Malignant Pleural Mesothelioma Patients' Willingness To Participate In A Randomized Controlled Trial Of Radical Pleurectomy With Or Without Intraoperative Photodynamic Therapy

Radical pleurectomy (RP) is a lung-sparing alternative to extrapleural pneumonectomy (EPP) for patients with malignant pleural mesothelioma (MPM). Adjuvant radiation therapy after RP is associated with a greater complication rate than after EPP. Intraoperative photodynamic therapy (PDT) has been delivered as an alternate to radiation therapy after RP with excellent reported survival. It is unclear if these outcomes are due to RP, PDT, or both. We therefore investigated patients’ willingness to participate (WTP) in a randomized controlled trial (RCT) of RP alone versus RP plus PDT. All consecutive patients with histologically confirmed MPM seen in consultation from March 2012-December 2012 and eligible for RP and PDT were prospectively enrolled in this IRB-approved study. Immediately after radiation oncology and thoracic surgery consultations, patients participated in structured interviews in which they reviewed a written description of a hypothetical RCT comparing RP alone to RP plus PDT, were asked open-ended and focused questions regarding their motivations for and concerns about RCT enrollment, and completed a written questionnaire. WTP was evaluated using a 6-point Likert scale (1 = definitely not, 6 = definitely). Interview transcripts were analyzed using qualitative research methodology, including thematic data analysis and constant comparison techniques. Twenty-two patients were enrolled, all of whom were white. Participants had a median age of 67 years and were predominantly male (73%) and diagnosed with MPM within 3 months of interview (77%). Many patients had knowledge of RP (52%) or PDT (48%) prior to consultation. We identified 15 factors that impacted patients’ WTP that largely focused on five major themes: (1) randomization, (2) hope for cure, (3) desire to compare treatments, (4) altruism, and (5) physician opinion (Table). Overall, 50% stated they would “definitely” or “probably” participate, whereas 32% may enroll, and 18% would “probably not” or “definitely not” participate. Following consultation, 59% elected to undergo RP plus PDT. A considerable percentage of patients express a willingness to participate in a RCT comparing RP alone versus RP plus PDT for MPM. Patients’ motivations for and concerns about RCT enrollment elicited in this study are being used to optimize trial design and accrual strategies for a planned phase II/III RCT.Poster Viewing Abstract 2743; TableMotivations (m) and concerns (c) reported by patients (N = 22)Trial-design factorsnTherapy-related factorsnHumanistic/Ethical factorsnRandomization (c)12Hope for a cure (m)9Altruism towards other patients (m)8Deference to physician opinion (m)7Desire to compare treatments (m)8Deference to family opinion (m)4Concerns with experimentation (c)2PDT side effects (c)6Altruism towards science/physician/ hospital (m)1Financial incentives (m)1Potential benefit of PDT (m)2Reputation of the hospital (m)1Prior knowledge of PDT (m)1Close follow-up (m)1Availability of alternative treatments (c)1 Open table in a new tab