Zahrieh, David M.

151 Background: Decision aids (DAs) for prostate cancer treatment can improve knowledge and reduce decisional conflict, but the relative effect of pre-visit and within-visit DAs is not known, and effect sizes for minority populations has not been estimated. Methods: We conducted a 3-arm, patient-level-RCT in specialty urology and radiation oncology practices in Ohio, South Dakota, and Alaska, test the effect of pre-consultation and with-in consultation decision aids on patient knowledge immediately after specialty consultation compared to usual care. We used linear regression to estimate effects of each intervention arm, including the respective standard error, two-sided 95% confidence interval, and two-sided P value for testing the study’s hypotheses. Results: 103 patients were recruited and randomized to receive either the pre-visit decision aid, within-visit decision aid, or neither decision aids (usual care). In 2017 and 20018, we accrued similar numbers of men to pre-consultation aid (n = 37), during-consultation aid (n = 33) and usual care arms, respectively (n = 33). The median (range) age in years was 64 [49, 81]; 67.6% were White, 15.7% were Black or African American, 16.7% were American Indian or Alaska Native, and 1% were not reported. 47.6%, 45.6%, and 6.8% had a baseline clinical stage of T1, T2, and T3, respectively. The median [range] prostate specific antigen (PSA) was 8.0 [2.4, 53.7]. There were no clinically notable imbalances. We obtained usable data on 102 of the 103 patient-participants. The pre-visit decision aid arm showed a mean knowledge effect of 0.694 (0.636, 0.753). The within-visit decision arm showed a very similar mean knowledge effect of 0.686 (0.625, 0.748). The usual care arm showed a mean knowledge effect of 0.644 (0.582,0.705). The linear regression model showed, that, compared with usual care, neither intervention effect achieved statistical significance in the primary analysis (p = 0.24, 0.330, for pre-visit and within-visit, respectively). Conclusions: Modest knowledge gains of pre-visit and during-visit decision aids for prostate cancer treatment were not statistically significant. Clinical trial information: NCT03182998 .

e24176 Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .

Abstract INTRODUCTION Participating in a clinical trial is a personal choice and an individual experience. Several barriers to recruitment of high risk men and women in chemoprevention trials have been documented; however, to our knowledge, there are no existing reports on participant satisfaction in such trials. Therefore, our aim was to describe and evaluate participants’ perception of their experience with participating in chemoprevention trials conducted by CPN by summarizing the 5-item “Was It Worth It” (WIWI) tool for each trial and across the trials, and according to race/ethnicity, sex, age, site, and organ of primary interest. METHODS Because participants who participate in chemoprevention trials tend to be at increased cancer-risk, but otherwise healthy, the WIWI tool can help answer simple questions about participants’ assessment of whether or not participation in such a trial was worthwhile. The WIWI tool was consistently administered at the end of the intervention period in each trial conducted by CPN; since 2003, 7 trials have completed the study intervention period and are included in the results reported here. RESULTS The scientific focus of the 7 trials targeted 5 organs: breast, colorectum, esophageal, hepatobiliary, and lung. Of the 485 participants registered to these 7 trials, 419 (86.4%) were non-Hispanic white, 19 (3.9%) non-Hispanic black, 32 (6.6%) Hispanic, 14 (2.9%) other race/ethnicity, and 1 (0.2%) unknown race/ethnicity; there were 120 (24.7%) females. In total, 446 (92.0%) participants completed the WIWI questionnaire at the end of their respective intervention period. Across the trials, 93% [95% CI] [90.6%, 95.4%] of the participants indicated that participation was worthwhile and 92% [89.5%, 94.5%] reported that they would participate again. Additionally, 414 (92.8%) participants indicated that they would recommend participating in the current research study to others, while 10 (2.3%) indicated that they would not and 22 (4.9%) were uncertain. Furthermore, several participants provided actionable feedback to the question “If there was one thing that could have been done to improve your experience in this research study, what would it be?” Participant feedback on overall changes in quality of life and on their expectations with participation in the trial was positive but more nuanced, varying according to trial and participant composition. CONCLUSION In this dataset of chemoprevention trial participants enrolled through the CPN consortium, highly favorable feedback was evident with respect to the overall study experience, suggesting that the recruitment and retention methods employed are facilitating success. These data can be used to help advance the NCI accrual quality improvement program in developing/enhancing strategies to improve accrual, retention, and adherence as well as enhance participant diversity in subsequent trials. Citation Format: David Zahrieh, Ryan P. McMurray, Nathan R. Foster, Paul J. Limburg, Sumithra J. Mandrekar. Participant satisfaction with cancer chemoprevention clinical trials: The Mayo Clinic Cancer Prevention Network (CPN) experience [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 5092.

e23111 Background: Acupuncture has been shown to reduce aromatase inhibitor-induced arthralgias, as well as possibly hot flashes and fatigue, but research has been limited. The purpose of this study was to evaluate real world perceived benefit of acupuncture for commonly experienced symptoms among breast cancer survivors. Methods: Breast cancer survivors who had used acupuncture for cancer- or treatment-related symptoms were identified using an ongoing prospective Mayo Clinic Breast Disease Registry (MCBDR) cohort. In addition, Mayo Clinic electronic health records (EHR) were queried to identify additional participants. All identified patients were mailed a survey with acupuncture-related questions. Respondents were also asked to recall their severity of arthralgia, myalgia, post-surgical pain, hot flashes, nausea/vomiting, fatigue, depression, anxiety, insomnia, lymphedema, headache, and neuropathy from 1 to 5 (1 = mild, 5 = severe) before and after acupuncture treatment. Results: Acupuncture use was reported among 413 participants in MCBDR (12% of all enrollees) and 73 patients were identified in the Mayo EHR. 241 eligible women returned surveys (median age at diagnosis 50 yrs). Mean symptom severity scores decreased from before to after acupuncture by at least 1 point for all queried symptoms (Table). Conclusions: Acupuncture is frequently used by patients for a variety of breast cancer-related symptoms. Those who do pursue acupuncture usually perceive few toxicities and substantial benefits. Cost may be a barrier to treatment for some. [Table: see text]