scholarly journals Pretest Genetic Education Video Versus Genetic Counseling for Men Considering Prostate Cancer Germline Testing: A Patient-Choice Study to Address Urgent Practice Needs

2021 ◽  
pp. 1377-1386
Author(s):  
Jessica Russo ◽  
Carey McDougall ◽  
Nicholas Bowler ◽  
Ayako Shimada ◽  
Laura Gross ◽  
...  

PURPOSE Germline testing (GT) for prostate cancer (PCA) is now central to treatment and hereditary cancer assessment. With rising demand for and shortage of genetic counseling (GC), tools to deliver pretest informed consent across practice settings are needed to improve access to GT and precision care. Here, we report on Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWER), a patient-choice study for pretest video-based genetic education (VBGE) versus GC to inform urgent practice needs. PATIENTS AND METHODS Men with PCA or at risk for PCA (family history of PCA) were eligible and could choose pretest VBGE or GC. Outcomes included decisional conflict for GT, change in genetics knowledge, satisfaction, and intention to share results with family and/or providers. Descriptive statistics summarized results with counts and percentages for categorical variables and mean ± standard deviation for continuous variables. Data were compared with Fisher's exact, chi-squared, or Wilcoxon two-sample tests. Mean change in genetics knowledge was compared with t tests. The significance level was set a priori at .05. RESULTS Data on the first 127 participants were analyzed. Characteristics were White (85.8%), bachelor's degree (66.9%), and PCA diagnosis (90.6%). The majority chose VBGE (71%) versus GC (29%; P < .001). No differences were observed in decisional conflict for GT or satisfaction. Cancer genetics knowledge improved in both groups without significant difference (+0.9 VBGE, +1.8 GC, P = .056). Men who chose VBGE had higher intention to share GT results (96.4% VBGE v 86.4% GC, P = .02). Both groups had high rates of GT uptake (VBGE 94.4%, GC 92%). CONCLUSION A substantial proportion of men opted for pretest VBGE, with comparable patient-reported outcomes and uptake of GT. The results support the use of pretest video to address the critical GC shortage in the precision era.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 1577-1577
Author(s):  
Veda N. Giri ◽  
Nicholas Bowler ◽  
Sarah Hegarty ◽  
Laura Gross ◽  
Colette Hyatt ◽  
...  

1577 Background: Germline testing (GT) for prostate cancer (PCA) is rapidly increasing with higher demand for genetic counseling (GC). Alternate GC strategies need to be studied to address pretest informed consent. Here we conducted a patient-choice study of pretest video-based genetic education (VBGE) or in-person GC (IPGC) and assessed men’s preference and patient-reported outcomes from the first cohort of the Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWER) study. Methods: Eligibility for EMPOWER includes any male with PCA or at-risk for PCA based on family history or African American race. Men may choose pretest IPGC or VBGE. All receive results by a genetic professional. Demographics and PCA features were collected at baseline. The following outcomes and scales were assessed: baseline anxiety (GAD-7 scale), change in cancer genetics knowledge from baseline (Giri 2019), decisional conflict for GT (O’Connor 1993), and satisfaction (DeMarco 2004). Understanding of personal GT results was assessed after disclosure (Giri 2019). Descriptive statistics summarized results with counts and percentages for categorical variables and mean and standard deviation for continuous variables. Data were compared with Fisher’s exact, Chi-squared, or Wilcoxon two-sample tests, as appropriate. Mean change in cancer genetics knowledge was compared with t-tests. Significance level was set a priori at 0.05. All analyses were performed with SAS 9.4 (Cary, NC). Results: At the time of this analysis, 94 men were enrolled. Characteristics of the cohort were: White (88.3%), bachelor’s degree (67%), PCA diagnosis (93%), mean age of consent 59 years (IPGC) and 61 years (VBGE), Gleason > = 8 (32%), and > = T3 (31%). The majority preferred VBGE (77%) vs. IPGC (23%). Men who opted for IPGC had lower educational levels ( < = high school/GED) (18% IPGC vs 7% VBGE) and reported higher baseline anxiety (45% IPGC vs. 24% VBGE). Cancer genetics knowledge improved significantly with IPGC vs. VBGE (+2.5 vs +0.8; p < 0.01). No differences were observed in decisional conflict, satisfaction, or understanding of personal GT results between IPGC vs. VBGE. Both groups had high rates of GT uptake (IPGC 91%, VBGE 93%). Pathogenic mutations were identified in 15% in IPGC group and 10.4% in VBGE group. Conclusions: A substantial proportion of men opted for VBGE, and results suggest that VBGE is comparable to IPGC for men considering PCA GT. IPGC may be more suitable for men with lower knowledge of cancer genetics and greater levels or anxiety. Further study is warranted.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4651-4651
Author(s):  
James B. Yu ◽  
Pamela R. Soulos ◽  
Laura D. Cramer ◽  
Kenneth B Roberts ◽  
Jeph Herrin ◽  
...  

4651 Background: Proton radiotherapy (PRT) is a costly treatment used for prostate cancer despite little evidence supporting its use. We examined patterns of PRT use in the Medicare program and assessed the short-term toxicity of PRT vs. intensity modulated radiation therapy (IMRT). Methods: Using national Medicare claims from 2008-2009, we identified a sample of prostate cancer patients ages 66-94 who had received PRT or IMRT. We used multivariable logistic regression to identify patient and regional factors associated with receipt of PRT. We searched claims for procedure and diagnosis codes indicative of treatment-related complications and grouped the complications into genitourinary (GU), gastrointestinal (GI), and other complications. To compare the effect of PRT and IMRT on short-term toxicity, we used a Mahalanobis distance approach to match each PRT patient to two IMRT patients, achieving balanced distribution of clinical and sociodemographic characteristics. We compared six-month and one-year outcomes between the two treatment groups using conditional logistic regression. Results: We identified 27,647 men; 421 (2%) received PRT and 27,226 (98%) received IMRT. Patients who received PRT were widely geographically distributed, with some patients traveling >500 miles for treatment. PRT patients were younger, healthier, and of higher socioeconomic status. Although PRT was associated with a significant reduction in GU complications at six-months compared with IMRT (6.1% vs. 12.0%, OR 0.60 [95% CI 0.38-0.96], p=0.03), at one-year post-treatment there was no longer any difference in cumulative complication rates (18.9% vs. 21.9%, OR 0.96 [95% CI 0.61-1.53], p=0.88). There was no significant difference in GI or other complications at six-months or one-year post-treatment. Conclusions: Although PRT remains a scarcely used treatment, some prostate cancer patients traveled great distances for treatment. While PRT was associated with a reduction in six-month GU toxicity, there were no differences in toxicity at one-year. Further study on longer-term effects and other clinical and patient-reported outcomes is needed to inform the widespread application of PRT.


2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 220-220 ◽  
Author(s):  
Derek Lee ◽  
Bradford S. Hoppe ◽  
Tamara L. Smith ◽  
Christopher G. Morris ◽  
Romaine Charles Nichols ◽  
...  

220 Background: We report on quality of life (QOL) and early toxicity following proton therapy (PT) among men with prostate cancer who underwent transurethral resection of the prostate (TURP) prior to treatment. Methods: Between 2006 and 2010, 1,540 patients were treated definitively with PT for prostate cancer at UFPTI and enrolled on a prospective IRB-approved outcomes protocol. One hundred of the men had received a TURP before PT. Baseline comorbidities, medications, expanded prostate index composite (EPIC) score, international prostate symptom score (IPSS), and CTCAE vs.3 toxicity assessment were collected prospectively. The Kaplan-Meier product limit method was used to estimate freedom from toxicity. Results: Men who had TURP prior to PT had lower EPIC scores at baseline and at all followup points for urinary function, urinary incontinence, and urinary summary (Table). The TURP group also had lower EPIC bowel bother, bowel function, and bowel summary at baseline, 6-month, and 1-year followup. EPIC urinary bother, urinary irritation/obstruction, and subscales did not show a statistically significant difference at baseline, but they did show lower scores for the TURP group at variable follow-up time points. The IPSS scores among the TURP group did not show a statistical difference from the non-TURP group, except at the 6-month follow-up time point. Toxicity assessment showed that the 2-year and 3-year cumulative incidence of grade 3 GU toxicity rate in the pretreatment TURP group were 14% and 18%, respectively. Conclusions: Pretreatment TURP was associated with both a high incidence of physician-assessed toxicity and inferior patient-reported QOL scores both before and after PT treatment. Studies investigating QOL and toxicity after specific prostate cancer therapies should stratify patients by pretreatment TURP. Longer follow-up and further evaluation of risk factors for grade 3 GU toxicity among this cohort are needed. [Table: see text]


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 72-72
Author(s):  
Hong Zhang ◽  
Edward M. Messing ◽  
Hamza Ahmed ◽  
Yuhchyau Chen

72 Background: Active surveillance is now accepted initial management for men who have localized prostate cancer with low risk of disease progression. Many criteria have been used for patient identification, including Gleason score (GS) obtained from prostate biopsy. Because of concerns of sampling error, some have recommended repeated biopsy before committing to active surveillance. However, there is limited information about the risk of missing high grade disease using the current standard biopsy approach. This study seeks to compare GS difference from biopsy and surgery to provide an estimated rate of GS upgrade. Methods: The Surveillance, Epidemiology, and End Results (SEER) program was used to identify men with American Joint Committee on Cancer stage T1-2cN0M0 prostate cancer diagnosed between January 2010 and December 2010. Patients who underwent prostatectomy were selected for further analysis. Based on prostate-specific antigen (PSA) levels and GS, cases were divided into low (PSA <=10 and GS <=6) and intermediate (10<PSA<=20 or GS=7) risk groups. The rates of GS upgrade were reported for each group. Chi-square tests were used to assess differences in categorical variables (e.g. age and race) between groups of GS upgrade and no change/downgrade. Results: A total of 10,282 men were evaluated, with 9.2% (n=942) having low-risk disease, and 90.8% (n=9340) having intermediate-risk disease. Among men with low-risk prostate cancer, 22.3% (n=210) had GS upgrade and 0.8% (n=8) had GS 8 disease. Among men with intermediate risk disease, 26.2% (n=2446) had GS upgrade and 2.3% (n=214) had GS 8 disease. There was no statistically significant difference in either age or race distribution among men who had GS upgrade versus no change or downgrade at the time of surgery. Conclusions: A substantial number of low- and intermediate-risk prostate cancer patients had GS upgrade at the time of surgery, but few had upgraded to GS 8 high risk disease. These observations suggest that repeat biopsy prior to active surveillance may not be necessary.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 2-2 ◽  
Author(s):  
David P. Dearnaley ◽  
Isabel Syndikus ◽  
Helen Mossop ◽  
Alison J. Birtle ◽  
DJ Bloomfield ◽  
...  

2 Background: We aimed to explore the dose response relationship for two 3 Gray (Gy) hypofractionated radiotherapy (hRT) schedules for localised prostate cancer (PCa). Methods: hRT schedules of 60Gy/20 fractions (f) and 57Gy/19f were compared with conventional RT (cRT) 74Gy/37f; iso-effective for alpha-beta ratios of 2.5Gy and 1.5Gy respectively. The trial was powered to demonstrate non-inferiority between each hRT schedule and cRT, with 3,213 patients (pt) needed to rule out 5% inferiority (80% power, 1-sided alpha 5%) assuming 70% event-free rate in cRT, corresponding to a critical hazard ratio (HR) of 1.21. The trial was not formally powered to directly compare the two hRT schedules. Pt with N0 T1b-T3a localised PCa were randomized (1:1:1 ratio). The primary endpoint was PCa progression (freedom from biochemical failure by Phoenix consensus guidelines or PCa recurrence). Acute toxicity was assessed up to 18 weeks post treatment and late side effects to 5 years (yr) by RTOG, LENT-SOM and patient reported outcomes (PROs). Results: 3,216 pts were randomized between 2002 and 2011; 1,065 (74Gy), 1,074 (60Gy), 1,077 (57Gy). Baseline characteristics were well balanced across groups: median age 69 yr; NCCN risk group 15% low, 73% intermediate, 12% high. With median follow up 5.2yr, 5yr progression-free rate (95% CI) was 74Gy: 88.3% (86.0%, 90.2%); 60Gy: 90.6% (88.5%, 92.3%), 57Gy: 85.9 (83.4, 88.0); HR60/74: 0.83, 90% CI (0.68, 1.03), HR57/74: 1.20, 90% CI (0.99, 1.45). Significantly more events were observed with 57Gy compared to 60Gy; HR57/60: 1.44, 90% CI (1.18, 1.75), log-rank p=0.003. No significant difference in acute RTOG bladder or bowel toxicity was observed between hRT schedules. Late toxicity profile was favorable; with grade 2+ RTOG bladder (60Gy: 16/960 (1.7%); 57Gy: 11/962 (1.1%), p=0.34) and bowel (60Gy: 28/960 (2.9%); 57Gy: 17/962 (1.8%), p=0.10) toxicity at 2yr. Analysis of LENT-SOM and PROs supported these results. Conclusions: With 5 yr follow-up treatment with a 3Gy schedule of 60Gy/20f shows improved treatment efficacy compared to 57Gy/19f and is non-inferior to 74Gy/37f with a similar low level of acute and late normal tissue damage. Clinical trial information: ISRCTN97182923.


2021 ◽  
Author(s):  
Ori Haisraely ◽  
Yaacov Richard Lawrence ◽  
Ron Lewin ◽  
Orit Kaidar-Person ◽  
Ilana Weiss ◽  
...  

Abstract Purpose: To evaluate urinary continence and sexual potency following radical prostatectomy and adjuvant radiotherapy. Materials/Methods: Expanded Prostate Cancer Index Composite (EPIC) surveys of patients with localized prostate cancer treated with surgery followed by adjuvant/salvage pelvic radiotherapy (S+RT) were analyzed. A control cohort was primary radiotherapy (RT). Results: Surveys at least 1 year after treatment were available for 130 S+RT and 374 RT patients. For S+RT vs. RT, the mean urinary incontinence score was 68 [6.25 -100] versus 86.4 [CI-95 39.5-100] (p<0.001), confirming 6.5 points of clinically significant difference. The adjusted odds ratio for superior urinary function was 2.67 (1.7-4.1, p<0.001) for primary radiotherapy. The odds ratio of having both poor urinary and sexual performance was 0.29 in RT arm (0.14-0.58, p<0.001) when adjusted to age and ADT use, group risk stratification, co morbidities and smoking status. Conclusion: In this cross sectional study, Surgery with adjuvant/salvage RT was associated with significantly worse patient reported urinary continence outcomes at 1-year post treatment, lower odds of achieving perfect urinary continence and a threefold risk of reverse ‘bifecta’ with inferior urinary continence and sexual performance. Longitudinal studies of evolving toxicity are required to validate these findings.


2021 ◽  
Author(s):  
Daniel H. Kwon ◽  
Sneha Karthikeyan ◽  
Alison Chang ◽  
Hala T. Borno ◽  
Vadim S. Koshkin ◽  
...  

PURPOSE Men with metastatic castration-resistant prostate cancer increasingly encounter complex treatment decisions. Consultation audio recordings and summaries promote patient informed decision making but are underutilized. Mobile recording software applications may increase access. Little is known regarding the feasibility of implementation in clinical encounters. METHODS We conducted a mixed-methods pilot study in men with progressive metastatic castration-resistant prostate cancer. We instructed patients to use a mobile software application to record an oncology visit. Patients could share the recording with our patient scribing program to receive a written summary. We assessed feasibility and acceptability with postvisit surveys. We measured patient-reported helpfulness of the intervention in decision making and change in Decisional Conflict Scale–informed subscale. We conducted semistructured interviews to explore implementation and analyzed transcripts using thematic analysis. RESULTS Across 20 patients, 18 (90%) recorded their visits. Thirteen of 18 (72%) listened to the recording, and 14 of 18 (78%) received a summary. Eighteen of 20 (90%) visits were telehealth. Fourteen patients (70% of all 20; 78% of 18 question respondents) found the application easy to use. Nine patients (50% of 18 recording patients; 90% of 10 question respondents) reported that the recording helped treatment decision making. Decisional conflict decreased from baseline to 1-week postvisit (47.4-28.5, P < .001). Interviews revealed benefits, facilitators, contextual factors, and technology and patient-related barriers to recordings and summaries. CONCLUSION In this single-institution academic setting, a mobile application for patients to record consultations was a feasible, acceptable, and potentially valued intervention that improved decision making in the telehealth setting. Studies in larger, diverse populations are needed.


2021 ◽  
Author(s):  
Ori Haisraely ◽  
Yaacov Richard Lawrence ◽  
Ron Lewin ◽  
Orit Kaidar-Person ◽  
Ilana Weiss ◽  
...  

Abstract Purpose: To evaluate urinary continence and sexual potency following radical prostatectomy and adjuvant radiotherapy.Materials/Methods: Expanded Prostate Cancer Index Composite (EPIC) surveys of patients with localized prostate cancer treated with surgery followed by adjuvant/salvage pelvic radiotherapy (S+RT) were analyzed. A control cohort was primary radiotherapy (RT). Reverse "bifecta" was defined as a score less than 60 in both incontinence and sexual domains. Superior urinary function was defined as a score above 90. The clinically important difference was calculated using a distribution approach.Results: Surveys at least 1 year after treatment were available for 130 S+RT and 374 RT patients. For S+RT vs. RT, the mean urinary incontinence score was 68 [6.25 -100] versus 86.4 [CI-95 39.5-100] (p<0.001), confirming 6.5 points of clinically significant difference. The adjusted odds ratio for superior urinary function was 2.67 (1.7-4.1, p<0.001) for primary radiotherapy. The odds ratio of having both poor urinary and sexual performance (reverse " bifecta") was 0.29 in RT arm (0.14-0.58, p<0.001) when adjusted for age and Androgen Deprivation Therapy (ADT) , group risk stratification, comorbidities and smoking status.Conclusion: In this cross sectional study, Surgery with adjuvant/salvage RT was associated with significantly worse patient reported urinary continence outcomes at 1-year post treatment, lower odds of achieving perfect urinary continence and a threefold risk of reverse ‘bifecta’ with inferior urinary continence and sexual performance. Longitudinal studies of evolving toxicity are required to validate these findings. Patients referred for surgery with a high probability of requiring adjuvant or salvage radiotherapy should be informed regarding the potential composite toxicity of both surgery and radiotherapy.


The Prostate ◽  
2018 ◽  
Vol 78 (12) ◽  
pp. 879-888 ◽  
Author(s):  
Veda N. Giri ◽  
Elias Obeid ◽  
Sarah E. Hegarty ◽  
Laura Gross ◽  
Lisa Bealin ◽  
...  

Author(s):  
Zhipeng Chen ◽  
Shuizhong Cen ◽  
Jionglin Wu ◽  
Rui Guo ◽  
Zhenhua Liu ◽  
...  

OBJECTIVE The aim of this study was to compare a traditional cervical cage with a zero-profile (ZP) fixation device in patients who underwent three-level anterior cervical decompression and fusion (ACDF) in terms of patient-reported outcomes (visual analog scale [VAS], Japanese Orthopaedic Association [JOA], and Neck Disability Index [NDI] scores), radiographic findings (sagittal alignment 2 years after surgery and likelihood of fusion), and complications. METHODS This study was a retrospective case series. Between January 2012 and December 2016, 58 patients with cervical spondylotic myelopathy (CSM) who required three-level ACDF procedures, as identified by spinal surgeons, were treated with three-level ACDF and an anterior cage-plate construct (ACPC) (n = 38) or a three-level stand-alone ZP device (n = 20). On the basis of patient choice, patients were divided into two groups (ACPC group and ZP group). All patients completed a minimum of 2 years of follow-up. Patient-reported outcome scores included VAS, JOA, and NDI scores. The radiographic findings included sagittal alignment and likelihood of fusion 2 years after surgery. Data related to patient-reported outcomes and sagittal alignment were collected preoperatively, postoperatively, and at the final follow-up. Intraoperative and postoperative complications were also documented and analyzed. RESULTS The clinical outcomes, including VAS, JOA, and NDI scores, showed improvement in both groups, and no significant difference was observed between the two groups. Sagittal alignment and height of the fused segments were restored in all patients. However, the authors found no differences between the ZP and ACPC groups, and the groups exhibited similar fusion rates. The authors found no differences in complications, including dysphagia, adjacent-segment degeneration, and postoperative hematoma, between the groups. CONCLUSIONS Use of ZP implants yielded satisfactory long-term clinical and radiological outcomes that were similar to those of the standard ACPC. Additionally, the rates of complications between the groups were not significantly different. Although the best surgical option for multilevel CSM remains controversial, the results of this work suggest that ACDF with the ZP device is feasible, safe, and effective, even for multilevel CSM.


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