Supplementary Figure 3 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

OBJECTIVE:To evaluate the role of timing (either before or during initial consultation) on the effectiveness of decision aids (DAs) to support shared-decision-making in a minority-enriched sample of patients with localized prostate cancer using a patient-level randomized controlled trial design. METHODS:We conducted a 3-arm, patient-level-randomized trial in urology and radiation oncology practices in Ohio, South Dakota, and Alaska, testing the effect of preconsultation and within-consultation DAs on patient knowledge elements deemed essential to make treatment decisions about localized prostate cancer, all measured immediately following the initial urology consultation using a 12-item Prostate Cancer Treatment Questionnaire (score range 0 [no questions correct] to 1 [all questions correct]), compared to usual care (no DAs). RESULTS:Between 2017 and 2018, 103 patients-including 16 Black/African American and 17 American Indian or Alaska Native men-were enrolled and randomly assigned to receive usual care (n = 33) or usual care and a DA before (n = 37) or during (n = 33) the consultation. After adjusting for baseline characteristics, there were no statistically significant proportional score differences in patient knowledge between the preconsultation DA arm (0.06 knowledge change, 95% CI -0.02 to 0.12, P = .1) or the within-consultation DA arm (0.04 knowledge change, 95% CI -0.03 to 0.11, P = .3) and usual care. CONCLUSION:In this trial oversampling minority men with localized prostate cancer, DAs presented at different times relative to the specialist consultation showed no improvement in patient knowledge above usual care.

Supplementary Figure 2 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 5 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

6509 Background: Accrual of underrepresented populations (URPs-racial and ethnic minorities, women, rural populations, and younger and older populations) to clinical trials has been historically low, hampering progress in cancer treatment, symptom intervention and prevention for all. In 2018, the Alliance for Clinical Trials in Oncology (Alliance), as a part of the NCI's National Clinical Trials Network (NCTN) and a Research Base for the NCI Community Oncology Research Program (NCORP) began a multi-pronged strategy to increase accrual of underrepresented minorities by race and ethnicity (URMs) to both treatment and cancer control trials conducted by the Alliance. Methods: Alliance leadership set a goal of 20% accrual for racial and ethnic minorities to all trials in 2018. The Health Disparities Committee (HDC) implemented several strategies over time including leadership promotion/expectation of goals; funding junior investigators and special projects focusing on URPs; working groups for specific populations in HDC; HDC co-chairs to selected protocols; translation services of patient facing materials; opening studies at NCORP Minority Underserved Sites; real time monitoring of accrual demographics, by Alliance and by site; protocols addressing aims for specific populations; closing protocol enrollment to majority populations; and increasing the study sample size to enroll additional minority participants to allow for analyzing intervention effects by subgroups. Results: Accrual data from 117 NCTN and NCORP trials led by Alliance was included from 2014-2022. Over time, accrual of racial and ethnic minorities increased from 13.6% to 25.3% for treatment and 13% to 21.5% for cancer control trials. This results in overall increase from 13.5 % to 23.6% of URMs for all trials, a 74.8% improvement. Conclusions: Intentional approaches to increase URMs has led to an increase in URM accruals to Alliance trials. Future strategies include implementation of the Alliance Patient Questionnaire to prospectively measure the prevalence of specific social determinants of health among patients enrolled to further expand the understanding and address the needs of unique population accrued to Alliance trials. In addition, accrual of women, rural populations, and younger and older adults (65+ years) are now being monitored over time to increase all URP accruals.

Supplementary Figure 1 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 4 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Background: Thirty-six states, including Florida, have legalized marijuana for medical and/or recreational use, yet how it is used and perceived by persons with cancer is not well understood.Objectives: The purpose of this study was to identify patterns of use, perceived benefits, and side effects of medical marijuana (MMJ) among cancer patients in Florida.Methods: For this descriptive, cross-sectional study, anyone residing within the state of Florida who was diagnosed or treated for a malignancy within the last five years and had used MMJ was eligible. An online survey containing questions about dosing, side effects, perceived benefits, and barriers to use was used. Descriptive statistics including frequencies, percentages, means, and standard deviations were used to analyze quantitative data. Responses to open-ended questions were coded and categorized.Results: Sleep (n = 112), pain (n = 96), and anxiety (n = 82) were the most common symptoms participants used MMJ to relieve and overall felt it was highly effective. MMJ was well tolerated with a minority (10.3%) reporting any adverse effects. Cost was the most frequent barrier reported by participants (42.8%). A variety of legal, bureaucratic, and system-related barriers were described.Conclusion: Participants perceived MMJ to be helpful in alleviating cancer symptoms. They held negative perceptions of the way MMJ is implemented and integrated into their oncology treatment plan. Enhanced communication and patient/provider education on MMJ are needed to inform patient decision making.

The majority of patients undergoing allo-HSCT report a poor understanding of palliative medicine. A palliative care consultation prior to allo-HSCT increases a patient's understanding of the role of palliative medicine in his/her allo-HSCT. A positive trend was observed in patients' comfort with and interest in continuing to utilize palliative medicine following initial consultation.

BACKGROUND:Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS:The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS:Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS:DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

You have accessJournal of UrologyHealth Services Research: Practice Patterns, Quality of Life and Shared Decision Making I (PD03)1 Sep 2021PD03-12 LONG-TERM DECISIONAL REGRET FOR MINORITY MEN DIAGNOSED WITH PROSTATE CANCER: RESULTS FROM A MULTI-CENTERED RANDOMIZED CLINICAL TRIAL OF DECISION AID Jon Tilburt, Joel Pacyna, George Chang, Amylou Dueck, Robert Grubb, Judith Kaur, Michael Morris, Paul Novotny, Electra Paskett, Daniel Petereit, Bruce Rapkin, Jeff Sloan, Elizabeth Storrick, David Zahrieh, Dominick Frosch, Victor Montori, Robert Volk, Ethan Basch, Jan Buckner, Kelly Parsons, Kara Babaian, Evan Kovac, and Simon Kim Jon TilburtJon Tilburt More articles by this author , Joel PacynaJoel Pacyna More articles by this author , George ChangGeorge Chang More articles by this author , Amylou DueckAmylou Dueck More articles by this author , Robert GrubbRobert Grubb More articles by this author , Judith KaurJudith Kaur More articles by this author , Michael MorrisMichael Morris More articles by this author , Paul NovotnyPaul Novotny More articles by this author , Electra PaskettElectra Paskett More articles by this author , Daniel PetereitDaniel Petereit More articles by this author , Bruce RapkinBruce Rapkin More articles by this author , Jeff SloanJeff Sloan More articles by this author , Elizabeth StorrickElizabeth Storrick More articles by this author , David ZahriehDavid Zahrieh More articles by this author , Dominick FroschDominick Frosch More articles by this author , Victor MontoriVictor Montori More articles by this author , Robert VolkRobert Volk More articles by this author , Ethan BaschEthan Basch More articles by this author , Jan BucknerJan Buckner More articles by this author , Kelly ParsonsKelly Parsons More articles by this author , Kara BabaianKara Babaian More articles by this author , Evan KovacEvan Kovac More articles by this author , and Simon KimSimon Kim More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001967.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Decision aids (DAs) for localized prostate cancer can improve prostate cancer knowledge and reduce decisional regret. However, the degree to which decision aids reduce long-term decisional regret, particularly in African-American men, remains unknown. Herein, we report our one-year results from a multi-centered clustered randomized clinical trial (CRT) of two decision aid modes—pre-visit and within-visit, and combined—assessing decisional regret for minority men diagnosed with localized prostate cancer. METHODS: From 2017 to 2019, a CRT was performed at 15 urology practices affiliated with the NCI-affiliated Alliance Community Oncology Research Program research base. Each site was randomized to one of 4 arms: pre-visit, within-visit, combined pre-+ within-visit decision aids, or usual care (no decision aid). Using a validated instrument, we assessed decisional regret at 12 months. Due to a regret score distribution skewed toward no regret, we dichotomized regret into an “any” vs. “none” binary outcome variable. Mixed-effects logistic regression, modeling the probability of no regret, was used to assess the effects of each DA after adjusting for site-clustering and race/ethnicity. RESULTS: During the trial, 158 prostate cancer patients were enrolled across the four arms: pre-visit (n=39), within-visit (n=44), pre-+ within-visit (n=25), and usual care (n=50). Overall, the mean age was 63.5 years, 54% were African-American, and 29.4%, 25.7% and 29.7% received surgery, radiation therapy, and active surveillance, respectively. 107 (67.7%) patients completed the 12-month Decision Regret Scale, and the baseline clinical characteristics were similar to the total for all patients enrolled. Within-visit, pre-visit, and pre-+ within-visit intervention arms had descriptively higher proportion of “any” decisional regret, (66.7, 56.3, and 73.3%, respectively) compared to the usual care (no DA) arm (51.2%). After adjusting for race/ethnicity, there was no significant difference in the odds of reporting no regret for the pre-visit DA (OR: 0.57 [0.198, 1.663]; p=0.31). Similarly, the within-visit group had a lower odds of no regret (OR: 0.58 [.220, 1.536]; p=0.27). The odds of reporting no regret for other race/ethnicity group compared with the odds for non-White men did not reach significance (OR: 0.42 [0.174, 1.027]; p=0.06). CONCLUSIONS: In our clinical trial with a high proportion of African-American men, decisions aids in the pre-visit, within-visit, and combined clinical setting did not improve decisional regret following a diagnosis of localized prostate cancer. Source of Funding: This study was funded by UG1CA189823 (Clinical Trial Number: NCT03103321) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e48-e48 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jon Tilburt More articles by this author Joel Pacyna More articles by this author George Chang More articles by this author Amylou Dueck More articles by this author Robert Grubb More articles by this author Judith Kaur More articles by this author Michael Morris More articles by this author Paul Novotny More articles by this author Electra Paskett More articles by this author Daniel Petereit More articles by this author Bruce Rapkin More articles by this author Jeff Sloan More articles by this author Elizabeth Storrick More articles by this author David Zahrieh More articles by this author Dominick Frosch More articles by this author Victor Montori More articles by this author Robert Volk More articles by this author Ethan Basch More articles by this author Jan Buckner More articles by this author Kelly Parsons More articles by this author Kara Babaian More articles by this author Evan Kovac More articles by this author Simon Kim More articles by this author Expand All Advertisement Loading ...

American Indians and Alaska Natives (AI/AN) are underserved populations who suffer from several health disparities, 1 of which is cancer. Malignancies, especially cancers of the breast, liver, and lung, are common causes of death in this population. Health care disparities in this population include more limited access to diagnostic radiology because of geographic and/or health system limitations. Early detection of these cancers may be enabled by improving patient and physician access to medical imaging. Awareness by the radiology community of the cancer disparities among this population is needed to support research targeted to this specific ethnic group and to support outreach efforts to provide more imaging opportunities. Providing greater access to imaging facilities will also improve patient compliance with screening recommendations, ultimately improving mortality in these populations.

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 .

Background: Although national organizations advocate that health-care providers ask patients about sexual health and sexual and gender minority status—to learn, for example, about side effects of treatment and to understand patients’ social support—these conversations often do not occur. This study explored health-care providers’ reasons for having/not having these conversations. Methods: This single-institution study recruited health-care providers from medical oncology, hematology, radiation oncology, and gynecology. Face-to-face interviews were recorded, transcribed, and analyzed qualitatively. Results: Three main themes emerged: (1) patient-centric reasons for discussing/not discussing sexual health and sexual and gender minority status (“So I think just the holistic viewpoint is important”); (2) health-care provider–centric reasons for discussing/not discussing these issues (“That’s going to take more time to talk about and to deal with…” or “I was raised orthodox, so this is not something we talk about…”; and (3) reasons that appeared to straddle both of the above themes (eg, acknowledgment of the sometimes taboo nature of these topics). Conclusion: Although many health-care providers favor talking with patients with cancer about sexual health and sexual and gender minority status, limited time, personal reluctance, and the taboo nature of these topics appear at times to hamper the initiation of these conversations.

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 .

Background: Palliative medicine physicians are challenged by lack of guidance regarding effectiveness and dosing of cannabis products in the setting of their emerging popularity. Objective: The aim of this study was to describe early patterns of tetrahydrocannabinol (THC) and cannabidiol (CBD) use in Florida following passage of the state’s first medical marijuana law. We describe here the perceived benefits, side effects, and beliefs expressed by patients in a single outpatient academic palliative medicine practice. Methods: A cross-sectional survey was performed of a sequential convenience sample of patients who presented to an outpatient academic palliative medicine clinic over a 3-month period. Results: In all, 24% (14/58) of respondents reported THC use, with half using THC on a daily basis. Patients reported improvements in pain, appetite, and nausea. In all, 71% (10/14) began using THC after the diagnosis of their chronic illness, and the most common form of usage was vaping. In all, 24% (14/58) of patients reported CBD use. Patients reported improvements in pain, and the most common form of usage was topical application. None of the patients had used CBD prior to the onset of their chronic illness. In all, 21% (3/14) of THC users and 21% (3/14) of CBD users thought that their substance was helping to cure their illness. Individual reported side effects in both groups were minimal. Conclusions: Approximately a quarter of outpatient palliative care patients use THC or CBD, often on a daily basis. Palliative care providers should be aware of the frequency, diverse usage, and beliefs behind cannabis product use in this patient population.

OBJECTIVE:This study sought to understand the patients' perspective of what contributes to an absence of discussions of sexual orientation (SO), gender identity (GI), and sexual health in cancer care. METHODS:Patients were recruited from oncology, gynecology, and a gender transition clinic to participate in semistructured interviews, which were analyzed with qualitative methods. RESULTS:A total of 25 patients were interviewed, shedding light on 2 themes. The first was that these conversations are important but infrequent. One patient explained, "…. we know people who have had sex changes…[they] would have appreciated that question." In response to whether sexual health was ever brought up, one patient responded, "No doctor ever has." Patients described unaddressed issues: "There have been times, you know, we've wondered if it was okay to make love." The second theme consisted of 4 pragmatic, patient-provided points to facilitate discussions: (1) implementation of a scale of 1 to 10 (with 10 being comfortable) to first gauge patients' comfort in talking about SO, GI, and sexual health; (2) having the health-care provider explore the topic again over-time; (3) making sure the health-care provider is comfortable, as such comfort appears to enhance the patient's comfort ("I have a doctor here, a female doctor, who just matter of fact will ask if I get erections and so on because of the medication she's giving me);" and (4) eliminating euphemisms (one patient stated, "I don't know what you mean by 'sexual health'."). CONCLUSION:Oncology health-care providers have a unique opportunity and responsibility to address SO, GI, and sexual health.

American Indians (AIs) continue to have elevated cancer incidence and mortality, and most have issues accessing cancer screening services. During 2013-2014, Mayo and its partners created Native Cancer 101 Module 10 "Prevention and Early Cancer Detection" education workshop. A community-based AI organization implemented nine of these workshops during 2014-2015 via diverse venues. Nearly all participants eligible for at least one type of cancer screening participated in a workshop and consented to follow-up within 3 to 6 months to determine if screenings had been completed or scheduled. Native Cancer 101 Module 10 workshops were conducted with 150 community members of whom 6 had recently completed cancer screening (n = 144). The workshops had a 25.20% increase in knowledge, and 97.1% of subjects responded that they would recommend the workshop to their friends and family. Most (136 of 144) submitted a consent form to be contacted 3 to 6 months following the workshop. Patient navigators reached 86 (63.2%) of the consented participants in the follow-up calls after the workshop, and 63 (46.3%) self-reported that they had completed at least one cancer screening test for which they were eligible. The single implementation of the workshop influenced community participants' completion of cancer screening.

End of life is difficult for all patients but sexual and gender minorities (SGM) are prone to isolation and loneliness, especially if their SGM status is unknown or unaccepted. In oncology clinics, where goals of care discussions about end of life are integral and frequent, querying patients about their SGM status and sexual health is of particular importance. The American Society of Clinical Oncology recently released a position statement that called for greater focus on SGM populations with the goal of reducing and eventually eliminating disparities in cancer care within this group. An important first step in addressing such disparities is learning how best to train cancer health-care providers to ask patients about their SGM status and about sexual health in general. This article summarizes the mandate for understanding cancer issues in SGM populations and the dearth of cancer-related data within this group. This article also describes an ongoing 3-part study intended to build a mini curriculum with the goal of helping cancer health-care providers to ask patients with cancer about SGM status and to ask all patients with cancer about sexual health issues. The results of this ongoing study could potentially improve end-of-life care for subgroups of patients.