB) • Approach to AE data analysis and reporting • Regulatory role

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