BackgroundRecruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.MethodsThis is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.ResultsWe recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians’ offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders’ advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge.ConclusionsWe have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies.Trial registrationClinicaltrials.gov, ID: NCT02032550. Registered on 22 November 2013.

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lems and erectile dysfunction were common in both groups, the former possibly commoner in the Swedish men and the latter in the Italians. Changes in mood and self-esteem were common in both groups. On a visual analogue scale, the Italian men reported a worse present mood than the Swedish men, but expressed a more favourable outlook on their future. Conclusion Despite differences in philosophical attitudes between Italian and Swedish men, there were no major differences in HRQL. Caution is required in interpreting these ®ndings because there were few participants and the possible inadequacy of the methods used to evaluate the complex concept of quality of life.

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Purpose/Objective(s): For NSCLC patients treated with SBRT, we investigated if proximity to the proximal bronchial tree is associated with non-cancer death. Materials/Methods: From 2006-2013 patients with a single early stage NSCLC tumors were irradiated with CBCT guided SBRT (median dose 54 Gy in 3 fractions) in 5 institutes. Patients with progressive disease, metastases, or second cancers at the time of death were scored as death from cancer; all other deceased patients were scored as non-cancer death. Treatment plans were collected, and the main and lobar bronchi were automatically delineated using atlas based segmentation. For each patient the shortest distance from the edge of the GTV to the proximal bronchial tree (PBT) was determined. Patients were stratified into 3 groups; GTV2 cm from the PBT (peripheral (A); RTOG 0236), GTV 1 cm and < 2 cm from the PBT (B), and GTV <1 cm from the PBT (C). Actuarial non-cancer survival at 1y, 2y and 5y were determined (i.e., death from cancer was censored). Association between the stratified distance of the GTV to the PBT and non-cancer death were evaluated using univariate Cox regression (at the P<0.05 level), and compared to the association with cause specific survival to test for competing mortality risk. Finally, the stratified distance was included in a multivariate Cox analysis, also including; age, gender, performance status, comorbidity index, lung-function FEV1, Mean Lung Dose, tumor diameter, and smoking history. Results: Seven hundred sixty-nine patients were identified with a median age of 75 y. Median Biologically Equivalent Dose (a/b Z 10 Gy) was 126 Gy, 180 Gy and 227 Gy for group C, B, and A, respectively, with 33, 71 and 665 patients per group. Median GTV diameter was 4.1 cm (1.1-7.0), 2.7 cm (0.9-5.7) and 2.2 cm (0.7-6.5) for groups C, B, and A, respectively. Survival rates were lower for patients in group C (Table 1) with a Hazard ratio (HR) of 2.91 (P < 0.001). Patients in group B had a lower, non-significant HR of 0.87 (P Z 0.554). The association with cause specific survival showed a significantly higher HR (2.45, P Z 0.036) for patients in group C with respect to A, but not B. In the multivariate Cox analysis, the stratified distance from the GTV to PBT was significantly associated with non-cancer death (group C: P<0.001, HR Z 3.56, group B: P Z 0.319, HR Z 0.79), as well as age (P Z 0.001, HR Z 1.03), performance status (P<0.001, HR Z 0.30) and lung-function FEV1 (P Z 0.004, HR Z 0.99). Conclusion: Patients with a tumor < 1 cm from the proximal bronchial tree had 3.56 fold higher risk of non-cancer death than patients with a peripheral tumor. Delivered dose distributions will be further studied.