Development of the Prostate Cancer Treatment Decision Framework: A Context-Specific Expansion of the Risk-as-Feelings Hypothesis.

BACKGROUND: Over the past 2 decades, numerous decision-making interventions have been developed to guide the prostate cancer (PrCA) treatment choices of patients and families. These interventions are often supported by economic decision frameworks, which do not account for the role of emotions in treatment decisions. In some instances, emotion-driven decisions can override an individual's cognitive evaluation of a decision, leading to unfavorable outcomes such as decision regret. OBJECTIVES: To produce a Prostate Cancer Treatment Decision Framework based on the Risk-as-Feelings Hypothesis. METHODS: The authors reviewed seminal research in emotion and decision-making in an effort to create a context-specific decision framework. RESULTS: Five variables, not germane to the Risk-as-Feelings Hypothesis, play prominent roles in PrCA decision-making including age, spirituality, family support, healthcare provider communication, and perception of treatment outcomes. While family support only affects decision outcomes by influencing emotion and cognitive evaluation of a PrCA decision, age, spirituality, and healthcare provider communication can have direct effects on an individual's perception of treatment outcomes. CONCLUSIONS: The Prostate Cancer Treatment Decision Framework combines new variables with older models to explain the PrCA treatment decision-making process and elucidate relationships affecting treatment outcomes and survivors' perceptions of these outcomes. The core premise of this model can be applied to other high-risk health decisions. IMPLICATIONS FOR PRACTICE: Healthcare providers have the greatest influence on PrCA treatment decision-making. Using a shared decision-making approach, providers should take into account a patient's personal characteristics and values, in addition to clinical presentation, to help patients with treatment decisions.

Systematic Review of Commercially Available Mobile Phone Applications for Prostate Cancer Education.

Prostate cancer is the most commonly diagnosed non-skin cancer among all men and the second most common cause of death. To ameliorate the burden of prostate cancer, there is a critical need to identify strategies for providing men with information about prostate cancer screening and the importance of informed decision making. With mobile phones becoming more ubiquitous, many individuals are adopting their phones as sources for health information. The objective of this systematic review is to identify and evaluate commercially available apps for promoting informed prostate cancer screening decisions. Two keywords "prostate cancer screening" and "prostate cancer" were entered into the search engines of Google and iOS app stores in May 2017. Evaluations were conducted on apps' (a) quality, (b) grade-level readability, (c) cultural sensitivity, and (d) usability heuristics. None of the 14 apps meeting the inclusion criteria contained the full breadth of information covered in the 2016 American Cancer Society's Prostate Cancer Prevention and Early Detection Guidelines, but over half were inclusive of topics consistent with these guidelines. Most apps' readability was higher than an eighth-grade reading level. Most apps were also not framed and had a neutral tone. Only four apps met most criteria for being culturally sensitive to African Americans. Usability among apps was variable, but some contained major usability concerns. Recommendations for improving educational apps for prostate cancer screening include: disseminating evidence-based information; using culturally sensitive language; knowing the implications of the one and framing of content; making apps interactive; and following common usability principles.

Evaluation, validation and refinement of noninvasive diagnostic biomarkers for endometriosis (ENDOmarker): A protocol to phenotype bio-specimens for discovery and validation.

OBJECTIVE: Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker study was designed by the NICHD Reproductive Medicine Network (RMN) to obtain well characterized and phenotyped bio specimens in a standardized fashion from women with and without endometriosis. DESIGN: Development of a diagnostic test. SETTING: Academic medical centers. PATIENTS: This study will enroll up to 500 participants, and follow them for up to 5 months. Included subjects are aged 18-44, scheduled to undergo gynecologic surgery (laparoscopy/laparotomy) for clinical reasons. INTERVENTIONS: Presence and stage of endometriosis (or its absence) is characterized by visual examination at the time of surgery. Subjects will undergo extensive clinical evaluation pre-operatively and at visits one and four months postoperatively. Endometrial biopsy, blood, urine and disease specific questionnaires will be collected at each visit. MAIN OUTCOME: Samples will be placed in a bio-repository to be used to validate and optimize the clinical use of genomic classifiers of the endometrium alone or in combination with serum cytokines as a non-surgical composite marker of endometriosis. CONCLUSION: This protocol can serve as a reference for objective collection of high quality bio specimens for discovery or validation of potential nonsurgical diagnosis of presence or severity of disease.

Predictors of participant retention in infertility treatment trials.

OBJECTIVE: To identify variables associated with retention (or dropout) in infertility clinical trials. Retention of subjects in randomized controlled clinical trials (RCTs) has received considerable attention, but there have been few consistent findings. DESIGN: Secondary analysis of data from RCTs. SETTING: Academic medical centers. PATIENT(S): Women with polycystic ovary syndrome (PCOS) or couples with unexplained infertility, aged 18-40 years. INTERVENTION(S): This study is not an intervention study, but the patients in the original RCTs were treated with any or combination of metformin, clomiphene citrate (CC), letrozole, and gonadotropins. MAIN OUTCOME MEASURE(S): Successful retention versus dropout during the RCTs. RESULT(S): Race, ethnicity, body mass index (BMI), insurance coverage, history of smoking, and history of alcohol use were significantly associated with retention whether they were considered in bivariate analyses or a multivariable logistic model. Specifically, white race, higher income, having graduate degrees, normal weight, better insurance coverage, nonsmokers, and those who reported current use of alcohol at the start of the trial, had higher retention rates. CONCLUSION(S): We identified several additive and persistent predictors of retention that can be used to guide the conduct of RCTs and improve the retention rate. Given the limitation of our association analysis, methodologically sound and theoretically grounded research are warranted so that high quality data can be collected to improve our understanding on the causes of dropout. CLINICAL TRIAL REGISTRATION NUMBER: NCT00068861 (PPCOS-I), NCT00719186 (PPCOS-II), and NCT01044862 (AMIGOS).

Chlamydia trachomatis immunoglobulin G3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes.

OBJECTIVE: To determine if Chlamydia trachomatis (C. trachomatis) seropositivity, as detected by the C. trachomatis elementary body (EB)-based enzyme-linked immunosorbent assay [EB ELISA] predicts pregnancy and pregnancy outcome among infertile women with documented tubal patency. DESIGN: Cohort study. SETTING: Outpatient clinics. PATIENT(S): In all, 1,250 infertile women with documented tubal patency enrolled in 1 of 2 randomized controlled trials: Pregnancy in Polycystic Ovary Syndrome II; and the Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation. INTERVENTION(S): Sera were analyzed for anti-C. trachomatis immunoglobulin G (IgG)1 and IgG3 antibodies, using a research C. trachomatis EB ELISA. The optical density (OD)405 readings of ≥ 0.35 and ≥ 0.1 were considered positive for IgG1 and IgG3, respectively. MAIN OUTCOME MEASURE(S): Primary outcomes included pregnancy, live birth, and ectopic pregnancy. Log-linear regression was used to determine the relative risk after adjusting for age, race, treatment medication, smoking status, and current alcohol use. RESULT(S): A total of 243 (19%) women were seropositive for anti-C. trachomatis IgG3. They tended to be nonwhite and smokers. Anti-C. trachomatis IgG3 seropositive women were significantly less likely to conceive (risk ratio [RR] 0.65, 95% confidence interval [CI] 0.52-0.83) or to have a live birth (RR 0.59, 95% CI 0.43-0.80); these associations were weakened after adjusting for number of hysterosalpingography-documented patent tubes (RR 0.73, 95% CI 0.56-0.97) and (RR 0.73, 95% CI 0.50-1.04), respectively. Anti-C. trachomatis IgG3 seropositive women who conceived had a ×2.7 risk (95% CI 1.40-5.34) of ectopic pregnancy. CONCLUSION(S): Even in the presence of tubal patency, anti-C. trachomatis IgG3 seropositivity is associated with a lower likelihood of pregnancy. Anti-C. trachomatis IgG3 seropositive women have as high as 3 times the risk of ectopic pregnancy. CLINICAL TRIAL REGISTRATION NUMBER: PPCOSII: NCT00719186 and AMIGOS: NCT01044862.

Recruitment strategies in two reproductive medicine network infertility trials.

BACKGROUND: Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. METHODS: We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. RESULTS: 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. CONCLUSIONS: Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.

Prostate Cancer Knowledge and Decision Making Among African-American Men and Women in the Southeastern United States.

This study used multiple methods for assessing African-American (AA) men's and their female relatives, friends, and significant others' knowledge and cancer-related decision-making practices within the context of a prostate cancer (PrCA) education program. Data were collected from 81 participants using qualitative focus groups and 49 participants also completed quantitative pre/post surveys. Findings showed that men often relied on their female "significant other" and doctors for guidance on cancer-related decisions. Women described their role in assisting with their male partners' cancer decisions. AA men's and women's knowledge scores increased between pre- and post-tests which can indicate a greater likelihood of future participation in informed cancer-related decision making. Also, using multiple methods in formative research can provide relevant information for developing effective cancer-related interventions.

African American men's and women's perceptions of clinical trials research: focusing on prostate cancer among a high-risk population in the South.

While African Americans are at a significantly higher risk for developing certain cancers, they also have low rates of participation in cancer research, particularly clinical trials. This study assessed both African American men's and African American women's (1) knowledge of and participation in cancer-related clinical research and (2) barriers to and motivations for participating in clinical research. Data were collected from a total of 81 participants. Phase I of this research consisted of qualitative focus groups (all 81 participants). Phase II included quantitative pre/post survey data from an education program (56 participants). Findings from the study revealed that African American men and women had poor knowledge about clinical trials and the informed consent process, limited experience in participating in clinical trials, and they feared and mistrusted cancer research. Participants identified incentives, assurance of safety, knowledge and awareness, and benefiting others as motivators to participate in clinical trials research.

Written and spoken narratives about health and cancer decision making: a novel application of photovoice.

Photovoice is a community-based participatory research method that researchers have used to identify and address individual and community health needs. We developed an abbreviated photovoice project to serve as a supplement to a National Cancer Institute-funded pilot study focusing on prostate cancer (PrCA) that was set in a faith-based African American community in South Carolina. We used photovoice for three reasons: (a) to enhance communication between study participants and researchers, (b) to empower African American men and women to examine their health decisions through photographs, and (c) to better understand how participants from this community make health-related decisions. The 15 individuals participating in the photovoice project were asked to photograph aspects of their community that informed their health-related decisions. Participants provided written and oral narratives to describe the images in a small sample of photographs. Four primary themes emerged in participants' photographs and narratives: (a) food choices, (b) physical activity practices, (c) community environment and access to care, and (d) influences of spirituality and nature on health. Although written and audio-recorded narratives were similar in content, the audio-recorded responses were more descriptive and emotional. Results suggest that incorporating audio-recorded narratives in community photovoice presentations may have a greater impact than written narratives on health promotion, decision making, and policy makers because of an increased level of detail and personalization. In conclusion, photovoice strengthened the parent study and empowered participants by making them more aware of factors influencing their health decisions.

It takes two to talk about prostate cancer: a qualitative assessment of African American men's and women's cancer communication practices and recommendations.

Prostate cancer (PrCA) is the most commonly diagnosed nonskin cancer among men. African American (AA) men in South Carolina have a PrCA death rate 150% higher than that of European American (EA) men. This in-depth qualitative research explored AA men's and women's current practices, barriers, and recommended strategies for PrCA communication. A purposive sample of 43 AA men and 38 AA spouses/female relatives participated in focus groups (11 male groups; 11 female groups). A 19-item discussion guide was developed. Coding and analyses were driven by the data; recurrent themes within and across groups were examined. Findings revealed AA men and women agreed on key barriers to discussing PrCA; however, they had differing perspectives on which of these were most important. Findings indicate that including AA women in PrCA research and education is needed to address barriers preventing AA men from effectively communicating about PrCA risk and screening with family and health care providers.

Developing partnerships and recruiting dyads for a prostate cancer informed decision making program: lessons learned from a community-academic-clinical team.

Prostate cancer (PrCA) is the most commonly diagnosed non-skin cancer among men. PrCA mortality in African-American (AA) men in South Carolina is ~50% higher than for AAs in the U.S as a whole. AA men also have low rates of participation in cancer research. This paper describes partnership development and recruitment efforts of a Community-Academic-Clinical research team for a PrCA education intervention with AA men and women that was designed to address the discordance between high rates of PrCA mortality and limited participation in cancer research. Guided by Vesey's framework on recruitment and retention of minority groups in research, recruitment strategies were selected and implemented following multiple brainstorming sessions with partners having established community relationships. Based on findings from these sessions culturally appropriate strategies are recommended for recruiting AA men and women for PrCA education research. Community-based research recruitment challenges and lessons learned are presented.

Recruitment challenges of a multicenter randomized controlled varicocelectomy trial.

OBJECTIVE: To review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment. DESIGN: Survey of Reproductive Medicine Network (RMN) participating sites. SETTING: Reproductive Medicine Network. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails. RESULT(S): This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner. CONCLUSION(S): Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment.