Author of

• 10883

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  P1.14 - Poster Session 1 - Mesothelioma (ID 194)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Mesothelioma
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10896

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    P1.14-014 - Patients' Willingness to Participate in a Randomized Controlled Trial for Malignant Pleural Mesothelioma: A New Paradigm to Improve Accrual to Thoracic Oncology Trials (ID 3147)

    09:30 - 09:30  |  Author(s): A. Shah
    • Abstract

    Background
    Predicting if a trial will accrue is critical, especially for thoracic oncology trials that have notoriously low accruals. Our group demonstrated unusually good results treating malignant pleural mesothelioma (MPM) with radical pleurectomy (RP), intraoperative photodynamic therapy (PDT), and chemotherapy. To establish if PDT is contributing to our results, a randomized trial of RP+/-PDT is needed. To determine if such a trial is feasible, we conducted a willingness to participate (WTP) study. We quantified differences in WTP before and after physician training designed to increase WTP.

    Methods
    All consecutive MPM patients who were candidates for RP+PDT were prospectively enrolled in this IRB-approved study. Patients participated in structured interviews, reviewed a written description of a hypothetical RCT comparing RP to RP+PDT, answered open-ended and focused questions regarding their motivations for and concerns about enrollment, and completed a written questionnaire. WTP was assessed using a 6-point Likert scale (1=definitely not, 6=definitely). Interview transcripts were analyzed using thematic data analysis and constant comparison techniques. Questionnaire and transcript data were used to educate physicians and modify their presentation of the RCT to subsequent patients.

    Results
    25 participants (median age 66yrs, 72% male, 88% epithelial histology) enrolled. Some had pre-existing knowledge of RP (44%) or PDT (40%). Following the first 8 patients enrolled, we identified 15 factors impacting WTP focusing on five themes: randomization, hope for cure, desire to compare treatments, altruism, and physician opinion (Table 1). Based on these findings, physicians were trained to more thoroughly explain the WTP and proposed RTC and addressed concerns raised by these initial 8 patients when meeting with subsequent patients. Physician time explaining the WTP increased following training (median 9min vs. 3min, p<0.0001). Overall, 56% “definitely” or “probably” would, 28% “may,” and 16% would “probably not” or “definitely not” participate. More patients would be “definitely” or “probably” willing to participate after physician training (71% vs. 25%, p=0.03). Furthermore, none of the initial 8 patients were “definitely” willing, compared with 8 of the subsequent 17 (p=0.02). Following consultation, 16 underwent surgical-based therapy, with no difference before or after training (50% vs. 71%, p=0.34).

    Table 1. Motivations (m) and concerns (c) reported by patients (N=25) when deciding if they would enroll in the proposed randomized clinical trial for malignant pleural mesothelioma

    Trial Design Factors	N=	Therapy-relate Factors	N=	Humanistic/Ethical Factors	N=
    Randomization (c)	12	Hope for a cure (m)	10	Altruism towards other patients (m)	9
    Deference to physician opinion (m)	7	Desire to compare treatments (m)	8	Deference to family opinion (m)	4
    Concerns with experimentation (c)	2	PDT side effects (c)	6	Altruism towards science/physician/ hospital (m)	1
    Financial incentives (m)	1	Potential benefit of PDT (m)	3
    Reputation of the hospital (m)	1	Prior knowledge of PDT (m)	1
    Close follow-up (m)	1	Availability of alternative treatments (c)	1

    Conclusion
    This study demonstrated analyzing and addressing patient motivations and concerns about enrollment, physician training, and increasing time spent with patients can increase WTP. In this study, most patients expressed a WTP in a RCT of RP+/-PDT for MPM. Performing WTP studies prior to planned prospective thoracic oncology trials should be considered to optimize trial design and accrual strategies.