Symptom and function profiles of men with localized prostate cancer.

BACKGROUND: Men diagnosed with localized prostate cancer seek information on how treatment options may impact their health-related quality of life (HRQOL). The authors used latent profile analysis (LPA) to group men according to their symptom burden and functional status and to identify patient characteristics associated with each HRQOL profile. METHODS: Patients completed the Patient-Reported Outcomes Measurement Information System and the Expanded Prostate Index Composite measures 3 months after treatment initiation. Anxiety, depression, fatigue, sleep disturbance, pain, diarrhea, urinary obstruction, urinary incontinence, erectile function, and sex satisfaction were modeled jointly using LPA, and the analysis was adjusted for covariates to examine associations between patient characteristics and profiles. RESULTS: One-third of the 373 men were not non-Hispanic white (26% were black). Four LPA profiles were identified. Men who experienced the "best HRQOL" were less likely to receive treatment, to be older, and to smoke. Men in the second best profile experienced symptoms similar to men in the best HRQOL group but reported poor sexual and urinary function, because they were more likely to receive therapy. The third profile included men with increased symptom burden and poor functioning who were likely to undergo prostatectomy and to have increased comorbidity. The "worst HRQOL" group experienced the worst symptoms and the poorest functioning, and these men were more likely to be younger, to have more comorbidities, and to smoke. CONCLUSIONS: LPA revealed that men who receive the same treatment can experience very different HRQOL impact. Understanding the factors most associated with poorer HRQOL allows clinicians to focus their care on individuals most in need of symptom management and support. Cancer 2018;124:2832-2840. © 2018 American Cancer Society.

Psychometric Evaluation of PROMIS Sexual Function and Satisfaction Measures in a Longitudinal Population-Based Cohort of Men With Localized Prostate Cancer.

BACKGROUND: There are multiple treatment options for men with localized prostate cancer that provide similar curative efficacy but differ in their impact on sexual functioning. AIM: To evaluate the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures, including items from versions 1 and 2 of the short forms. METHODS: A population-based cohort of men across North Carolina completed surveys via phone interviews at baseline (prior to treatment) and at 3, 12, and 24 months after cancer treatment initiation. Surveys included the PROMIS SexFS domains of interest in sexual activity, erectile function, orgasm, and satisfaction and the Prostate Cancer Symptom Indices. Analyses included descriptive statistics, assessment of structural validity using confirmatory factor analysis and item response theory, tests for differential item functioning, assessment of convergent validity using correlations, and evaluation of responsiveness of the PROMIS SexFS measures over time. We hypothesized that men undergoing surgery (prostatectomy) would report the poorest sexual function at the 3-month survey. RESULTS: Sample size varied by assessment point and ranged from 332‒939 men, consisting of 30% non-white men, and 30% of the sample had a high school degree or less. The items within the PROMIS orgasm domain did not form a unidimensional scale. PROMIS measures of interest in sexual activity, erectile function, and satisfaction were unidimensional and highly correlated with related Prostate Cancer Symptom Indices measures (eg, erectile function, r = 0.84‒0.95). Erectile function in the surgery group declined more at 3 months compared to the no-surgery group (2 points); this difference narrowed at 12 and 24 months after surgery, as the surgery group recovered over time. Results were similar for PROMIS Interest in Sexual Activity and PROMIS Satisfaction scales. CLINICAL IMPLICATIONS: The PROMIS SexFS measures may be used to identify effective interventions to treat sexual dysfunction and monitor sexual functioning in men with prostate cancer over time. STRENGTH & LIMITATIONS: This study was limited to men living in North Carolina who could self-report their health-related quality of life in English. However, this study was able to include more men from vulnerable populations by allowing them to self-report over the phone. CONCLUSION: This study provided strong support for use of the PROMIS SexFS (version 2) measures in men with localized prostate cancer to assess sexual interest, erectile function, and satisfaction over time. Reeve BB, Wang M, Weinfurt K, et al. Psychometric Evaluation of PROMIS Sexual Function and Satisfaction Measures in a Longitudinal Population-Based Cohort of Men With Localized Prostate Cancer. J Sex Med 2018;15:1792-1810.

Evaluating measurement invariance across assessment modes of phone interview and computer self-administered survey for the PROMIS measures in a population-based cohort of localized prostate cancer survivors.

PURPOSE: To evaluate measurement invariance (phone interview vs computer self-administered survey) of 15 PROMIS measures responded by a population-based cohort of localized prostate cancer survivors. METHODS: Participants were part of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study. Out of the 952 men who took the phone interview at 24 months post-treatment, 401 of them also completed the same survey online using a home computer. Unidimensionality of the PROMIS measures was examined using single-factor confirmatory factor analysis (CFA) models. Measurement invariance testing was conducted using longitudinal CFA via a model comparison approach. For strongly or partially strongly invariant measures, changes in the latent factors and factor autocorrelations were also estimated and tested. RESULTS: Six measures (sleep disturbance, sleep-related impairment, diarrhea, illness impact-negative, illness impact-positive, and global satisfaction with sex life) had locally dependent items, and therefore model modifications had to be made on these domains prior to measurement invariance testing. Overall, seven measures achieved strong invariance (all items had equal loadings and thresholds), and four measures achieved partial strong invariance (each measure had one item with unequal loadings and thresholds). Three measures (pain interference, interest in sexual activity, and global satisfaction with sex life) failed to establish configural invariance due to between-mode differences in factor patterns. CONCLUSIONS: This study supports the use of phone-based live interviewers in lieu of PC-based assessment (when needed) for many of the PROMIS measures.

Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer.

Importance: Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects. Objective: To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. Design, Setting, and Participants: Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015. Exposures: Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. Main Outcomes and Measures: Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. Results: Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains. Conclusions and Relevance: In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.

Reliability and validity of PROMIS measures administered by telephone interview in a longitudinal localized prostate cancer study.

PURPOSE: To evaluate the reliability and validity of six PROMIS measures (anxiety, depression, fatigue, pain interference, physical function, and sleep disturbance) telephone-administered to a diverse, population-based cohort of localized prostate cancer patients. METHODS: Newly diagnosed men were enrolled in the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study. PROMIS measures were telephone-administered pre-treatment (baseline), and at 3-months and 12-months post-treatment initiation (N = 778). Reliability was evaluated using Cronbach's alpha. Dimensionality was examined with bifactor models and explained common variance (ECV). Ordinal logistic regression models were used to detect potential differential item functioning (DIF) for key demographic groups. Convergent and discriminant validity were assessed by correlations with the legacy instruments Memorial Anxiety Scale for Prostate Cancer and SF-12v2. Known-groups validity was examined by age, race/ethnicity, comorbidity, and treatment. RESULTS: Each PROMIS measure had high Cronbach's alpha values (0.86-0.96) and was sufficiently unidimensional. Floor effects were observed for anxiety, depression, and pain interference measures; ceiling effects were observed for physical function. No DIF was detected. Convergent validity was established with moderate to strong correlations between PROMIS and legacy measures (0.41-0.77) of similar constructs. Discriminant validity was demonstrated with weak correlations between measures of dissimilar domains (-0.20--0.31). PROMIS measures detected differences across age, race/ethnicity, and comorbidity groups; no differences were found by treatment. CONCLUSIONS: This study provides support for the reliability and construct validity of six PROMIS measures in prostate cancer, as well as the utility of telephone administration for assessing HRQoL in low literacy and hard-to-reach populations.

Impact of comorbidity on health-related quality of life after prostate cancer treatment: combined analysis of two prospective cohort studies.

OBJECTIVE: To improve and individualise estimates of treatment outcomes for men diagnosed with prostate cancer, we examined the impact of baseline comorbidity on health-related quality of life (HRQL) outcomes in an analysis of two pooled, prospective cohort studies. PATIENTS AND METHODS: We studied 697 patients from three academic hospitals who received radical prostatectomy (RP), external beam radiation therapy (EBRT), or brachytherapy (BT). Measures of patient-reported bowel, urinary, and sexual symptoms along with physical and mental health were prospectively collected before treatment and 3, 12, 24, and 36 months after treatment. We assessed baseline comorbidity by the validated Index of Co-Existent Disease (ICED), abstracted from medical records. Regression mixed-models were built for each treatment group and HRQL outcome controlling for baseline age, education, marital status, risk group and patient-reported general health. RESULTS: About 71% of patients had one or more comorbid conditions at baseline. After adjusting for covariates, we found baseline comorbidity was independently associated with poorer sexual function after BT (P = 0.04) and RP (P = 0.03) but not EBRT (P = 0.35). Physical health was significantly worse for men receiving BT with more comorbidities (P = 0.02). Baseline comorbid conditions were not associated with urinary incontinence or bowel functioning. CONCLUSIONS: Comorbidity at baseline is significantly associated with poorer sexual function after prostate BT or RP. This information may help patients and their physicians anticipate outcomes after surgical and radiation treatments.

Telehealth use and perceptions among prostate cancer survivors.

BACKGROUND: Reasons underlying disparities in telehealth use among cancer survivors are unknown. METHODS: We surveyed a sociodemographically diverse population-based cohort of 487 prostate cancer survivors regarding their use and perceptions of telehealth during the COVID-19 pandemic. RESULTS: Overall, only 28.5% of survivors had used telehealth at the time of survey and just 10% felt care through telehealth is comparable to that of an in-person visit. Still, over 55% felt telehealth is a good option for initial consultations or basic care and 15% felt more likely to use telehealth since the pandemic. After adjusting for other socioeconomic factors, survivors with lower education (≤high school vs. any college) had marginally lower use of telehealth (risk ratio [RR], 0.65 [95% CI, 0.42-1.01]) and lower probability of feeling more likely to use telehealth since the pandemic (RR, 0.39 [95% CI, 0.20-0.77]). CONCLUSIONS: Differences in survivor perceptions of telehealth by education level highlight new insights underlying disparities in telehealth use and potential targets for interventions.

Cardiovascular disease prevention and management of pre-existent cardiovascular disease in a cohort of prostate cancer survivors.

PURPOSE: Cardiovascular disease (CVD) is a common cause of mortality among men with prostate cancer. However, receipt of preventive care and management of pre-existent CVD has not been well studied in prostate cancer survivors. METHODS: This study examined a prospective cohort of men newly diagnosed with localized prostate cancer between 2011 and 2013 throughout North Carolina linked to Medicare and private insurance claims and clinical data from the Veterans Affairs (VA). In patients without pre-existent CVD, the primary outcome was a composite measure of annual preventive care (blood glucose screening, cholesterol level testing, and ≥ 1 primary care provider visit). In patients with pre-existent CVD, the primary outcome was annual cardiologist visit; blood glucose, cholesterol level testing, and primary care visits were also assessed. RESULTS: Our sample comprised 492 patients successfully linked to insurance claims and/or VA data, among whom 103 (20.9%) had pre-existent CVD. Receipt of preventive care declined from 52.7% (95% confidence interval [CI], 47.7 to 57.6%) during the first year after prostate cancer diagnosis to 40.8% (95% CI: 33.7 to 48.4%) during the third year. Among patients with pre-existent CVD, only 23.4% (95% CI: 13.6 to 37.2%) visited a cardiologist in all 3 years. Black men were more likely than White men to visit a cardiologist the first year (risk ratio [RR] = 1.72, 95% CI: 1.10 to 2.71). CONCLUSION: In a population-based cohort of prostate cancer survivors, receipt of CVD preventive care declined over time, and frequency of cardiologist-led management of pre-existent CVD was low. IMPLICATIONS FOR CANCER SURVIVORS: There is a need to improve clinical strategies for reducing cardiovascular risk and managing pre-existent CVD in prostate cancer survivors.

Patient Decision-Making Factors in Aggressive Treatment of Low-Risk Prostate Cancer.

BACKGROUND: Active surveillance (AS) is underutilized for low-risk prostate cancer. This study examines decision-making factors associated with AS vs aggressive treatment in a population-based cohort of low-risk patients. METHODS: Newly diagnosed patients (n = 599) were enrolled through the North Carolina Central Cancer Registry from 2011 to 2013 and surveyed regarding 5 factors that may impact treatment decision making: perceived cancer aggressiveness, aggressiveness of treatment intent, most important goal (eg, cure, quality of life), primary information source, and primary decision maker. We examined the association between treatment decision-making factors with patient choice for AS vs aggressive treatment using multivariable logistic regression analysis. RESULTS: This is a sociodemographically diverse cohort reflective of the population-based design, with 37.6% overall (47.6% among very low-risk patients) choosing AS. Aggressive treatment intent (odds ratio [OR] = 7.09, 95% confidence interval [CI] = 4.57 to 11.01), perceived cancer aggressiveness (OR = 4.93, 95% CI = 2.71 to 8.97), most important goal (cure vs other, OR = 1.72, 95% CI = 1.12 to 2.63), and primary information source (personal and family vs physician, OR = 1.76, 95% CI = 1.10 to 2.82) were associated with aggressive treatment. Overall, 88.4% of patients (92.2% among very low-risk) who indicated an intent to treat the cancer "not very aggressively" chose AS. CONCLUSIONS: These data from the patient's perspective shed new light on potentially modifiable factors that can help further increase AS uptake among low-risk patients. Helping more low-risk patients feel comfortable with a "not very aggressive" treatment approach may be especially important, which can be facilitated through patient education interventions to improve the understanding of the cancer diagnosis and AS having a curative intent.

Receipt of Guideline-Recommended Surveillance in a Population-Based Cohort of Prostate Cancer Patients Undergoing Active Surveillance.

PURPOSE: Prospective clinical trials have demonstrated the safety and efficacy of active surveillance for men with localized prostate cancer but also suggested that inadequate surveillance may risk missing an opportunity for cure. METHODS AND MATERIALS: We used data from a population-based cohort of active-surveillance patients to examine the rigor of surveillance monitoring in the general population. RESULTS: Among 1419 patients enrolled from 2011 to 2013 throughout the state of North Carolina in collaboration with the state cancer registry and followed prospectively, 346 pursued active surveillance. Only 13% received all guideline-recommended surveillance testing (including prostate-specific antigen, digital rectal examination, and prostate biopsy) within the first 2 years. Furthermore, adherence was <20% in all patient subgroups. CONCLUSIONS: These findings suggest that "active surveillance" as implemented in the general population may not represent the rigorous monitoring regimens used in the studies that demonstrated the safety of this management approach. More real-world studies on active surveillance are needed.

Patient-reported Quality of Life Following Stereotactic Body Radiotherapy and Conventionally Fractionated External Beam Radiotherapy Compared with Active Surveillance Among Men with Localized Prostate Cancer.

BACKGROUND: Evidence supporting the efficacy of stereotactic body radiotherapy (SBRT) for localized prostate cancer is accumulating, but comparative studies of patient-reported quality of life (QOL) following SBRT versus conventionally fractionated external beam radiotherapy (EBRT) or active surveillance (AS) are limited. OBJECTIVE: To compare QOL of patients pursuing SBRT and EBRT versus AS. DESIGN, SETTING, AND PARTICIPANTS: A population-based cohort of 680 men with newly diagnosed localized prostate cancer was prospectively enrolled from 2011 to 2013. INTERVENTION: SBRT, EBRT without androgen deprivation therapy, or AS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: QOL was prospectively assessed before treatment (baseline), and at 3, 12, and 24mo after treatment using the validated Prostate Cancer Symptom Indices, which contain four domains: sexual dysfunction, urinary obstruction/irritation, urinary incontinence, and bowel problems. Propensity weighting via logistic regression models was used to balance baseline characteristics, and the mean QOL scores of EBRT and SBRT patients were compared against AS patients as the control group. RESULTS AND LIMITATIONS: Compared with AS patients, EBRT patients had worse urinary obstructive/irritative symptoms and sexual dysfunction at 3mo, and worse bowel symptoms at 3 and 24mo. SBRT patients had similar scores as AS patients in all domains and across all time points; however, due to small sample size, worse sexual function and urinary incontinence in SBRT patients cannot be ruled out. Further research is needed to assess long-term outcomes. CONCLUSIONS: In a nonrandomized cohort of men with localized prostate cancer, SBRT appeared to result in favorable QOL results through 2yr of follow-up, but worse sexual function and urinary incontinence compared with AS cannot be ruled out completely. Larger studies with longer follow-up are needed to confirm these findings. PATIENT SUMMARY: Stereotactic body radiotherapy (SBRT) and active surveillance appear to have similar quality of life outcomes through 2yr, although worse sexual function and urinary incontinence from SBRT cannot be ruled out completely.

Prostate Cancer Patient Characteristics Associated With a Strong Preference to Preserve Sexual Function and Receipt of Active Surveillance.

Background: Men with early-stage prostate cancer have multiple options that have similar oncologic efficacy but vary in terms of their impact on quality of life. In low-risk cancer, active surveillance is the option that best preserves patients' sexual function, but it is unknown if patient preference affects treatment selection. Our objectives were to identify patient characteristics associated with a strong preference to preserve sexual function and to determine whether patient preference and baseline sexual function level are associated with receipt of active surveillance in low-risk cancer. Methods: In this population-based cohort of men with localized prostate cancer, baseline patient-reported sexual function was assessed using a validated instrument. Patients were also asked whether preservation of sexual function was very, somewhat, or not important. Prostate cancer disease characteristics and treatments received were abstracted from medical records. A modified Poisson regression model with robust standard errors was used to compute adjusted risk ratio (aRR) estimates. All statistical tests were two-sided. Results: Among 1194 men, 52.6% indicated a strong preference for preserving sexual function. Older men were less likely to have a strong preference (aRR = 0.98 per year, 95% confidence interval [CI] = 0.97 to 0.99), while men with normal sexual function were more likely (vs poor function, aRR = 1.59, 95% CI = 1.39 to 1.82). Among 568 men with low-risk cancer, there was no clear association between baseline sexual function or strong preference to preserve function with receipt of active surveillance. However, strong preference may differnetially impact those with intermediate baseline function vs poor function (Pinteraction = .02). Conclusions: Treatment choice may not always align with patients' preferences. These findings demonstrate opportunities to improve delivery of patient-centered care in early prostate cancer.

Comparison of Patient Report and Medical Records of Comorbidities: Results From a Population-Based Cohort of Patients With Prostate Cancer.

IMPORTANCE: The comorbid conditions of patients with cancer affect treatment decisions, which in turn affect survival and health-related quality-of-life outcomes. Comparative effectiveness research studies must account for these conditions via medical record abstraction or patient report. OBJECTIVE: To examine the agreement between medical records and patient reports in assessing comorbidities. DESIGN, SETTING, AND PARTICIPANTS: Patient-reported information and medical records were prospectively collected as part of the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study, a population-based cohort of 881 patients with newly diagnosed localized prostate cancer enrolled in the North Carolina Central Cancer Registry from January 1, 2011, through June 30, 2013. The presence or absence of 20 medical conditions was compared based on patient report vs abstraction of medical records. MAIN OUTCOMES AND MEASURES: Agreement between patient reports and medical records for each condition was assessed using the κ statistic. Subgroup analyses examined differences in κ statistics based on age, race, marital status, educational level, and income. Logistic regression models for each condition examined factors associated with higher agreement. RESULTS: A total of 881 patients participated in the study (median age, 65 years; age range, 41-80 years; 633 white [71.9%]). In 16 of 20 conditions, there was agreement between patient reports and medical records for more than 90% of patients; agreement was lowest for hyperlipidemia (68%; κ = 0.36) and arthritis (66%; κ = 0.14). On multivariable analysis, older age (≥70 years old) was significantly associated with lower agreement for myocardial infarction (odds ratio [OR], 0.31; 95% CI, 0.12-0.80), cerebrovascular disease (OR, 0.10; 95% CI, 0.01-0.78), coronary artery disease (OR, 0.37; 95% CI, 0.20-0.67), arrhythmia (OR, 0.44; 95% CI, 0.25-0.79), and kidney disease (OR, 0.18; 95% CI, 0.06-0.52). Race and educational level were not significantly associated with κ in 18 of 19 modeled conditions. CONCLUSIONS AND RELEVANCE: Overall, patient reporting provides information similar to medical record abstraction without significant differences by patient race or educational level. Use of patient reports, which are less costly than medical record audits, is a reasonable approach for observational comparative effectiveness research.

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.