Nutrition and Food Security Among Veterans: Operationalizing Nutritional Functioning.

OBJECTIVE: To assess injured military veterans' experiences, beliefs, and daily physical and psychosocial functioning in relation to food and nutrition. DESIGN: We used a convergent mixed-methods study design and the International Classification of Functioning, Disability, and Health to operationalize the core constructs and influencing factors related to physical and psychosocial functioning, food, and nutrition. SETTING: Three Veterans Affairs polytrauma rehabilitation centers. PARTICIPANTS: Veterans who served in the United States military on or after September 11, 2001, and whose medical diagnoses met the criteria for polytrauma; at least 1 mild traumatic brain injury and at least 1 associated comorbidity (eg, posttraumatic stress disorder, chronic musculoskeletal pain, vestibular disturbances), for a total N of 43. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Themes from survey responses and semistructured interview data were pooled into core constructs and influencing factors. RESULTS: Thirty-seven veterans completed all surveys and participated in recorded interviews. Based on qualitative and quantitative data, veterans' relation to food and nutrition (ie, nutritional functioning) was found to be characterized by 5 core constructs, including food background, nutrition knowledge, meal aptitude, resource navigation, and navigation to/of food spaces. Nutritional functioning was found to be shaped by 5 influencing factors, including injuries and health conditions, ideological and cultural exposures, relations, current beliefs, and current behaviors. CONCLUSIONS: Nutritional functioning (food background, nutrition knowledge, meal aptitude, resource navigation, navigation to/of food spaces) among injured veterans is complex and shaped by multiple physical, psychosocial, economic, and cultural factors.

Enhancing Veteran Community Reintegration Research (ENCORE): Protocol for a Mixed Methods and Stakeholder Engagement Project.

BACKGROUND: Veteran community reintegration (CR) has been defined as participation in community life, including employment or other productive activities, independent living, and social relationships. Veteran CR is a Veterans Health Administration priority, as a substantial proportion of veterans report difficulties with veteran CR following discharge from military service. OBJECTIVE: Enhancing Veteran Community Reintegration Research (ENCORE) is a project funded by Veterans Health Administration's Health Service Research and Development Service. The goal of ENCORE is to maximize veteran and family reintegration by promoting innovative research and knowledge translation (KT) that informs and improves equitable Department of Veterans Affairs (VA) policies, programs, and services. Overall, 2 strategic objectives guide ENCORE activities: mobilize veteran CR research and promote innovation, relevance, and acceleration of veteran CR research and KT. METHODS: ENCORE uses a mixed methods and stakeholder-engaged approach to achieve objectives and to ensure that the KT products generated are inclusive, innovative, and meaningful to stakeholders. Project activities will occur over 5 years (2019-2024) in 5 phases: plan, engage, mobilize, promote, and evaluate. All activities will be conducted remotely owing to the ongoing COVID-19 pandemic. Methods used will include reviewing research funding and literature examining the gaps in veteran CR research, conducting expert informant interviews with VA program office representatives, and assembling and working with a Multistakeholder Partnership (MSP). MSP meetings will use external facilitation services, group facilitation techniques adapted for virtual settings, and a 6-step group facilitation process to ensure successful execution of meetings and accomplishment of goals. RESULTS: As of December 2022, data collection for ENCORE is ongoing, with the team completing interviews with 20 stakeholders from 16 VA program offices providing veteran CR-related services. ENCORE developed and assembled the MSP, reviewed the VA funding portfolio and veteran CR research literature, and conducted a scientific gap analysis. The MSP developed a veteran CR research agenda in 2021 and continues to work with the ENCORE team to prepare materials for dissemination. CONCLUSIONS: The goal of this program is to improve the impact of veteran CR research on policies and programs. Using a stakeholder-engaged process, insights from key stakeholder groups are being incorporated to set a research agenda that is more likely to result in a relevant and responsive veteran CR research program. Future products will include the development of an effective and relevant dissemination plan and the generation of innovative and relevant dissemination products designed for rapid KT. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42029.

Multisite Agricultural Veterans Affairs Farming and Recovery Mental Health Services (VA FARMS) Pilot Program: Protocol for a Responsive Mixed Methods Evaluation Study.

BACKGROUND: Veterans Affairs Farming and Recovery Mental Health Services (VA FARMS) is an innovative pilot program to provide supportive resources for veterans with interests in agricultural vocations. Implemented at 10 pilot sites, VA FARMS will provide mental health services and resources for veterans while supporting training in gardening and agriculture. As each pilot site project has unique goals, outreach strategies, and implementation efforts based on the local environment and veteran population, evaluating the pilot program provides a unique challenge for evaluators. This paper describes the protocol to evaluate VA FARMS, which was specifically designed to enable site variation by providing both site-specific and cross-site understanding of site implementation processes and outcomes. OBJECTIVE: The objectives of this paper are to (1) describe the protocol used for evaluating VA FARMS, as an innovative Department of Veterans Affairs (VA) agriculturally based, mental health, and employment pilot program serving veterans at 10 pilot sites across the Veterans Health Administration enterprise; and (2) provide guidance to other evaluators assessing innovative programs. METHODS: This evaluation uses the context, inputs, process, product (CIPP) model, which evaluates a program's content and implementation to identify strengths and areas for improvement. Data collection will use a concurrent mixed methods approach. Quantitative data collection will involve quarterly program surveys, as well as three individual veteran participant surveys administered upon the veteran's entrance and exit of the pilot program and 3 months postexit. Quantitative data will include baseline descriptive statistics and follow-up statistics on veteran health care utilization, health care status, and agriculture employment status. Qualitative data collection will include participant observation at each pilot site, and interviews with participants, staff, and community stakeholders. Qualitative data will provide insights about pilot program implementation processes, veterans' experiences, and short-term participation outcomes. RESULTS: Evaluation efforts began in December 2018 and are ongoing. Between October 2018 and September 2020, 494 veterans had enrolled in VA FARMS and 1326 veterans were reached through program activities such as demonstrations, informational presentations, and town-hall discussions. A total of 1623 community members and 655 VA employees were similarly reached by VA FARMS programming during that time. Data were collected between October 2018 and September 2020 in the form of 336 veteran surveys, 30 veteran interviews, 27 staff interviews, and 11 community partner interviews. Data analysis is expected to be completed by October 2022. CONCLUSIONS: This evaluation protocol will provide guidance to other evaluators assessing innovative programs. In its application to the VA FARMS pilot, the evaluation aims to add to existing literature on nature-based therapies and the rehabilitation outcomes of agricultural training programs for veterans. Results will provide programmatic insights on the implementation of pilot programs, along with needed improvements and modifications for the future expansion of VA FARMS and other veteran-focused agricultural programs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40496.

Food Insecurity and Food Worries During the COVID-19 Pandemic: A Point-In-Time Study of Injured United States Veterans.

US Military Veterans experience higher rates of food insecurity compared to civilians, but the impact of the COVID-19 pandemic on Veterans is unclear. We conducted a nationwide survey of injured post-9/11 Veterans' food security, Coronavirus exposure, and nutrition habits. Of 193 Veterans, 63 (32.6%) were food insecure. Food insecurity was associated with Hispanic ethnicity (p = 0.02), prior homelessness (p = 0.003), combat service (p < 0.0001), and food-related worries (p = 0.003). Food insecure Veterans were more likely to report anxiety about stigma related to COVID-19 infection (p = 0.007). Nutrition assistance initiatives should attend to emergent psychosocial factors, beyond well-established economic factors, that increase risk for food insecurity.

Perceptions of Public Messaging to Facilitate Help Seeking during Crisis among U.S. Veterans at Risk for Suicide.

OBJECTIVE: The primary objectives of this study were to (1) examine how veterans at risk for suicide understand and interpret suicide prevention messages, and (2) identify message features that support (or hinder) help seeking behaviors. METHOD: Individual virtual interviews (N = 40) were conducted from August 2018 to April 2019 with a nationwide sample of veterans who had a recent non-fatal suicide attempt. Participants were exposed to three messages in public circulation that promote help seeking during crisis and an interview guide steered open-ended conversations on the mechanisms of persuasive communication. Interview transcripts were analyzed using a constant comparison analytic strategy in Atlas.ti. RESULTS: Preferences for particular kinds of messages and features emerged during interviews based on a need for novel, emotionally intense stimuli among veterans. Specifically, messages with solemn themes and darker, more provocative imagery were believed to be particularly potent for engaging those at high risk. Although the goal of promoting help seeking was discernable, actionable steps (crisis line use) were not clearly communicated potentially preventing messages from increasing help seeking behaviors. CONCLUSION: While messaging was perceived as capable of intervening to promote help seeking, participants reported distinct communication preferences and needs during periods of high risk. Findings underscore the significance of involving those with lived experience to inform the effective design and use of help seeking messaging targeting veterans at risk for suicide.HighlightsPublic messaging (campaigns) is a portable suicide prevention interventionCareful study is needed to effectively communicate help seeking messagesFindings inform the effective use of campaigns with veterans at risk for suicide.

Veteran Perspectives of Barriers and Facilitators to Campaigns Promoting Help Seeking During Crisis.

The objective of this paper is to characterize barriers and facilitators reported by U.S. military veterans related to campaigns promoting help seeking during suicidal crisis. Individual telephone interviews (N = 40) were conducted from August 2018-April 2019 with a sample of veterans who had a recent non-fatal suicide attempt. Interview transcripts were analyzed using a constant comparison analytic strategy. Participants reported the four facilitators to message effectiveness: (a) potential reach of specific channels; (b) interruption of suicidal thoughts; (c) normalizing the suicidal experience and help seeking; and (d) modeling desired behavior change. Barriers that hindered campaigns were also identified and include (a) broad messages, (b) challenges in cognitive processing, (c) media avoidance and (d) a boomerang effect. This study underscores the significance of involving those with lived experience to identify factors that may improve or hinder message effectiveness.

Action Ethnography of Community Reintegration for Veterans and Military Service Members With Traumatic Brain Injury: Protocol for a Mixed Methods Study.

BACKGROUND: Numerous studies of community reintegration (CR) in traumatic brain injury (TBI) have been conducted in civilian populations, but research is limited in veteran and military service member populations. Little is known about how knowledge from civilian studies translates into veterans' experiences and needs. The US Department of Veterans Health Administration (VHA) recognizes the distinctive health care needs of post-9/11 veteran and military service members, particularly with TBI, including the need to bridge health and rehabilitation-related services from acute care and inpatient settings to veteran and military service members' homes and communities to facilitate CR. OBJECTIVE: The goal of this study is to better understand the experiences of veterans with complicated mild, moderate, or severe TBI; their families; and CR workers as veterans and servicemembers transition to and sustain living in communities. This paper describes the rationale, design, and methods used to reach this goal. METHODS: This five-year longitudinal mixed methods study uses both a community-engaged research (CEnR) approach and an ethnographic approach. The sample includes 30 veterans and service members with TBI, 13 family caregivers, 11 CR specialists, 16 key stakeholders, and 82 community events. Interviews and observations are coded and analyzed using hierarchical coding schemes and thematic analysis. Analyses include data from surveys, interviews, and participant observations. Content analysis is used to highlight the complex social context of reintegration and to triangulate quantitative data. Egocentric (personal) social network analysis is used to examine the support system a veteran or service member has in place to facilitate reintegration. RESULTS: Study enrollment and data collection are completed. Data analyses are underway. CONCLUSIONS: The results of this study may provide a heightened understanding of environmental factors affecting CR in complicated mild, moderate, or severe TBI. Veteran, servicemember and family voices and insights provide VHA clinicians and policy makers with an ecological view of CR that is grounded in the life experiences of veterans, military service members, and families. The results of this study provide a roadmap for designing and testing interventions to maximize CR in a variety of domains. The longitudinal ethnographic approach allows for capturing detailed experiences within the naturalistic context. CEnR allows collaborative assessment of the social context of reintegration with community members. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14170.

Rooted in the Community: Assessing the Reintegration Effects of Agriculture on Rural Veterans.

OBJECTIVE: To assess the effect of a veteran-oriented community agricultural initiative on transitioning rural veterans. DESIGN: Convergent mixed-method program evaluation. SETTING: Veteran-oriented farm-to-market community agricultural initiative. PARTICIPANTS: Veterans (N=43) who were members of the community agricultural initiative. MAIN OUTCOME MEASURES: Health, well-being, and reintegration were assessed by self-reported data from interviews, a demographic survey, a validated health quality of life measure (Veterans RAND-12 [VR-12]), a validated reintegration measure (Military to Civilian Questionnaire), and a general satisfaction survey. RESULTS: Veteran participants were primarily white (88.4%, n=38) and men (74.4%, n=32), and most had a service-connected disability rating (58.2%, n=25). Qualitative and quantitative data revealed that the veterans participating in this community agricultural initiative experienced health and reintegration benefits. Results on the Military to Civilian Questionnaire, VR-12, and satisfaction survey suggest that participating in this community agricultural initiative contributed to improved mental, physical, and emotional health and vocational skills, community connectedness, and interpersonal communication. Qualitative interviews supported quantitative findings and revealed that participating in the community agricultural initiative provided veterans with a sense of satisfaction, a sense of belonging, and helped decrease the stigma surrounding their veteran status. CONCLUSIONS: Veterans who participate in this community agricultural initiative reported general improvements in physical and mental health, including improvements in sleep, nutrition, and exercise, and decreases in anxiety, pain, depression, and medication and substance use, all known factors which effect veteran reintegration.

A qualitative understanding of patient falls in inpatient mental health units.

BACKGROUND: Falls are the leading cause of injury-related deaths among people age 65 and older, and fractures are the major category of serious injuries produced by falls. OBJECTIVE: Determine market segment-specific recommendations for "selling" falls prevention in acute inpatient psychiatry. DESIGN: Descriptive using focus groups. SETTING: One inpatient unit at a Veterans' hospital in the Southeastern United States and one national conference of psychiatric and mental health nurses. PATIENTS: A convenience sample of 22 registered nurses and advanced practice nurses, one physical therapist and two physicians participated in one of six focus groups. INTERVENTION: None. MEASUREMENTS: Focus groups were conducted by expert facilitators using a semistructured interview guide. Focus groups were recorded and transcribed. Content analysis was used to organize findings. RESULTS: Findings were grouped into fall risk assessment, clinical fall risk precautions, programmatic fall prevention, and "selling" fall prevention in psychiatry. Participants focused on falls prevention instead of fall injury prevention, were committed to reducing risk, and were receptive to learning how to improve safety. Participants recognized unique features of their patients and care settings that defined risk, and were highly motivated to work with other disciplines to keep patients safe. CONCLUSIONS: Selling fall injury prevention to staff in psychiatric settings is similar to selling fall injury prevention to staff in other health care settings. Appealing to the larger construct of patient safety will motivate staff in psychiatric settings to implement best practices and customize these to account for unique population needs characteristics.

Effects of a national safe patient handling program on nursing injury incidence rates.

OBJECTIVE: The objective of the study was to identify which components of a system-wide safe patient handling (SPH) program reduced musculoskeletal injury (MSI) due to patient handling among nurses. METHODS: The 3-year longitudinal study from 2008 to 2011 used a pretest-posttest design. The study was conducted in the Veterans Health Administration, and all medical centers participated. The outcome was 2011 MSI incidence rates due to patient-related handling for nurses, expressed as injuries per 10 000 full-time employees. RESULTS: Three organizational risk factors, bed days of care, facility complexity level, and baseline MSI incidence rate, were significantly associated with MSI incidence rate and explained 21% of its variation. Five SPH components, including deployment of ceiling lifts and other new technologies, peer leader effectiveness, competency in SPH equipment use, facility coordinator link with safety committee, and peer leader training, uniquely accounted for an additional 23% of the total variation. CONCLUSIONS: Findings provide evidence to support the effectiveness of a multicomponent approach to SPH programs given contextual considerations.

Perceived Benefits of Group Exercise Among Individuals With Peripheral Neuropathy.

Exercise and training programs improve strength, functional balance, and prevent falls in a variety of populations. This article presents the qualitative findings related to the perceived benefits of participants in a randomized controlled trial that compared the effectiveness of group exercise on gait and balance in persons with peripheral neuropathy (PN). Participants with moderately severe PN were randomized into groups that received 10-week classes of Functional Balance Training (FBT) or Tai Chi or education alone. Perceptions of the intervention were overwhelmingly positive regardless of the study group. Perceived benefits reported by participants in the FBT and Tai Chi groups included awareness of how to deal with the effects of neuropathy by implementing balance strategies and a heightened sense of walking to prevent falls. This study offers a guide to design future exercise studies that promote simple balance exercises that can be performed in group settings.

Processes and outcomes of the veterans health administration safe patient handling program: study protocol.

BACKGROUND: Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are consistently listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics. These MSIs are typically caused by high-risk patient caregiving activities. In 2008, a safe patient handling (SPH) program was implemented in all 153 Veterans Administration Medical Centers (VAMCs) throughout the United States to reduce patient handling injuries. OBJECTIVE: The goal of the present study is to evaluate the effects associated with the national implementation of a comprehensive SPH program. The primary objectives of the research were to determine the effectiveness of the SPH program in improving direct care nursing outcomes and to provide a context for understanding variations in program results across sites over time. Secondary objectives of the present research were to evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, to explore the potential mediating and moderating mechanisms, and to identify unintended consequences of implementing the program. METHODS: This 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals. The analyses will include data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. For this study, a 3-tiered measurement plan was used. For Tier 1, the unit of analysis was the facility, the data source was the facility coordinator or administrative data, and all 153 VAMCs participated. For Tier 2, frontline caregivers and program peer leaders at 17 facilities each completed different surveys. For Tier 3, six facilities completed qualitative site visits, which included individual interviews, focus groups, and nonparticipant observations. Multiple regression models were proposed to test the effects of SPH components on nursing outcomes related to patient handling. Content analysis and constant comparative analysis were proposed for qualitative data analysis to understand the context of implementation and to triangulate quantitative data. RESULTS: All three tiers of data for this study have been collected. We are now in the analyses and writing phase of the project, with the possibility for extraction of additional administrative data. The focus of this paper is to describe the SPH program, its evaluation study design, and its data collection procedures. This study evaluates the effects associated with the national implementation of a comprehensive SPH program that was implemented in all 153 VAMCs throughout the United States to reduce patient handling injuries. CONCLUSIONS: To our knowledge, this is the largest evaluation of an SPH program in the United States. A major strength of this observational study design is that all VAMCs implemented the program and were included in Tier 1 of the study; therefore, population sampling bias is not a concern. Although the design lacks a comparison group for testing program effects, this longitudinal field study design allows for capturing program dose-response effects within a naturalistic context. Implementation of the VA-wide SPH program afforded the opportunity for rigorous evaluation in a naturalistic context. Findings will guide VA operations for policy and decision making about resources, and will be useful for health care, in general, outside of the VA, in implementation and impact of an SPH program.

Bearing the burden: deployment stress among army national guard chaplains.

Military Chaplains are a critical component of behavioral health and spiritual support in combat operations. Support of combat operations has taken a toll on these caregivers. The purpose of this study was to explore the impact of deployment on the psychosocial and health characteristics and reintegration of Army National Guard (ARNG) chaplains. Seventy-four ARNG chaplains participated in an anonymous, online survey. Results were categorized into two mutually exclusive groups, combat deployed and non-combat deployed. Although both groups tended to present similar results, Combat deployed group chaplains were significantly more likely to be of higher rank, have served in a pastoral role in the ARNG longer, and present with higher scores for combat exposure, resilience, and alcohol use. Further, five and seven participants, respectively, the majority of whom were from the combat deployed group, endorsed "frequently" or "a great deal" to negative religious coping. These endorsements of abandonment may relate back to Reserve component specific deployment concerns.

The role of military chaplains in mental health care of the deployed service member.

This research utilized a cross-sectional design secondarily analyzing data from active duty military health care personnel who anonymously completed the "2005 Department of Defense Survey of Health Related Behaviors Among Active Duty Military Personnel." Sample for this analysis of Operation Iraqi Freedom/Operation Enduring Freedom deployed mental health seeking service members was N = 447. Religiosity/spirituality and psychological distress experienced by active duty military personnel who sought help from military mental health providers (MH), military chaplains (CHC) or both (CHC & MH) were explored and compared. Greater psychosocial distress seen in the CHC & MH group could be a reflection of a successful collaborative model for mental health care that is currently promoted by the military where chaplains are first line providers in an effort to provide services to those in greatest need and ultimately provide them with care from a trained mental health professional. Research and evaluation of chaplain training programs and collaborative models is recommended.

Results of a randomized phase I dose-finding trial of several doses of isoflavones in men with localized prostate cancer: administration prior to radical prostatectomy.

The purpose of this phase I dose-finding randomized controlled trial was to evaluate the safe and effective dose of isoflavones to be used in future clinical trials for prostate cancer prevention. Forty-five eligible men were supplemented with 40, 60, and 80 mg of purified isoflavones or no supplement from biopsy to prostatectomy. Compliance with the study agent, toxicity, and changes in plasma isoflavones, serum steroid hormones, prostate-specific antigen (PSA), and tissue Ki-67 were analyzed from baseline to completion of the study. Forty-four subjects completed the study with a duration of intervention of 30 (+/- 3) days. We observed significant increases in plasma isoflavones with treatment for all doses compared with controls without producing any toxicity. Significant increases in serum total estradiol were observed in the 40 and 60 mg isoflavone-treated arms. However, a significant increase in serum free testosterone was observed in the 60 mg isoflavone-treated arm. Changes in serum sex hormone-binding globulin, PSA, and percentage of tissue Ki-67 were not statistically significant with treatment for this sample size and duration of intervention. Our results identify a safe dose of purified isoflavones for future clinical trials and establish the need for further definitive, well-powered trials to examine the role of isoflavones in prostate carcinogenesis.

Results of a Randomized Clinical Trial of the Action of Several Doses of Lycopene in Localized Prostate Cancer: Administration Prior to Radical Prostatectomy.

PURPOSE: The purpose of this Phase II randomized-controlled trial was to evaluate the safety and effect of administering several doses of lycopene to men with clinically localized prostate cancer, on intermediate endpoint biomarkers implicated in prostate carcinogenesis. METHODS: Forty-five eligible men with clinically localized prostate cancer were supplemented with 15, 30 or 45 mg of lycopene or no supplement from biopsy to prostatectomy. Compliance to study agent, toxicity, changes in plasma lycopene, serum steroid hormones, PSA and tissue Ki-67 were analyzed from baseline to completion of intervention. RESULTS: Forty-two of forty-five five subjects completed the intervention for approximately 30 days from the time of biopsy until prostatectomy. Plasma lycopene increased from baseline to post treatment in all treatment groups with greatest increase observed in the 45 mg lycopene-supplemented arm compared to the control arm without producing any toxicity. Overall, subjects with prostate cancer had lower baseline levels of plasma lycopene similar to those observed in previous studies in men with prostate cancer. Serum free testosterone decreased with 30 mg lycopene supplementation and total estradiol increased significantly with 30 mg and 45 mg supplementation from baseline to end of treatment, with no significant increases in serum PSA or tissue Ki-67. These changes were not significant compared to the control arm for this sample size and duration of intervention. CONCLUSIONS: Although antioxidant properties of lycopene have been hypothesized to be primarily responsible for its beneficial effects, our study suggests that other mechanisms mediated by steroid hormones may also be involved.

A Phase II randomized, placebo-controlled clinical trial of purified isoflavones in modulating steroid hormones in men diagnosed with localized prostate cancer.

Our purpose was to evaluate the safety and effectiveness of purified isoflavones in producing an increase in plasma isoflavones and a corresponding change in serum sex hormone binding globulin (SHBG) and steroid hormone levels in men diagnosed with early stage prostate cancer. In this Phase II randomized, double-blinded, placebo-controlled trial, 53 prostate cancer patients with a Gleason score of 6 or below were supplemented with 80 mg purified isoflavones or placebo for 12 weeks. Changes in plasma isoflavones, serum steroid hormones, and safety markers were analyzed from baseline to 12 wk. A total of 50 subjects completed the study. Although significant increases in plasma isoflavones (P < 0.001) was observed with no clinical toxicity, the corresponding modulation of serum SHBG, total estradiol, and testosterone in the isoflavone-treated group compared to men receiving placebo was nonsignificant. Increasing plasma isoflavones failed to produce a corresponding modulation of serum steroid hormone levels in men with localized prostate cancer. The study establishes the need to explore other potential mechanisms by which prolonged and consistent purified isoflavone consumption may modulate prostate cancer risk.