Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials.

INTRODUCTION: Previous studies by our group and others have demonstrated the importance of sociodemographic factors in cancer-related outcomes. The identification of these factors has led to novel approaches to the care of the high-risk cancer patient, specifically in the adoption of clinical interventions that convey similar benefits as favorable sociodemographic characteristics. This study examined the importance of marital status and race as prognostic indicators in men with prostate cancer. METHODS: This report is a meta-analysis of 3,570 patients with prostate cancer treated in three prospective RTOG clinical trials. The Kaplan-Meier method was used to estimate the survival rate and the cumulative incidence method was used to analyze biochemical failure rate. Hazard ratios were calculated for all covariates using either the Cox or Fine and Gray's proportional hazards model or logistic regression model with associated 95% confidence intervals and p values. RESULTS: Hazard ratio (HR) for overall survival (OS) for single status compared to married status was 1.36 (95% CI, 1.2 to 1.53). OS HR for non-White compared to White patients was 1.05 (CI 0.92 to 1.21). In contrast, the disease-free survival (DFS) HR and biochemical failure (BF) HR were both not significantly different neither between single and married patients nor between White patients and non-White patients. Median time to death for married men was 5.68 years and for single men was 4.73 years. Median time for DFS for married men was 7.25 years and for single men was 6.56 years. Median time for BF for married men was 7.81 years and for single men was 7.05 years. CONCLUSIONS: Race was not associated with statistically significant differences in this analysis. Congruent with our previous work in other cancer sites, marital status predicted improved prostate cancer outcomes including overall survival. IMPLICATIONS FOR CANCER SURVIVORS: Prostate cancer is the most common visceral cancer in men in the USA. The stratification of prostate cancer risk is currently modeled solely on pathologic prognostic factors including PSA and Gleason Score. Independent of these pathologic prognostic factors, our paper describes the central sociodemographic factor of being single as a negative prognostic indicator. Single men are at high risk of poorer outcomes after prostate cancer treatment. Intriguingly, in our group of patients, race was not a significant prognostic factor. The findings in this paper add to the body of work that describes important sociodemographic prognostic factors that are currently underappreciated in patients with cancer. Future steps will include the validation of these findings in prospective studies, and the incorporation of clinical strategies that identify and compensate for sociodemographic factors that predict for poorer cancer outcomes.

Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215.

INTRODUCTION: Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT. AIM: The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT. METHODS: In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data. MAIN OUTCOME MEASURES: The primary end point was improved erectile function, as measured by the IIEF. RESULTS: The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤ 120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase. CONCLUSIONS: This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer.

The impact of diabetes on depression treatment outcomes.

BACKGROUND: Individuals with diabetes mellitus (DM) are two to four times more likely to be diagnosed with major depressive disorder (MDD). However, few controlled studies have examined the impact of DM on the treatment of MDD. Understanding the effect of DM on depressed patients could provide valuable clinical information toward adjusting current treatment modalities to produce a more effective treatment for depressed patients with DM. METHODS: This study was conducted using an evaluable sample of 2876 outpatient participants enrolled in the Sequenced Treatment Alternatives to Relieve Depression study. Sociodemographic and clinical characteristics and treatment characteristics with the selective serotonin reuptake inhibitor (SSRI) citalopram, as well as remission rates for MDD and time to remission, were compared between participants with DM and participants without DM. RESULTS: The odds of remission were lower in participants with DM than in those without DM prior to adjustment [odds ratio (OR)=0.68; 95% confidence interval (95% CI)=(0.49, 0.94); P=.0184]. These differences were no longer present after adjustment [OR=0.92; 95% CI=(0.64, 1.32); P=.6399]. Participants with DM reported fewer side effects than participants without DM despite similar dosing. CONCLUSIONS: Depressed patients with DM and depressed patients without DM appear to have similar rates of MDD remission, indicating that a diagnosis of DM per se has no impact on MDD remission. The findings of fewer side effects and psychiatric serious adverse events in participants with DM imply that depressed patients with DM may be excellent candidates for more aggressive SSRI dosing. This lower prevalence of side effects reported by depressed participants with DM warrants further exploration.

Do depressed patients with diabetes experience more side effects when treated with CitalopramThan their counterparts without diabetes? a STAR*D study.

OBJECTIVE: Diabetes mellitus (DM) is often comorbid with major depressive disorder, yet the impact and types of side effects experienced by patients with DM receiving antidepressant treatment have not been examined. This study examined antidepressant treatment side effects in depressed patients with and without DM to determine whether side effects differed between groups. METHOD: From July 2001 through April 2004, the Sequenced Treatment Alternatives to Relieve Depression study enrolled 2,876 outpatients with DSM-IV major depressive disorder from primary and psychiatric care settings. The current study compared participants with and without DM regarding frequency, intensity, and burden of side effects-using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)-and types of side effects experienced when treated with citalopram (12-14 weeks, 20-60 mg/d). RESULTS: There was no statistically significant difference in the maximum rating of side effects during treatment between participants with and without DM. At the last clinic visit, participants with DM reported fewer and less intense side effects and less impairment from side effects than those without DM (after adjustment for confounding effects of age, race, Hispanic ethnicity, employment status, family history of depression, anxious depression, atypical depression, age at first major depressive episode, and length of illness). However, those with DM had more side effect symptoms consistent with the diagnosis of DM (eg, blurred vision and tremors). CONCLUSIONS: Participants with DM reported experiencing side effects at lower rates than those without DM. After statistical adjustment, the groups did not differ significantly regarding types of side effects experienced.

Using focus groups to adapt ethnically appropriate, information-seeking and recruitment messages for a prostate cancer screening program for men at high risk.

PURPOSE: To adapt ethnically appropriate radio and newspaper messages in order to increase information-seeking and recruitment to the high-risk Prostate Cancer Risk Assessment Program (PRAP) using input from focus groups. METHODS: We conducted four gender- and ethnic specific-focus groups composed of up to eight participants each. Group participants ranged in age from 35-69 and were either at risk for prostate cancer or were married to someone at risk. Participants evaluated both print and radio advertisements for a PRAP media recruitment campaign, and their recommendations were used to adapt the advertisements. RESULTS: Trigger words, e.g,, "research program," were found to be a particular issue for African-American men who cited concerns about "experimentation," while the other groups cited concerns about time commitments and cost. In the print messages, familial themes garnered an overall favorable response, but Caucasian-American participants responded negatively to the use of photos of age-appropriate models. CONCLUSION: Focus groups are useful in checking health professional assumptions about health messages prior to developing awareness or recruitment advertisements or materials. There was an implied preference for "younger" models among Caucasian Americans. Radio and print messages were adapted using the focus group recommendations, i.e., focusing on familial themes, adding race-specific risk estimates and using younger-than-target group models.

A comparison of baseline sociodemographic and clinical characteristics between major depressive disorder patients with and without diabetes: a STAR*D report.

BACKGROUND: Patients with major depressive disorder (MDD) have high rates of medical comorbidities which can impair MDD treatment. Yet little is known regarding associations between the presence of a serious comorbidity and MDD treatment. The purpose of this study was to examine the baseline sociodemographic and clinical characteristics of MDD outpatients with and without diabetes mellitus to evaluate possible associations between these characteristics and the presence of comorbid diabetes. METHODS: We gathered baseline sociodemographic and clinical data for 4041 participants with non-psychotic MDD who enrolled in the STAR*D, a large-scale depression treatment protocol, and made comparisons between participants with and without diabetes. RESULTS: Participants with diabetes were more likely to be male, older, black, Hispanic, unemployed, and have less education, a lower income, higher mental functioning, lower physical functioning, atypical features, increased appetite, psychomotor slowing and leaden paralysis, and were less likely to have concurrent alcohol abuse/dependence, mood reactivity or problems with concentration. We found no significant differences between groups regarding depression severity. LIMITATIONS: The primary limitation is the lack of a clinical diagnosis of diabetes. CONCLUSIONS: We found no difference in depression severity between participants with and without diabetes. Diabetes was associated with physical symptoms of depression. Thus treatments for these participants should be directed toward these symptoms.

Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.

PURPOSE: The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. METHODS: An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. RESULTS: There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. CONCLUSION: The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

Clinical features of depression in outpatients with and without co-occurring general medical conditions in STAR*D: confirmatory analysis.

BACKGROUND: Concurrent medical comorbidity influences the accurate diagnosis and treatment of major depressive disorder (MDD). OBJECTIVE: The objective of this study was to validate previous findings from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study using a confirmation analysis in a previously unanalyzed cohort. DESIGN: Baseline cross-sectional case-control study of patients enrolling in a prospective randomized multistage treatment study of nonpsychotic MDD. SETTING: Fourteen regional U.S. centers representing 18 primary care and 23 psychiatric practices. PARTICIPANTS: 2541 outpatients with DSM-IV nonpsychotic MDD. MEASUREMENTS: Sociodemographic status, medical illness ratings, psychiatric status, quality of life, and DSM-IV depression symptom ratings. RESULTS: The prevalence of significant general medical comorbidity in this population was 50.0% (95% CI = 48.1% to 52.0%), consistent with findings reported for the first cohort. Concurrent significant medical comorbidity was associated with older age, lower income, unemployment, limited education, and longer duration of index depressive episode. The group with significant medical comorbidity reported higher rates of somatic symptoms, gastrointestinal symptoms, sympathetic arousal, and leaden paralysis. These results were generally consistent between the 2 cohorts from STAR*D. CONCLUSIONS: Major depressive disorder with concurrent general medical conditions is associated with a specific sociodemographic profile and pattern of depressive symptoms. This association has implications for diagnosis and clinical care.

Comparison of quality of life measures in a depressed population.

Measures of quality of life have been increasingly used in clinical trials. When designing a study, researchers must decide which quality of life measure to use. Some literature provides guidance through general recommendations, though lacks quantitative comparisons. In this report, 2 general quality of life measures, the 12-Item Short Form Health Survey (SF-12) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), are compared in a depressed population. STAR*D data were used to analyze the associations among the SF-12 and the Q-LES-Q. Each measure covers 6 domains, overlapping on 5 (health, self-esteem/well-being, community/productivity, social/love relationships, leisure/creativity), with the SF-12 addressing family and the Q-LES-Q addressing living situations. Strong item-by-item associations exist only between the Q-LES-Q and the SF-12 physical health items. The 2 measures overlap on the domains covered while the lack of correlation between the 2 measures may be attributed to the perspective of each question as the Q-LES-Q measures satisfaction while the SF-12 measures the patient's perception of function.

Clinical features of depressed outpatients with and without co-occurring general medical conditions in STAR*D.

BACKGROUND: A significant percentage of patients with major depressive disorder (MDD) suffer from concurrent general medical conditions (GMCs). OBJECTIVE: The objective of this preliminary report was to describe the rates of co-occurring significant GMCs and the clinical correlates and symptom features associated with the presence of GMCs. DESIGN: Baseline cross-sectional case-control study of patients enrolling in a prospective randomized multistage treatment study of MDD. SETTING: Fourteen regional U.S. centers representing 19 primary care and 22 psychiatric practices. PATIENTS: One thousand five hundred outpatients with DSM-IV nonpsychotic MDD. MEASUREMENTS: Sociodemographic status, medical illness ratings, psychiatric status, quality of life and DSM-IV depression symptom ratings. RESULTS: The prevalence of significant medical comorbidity in this population was 52.8% (95% CI 50.3-55.3%). Concurrent significant medical comorbidity was associated with older age, lower income, unemployment, limited education, longer duration of index depressive episode and absence of self-reported family history of depression. Somatic symptoms common in MDD were endorsed at a higher rate in those with GMCs. Those without a GMC had higher rates of endorsement of impaired mood reactivity, distinct mood quality and interpersonal sensitivity. CONCLUSIONS: Concurrent GMCs are common among outpatients with MDD in both primary care and specialty settings. Concurrent GMCs appear to influence the severity and symptom patterns in MDD and describe a vulnerable population with sociodemographic challenges to effective assessment and treatment.

Un lugar seguro para sus ninos: development and evaluation of a pesticide education video.

The need exists for culturally appropriate and effective educational interventions to reduce pesticide exposure in migrant and seasonal farm-worker (MSFW) communities. The development of one such intervention was part of a community-based research project which partnered the Oregon Health Sciences University and the Oregon Child Development Coalition (Migrant Head Start). The process involved identifying an optimal educational method and content, evaluating existing educational materials on pesticides, developing the selected educational tool (a video), and assessing the effectiveness of the video as an intervention. Focus groups were conducted with MSFWs to elicit their perceived need for education and desired content, method, and delivery. Four currently used educational tools were evaluated for satisfaction, preference, recall ability and knowledge change. Based on these findings, a pesticide exposure video directed at the protection of children was produced. To determine the effectiveness of the video, knowledge, satisfaction and self-reported behaviors were assessed with MSFWs. A sizeable increase in overall pesticide knowledge was measured after seeing the video (p < 0.0001). MSFWs overall were satisfied with the video and reported increased protective behaviors after seeing the video.