Examining trajectories of anxiety in men with prostate cancer faced with complex treatment decisions.

PURPOSE: To examine changes in anxiety over time (trajectories) in men with prostate cancer faced with a decision to participate in a clinical trial and to identify demographic and study variables that predict these trajectories. METHODS: Our data come from a larger study examining the efficacy of a decision aid on decisional conflict in men with prostate cancer who were deciding whether to participate in a prostate cancer clinical trial. We used latent growth mixture models to identify 'classes' (i.e. groups) of participants with different trajectories of anxiety, as assessed by the State-Trait Anxiety Inventory state scale, and binary logistic regression to determine predictors of anxiety 'class'. RESULTS: In 128 men with prostate cancer (mean age = 63), growth mixture modelling identified two classes defined by different anxiety trajectories. One class (n = 27) started with a higher mean anxiety score and did not change over time (stable high), whereas the second class (n = 101) started with lower anxiety and significantly reduced over time (low and recovering). None of the demographic and study variables (including age, education, marital status, and decision to join the trial) was predictive of anxiety class. CONCLUSIONS: Men treated for prostate cancer who have high levels of anxiety after surgery may continue to have persistent high anxiety levels which do not reduce naturally over time. Patient or disease characteristics do not appear to predict anxiety. It is important, therefore, to monitor for anxiety in this population and refer for psychological interventions where required.

A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making.

BACKGROUND AND PURPOSE: Randomised controlled trials (RCTs) are considered the 'gold-standard' for evaluating medical treatments. However, patients and clinicians report difficulties with informed consent and recruitment. We evaluated the utility of a Decision Aid (DA) in reducing RCT-related decisional conflict, and improving RCT knowledge and recruitment. MATERIALS AND METHODS: Potential participants for a radiotherapy RCT were invited to participate in the current study. Participants were randomised to receive the RCT's participant information sheet with or without a DA. Questionnaires were administered at baseline, one and six months. The primary outcome measure was decisional conflict. Secondary outcome measures included knowledge regarding and recruitment to the RCT. RESULTS: 129 men were randomised to the DA (63) and control (66) arms. Decisional conflict was significantly lower over 6-months (p=0.048) in the DA arm. Knowledge regarding the RCT was significantly higher at 6months (p=0.033) in the DA arm. 20.6% of the DA arm (13 of 63) and 9% of the control arm (6 of 66) entered the RCT. CONCLUSIONS: This study demonstrates the utility of a DA in reducing decisional conflict and improving trial knowledge in men with cancer who are making decisions regarding RCT participation.

Contralateral prophylactic mastectomy (CPM): A systematic review of patient reported factors and psychological predictors influencing choice and satisfaction.

OBJECTIVE: Conduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have contralateral prophylactic mastectomy (CPM), and satisfaction with CPM, in women with early stage breast cancer. METHODS: Studies were identified via databases: Medline, CINAHL, Embase and PsycINFO. Data were extracted by one author and crosschecked by two additional authors for accuracy. The quality of included articles was assessed using standardised criteria by three authors. RESULTS: Of the 1346 unique citations identified, 17 were studies that met the inclusion criteria. Studies included were primarily cross-sectional and retrospective. No study utilised a theoretical framework to guide research and few studies considered psychological predictors of CPM. Fear of breast cancer was the most commonly cited reason for CPM, followed by cosmetic reasons such as desire for symmetry. Overall, women appeared satisfied with CPM, however, adverse/diminished body image, poor cosmetic result, complications, diminished sense of sexuality, emotional issues and perceived lack of education regarding alternative surveillance/CPM efficacy were cited as reasons for dissatisfaction. CONCLUSION: Current literature has begun to identify patient-reported reasons for CPM; however, the relative importance of different factors and how these factors relate to the process underlying the decision to have CPM are unknown. Of women who considered CPM, limited information is available regarding differences between those who proceed with or ultimately decline CPM.

Knowledge, attitudes and decision-making preferences of men considering participation in the TROG RAVES Prostate Cancer Trial (TROG 08.03).

BACKGROUND AND PURPOSE: The RAVES (Trans-Tasman Radiation Oncology Group 08.03) randomised controlled trial (RCT), compares adjuvant radiotherapy with early salvage radiotherapy in men with high risk histopathological features at prostatectomy. The RAVES Decision Aid study evaluates the utility of a decision aid for men considering participation in the RAVES RCT. We report the RAVES Decision Aid study participants' attitudes and knowledge regarding RCTs, decision-making preferences and decisional-conflict. MATERIALS AND METHODS: Baseline questionnaires assessed knowledge and attitudes towards RCTs and RAVES RCT. Sociodemographic and clinical predictors of knowledge were examined. Involvement in decision-making and difficulties with the decision-making process were assessed using validated tools. RESULTS: 127 men (median age=63years) were recruited through urologists (n=91) and radiation oncologists (n=36). Men preferred collaborative (35%) or semi-active (35%) decision-making roles. Most (>75%) felt the RAVES RCT was worthwhile and important with participation being wise. However, nearly half had high decisional-conflict regarding participation. Scores of objective knowledge regarding RCTs and RAVES RCT were low. CONCLUSIONS: Most men with high-risk histopathological features at prostatectomy desire active involvement in decision-making regarding further management. Despite positive attitudes towards RCTs and the RAVES RCT, there were gaps in knowledge and high decisional-conflict surrounding participation.

Women's preferences for selective estrogen reuptake modulators: an investigation using protection motivation theory.

OBJECTIVE: Selective estrogen receptor modulators (SERMs) reduce breast cancer risk by 38%. However, uptake is low and the reasons are not well understood. This study applied protection motivation theory (PMT) to determine factors associated with intention to take SERMs. METHODS: Women at increased risk of breast cancer (N=107), recruited from two familial cancer clinics in Australia, completed a questionnaire containing measures of PMT constructs. Hierarchical multiple linear regression analysis was used to analyze the data. RESULTS: Forty-five percent of women said they would be likely or very likely to take SERMs in the future. PMT components accounted for 40% of variance in intention to take SERMs. Perceived vulnerability, severity and response efficacy appeared the most influential in women's decisions to take or not take SERMs. CONCLUSION: Many women are interested in SERMs as a risk management option. Accurate risk estimation and an understanding of the benefits of SERMs are critical to women's decision making. PRACTICE IMPLICATIONS: Health professionals need to explore women's perceptions of their risk and its consequences, as well as providing clear evidence-based information about the efficacy of SERMs. Exploring the source and strength of beliefs about SERMs may allow more effective, tailored counseling.

Women's preferences for selective estrogen reuptake modulators: an investigation using the time trade-off technique.

PURPOSE: Selective Estrogen Receptor Modulators (SERMs) reduce the risk of breast cancer for women at increased risk by 38%. However, uptake is extremely low and the reasons for this are not completely understood. The aims of this study were to utilize time trade-off methods to determine the degree of risk reduction required to make taking SERMs worthwhile to women, and the factors associated with requiring greater risk reduction to take SERMs. METHODS: Women at increased risk of breast cancer (N = 107) were recruited from two familial cancer clinics in Australia. Participants completed a questionnaire either online or in pen and paper format. Hierarchical multiple linear regression analysis was used to analyze the data. RESULTS: Overall, there was considerable heterogeneity in the degree of risk reduction required to make taking SERMs worthwhile. Women with higher perceived breast cancer risk and those with stronger intentions to undergo (or who had undergone) an oophorectomy required a smaller degree of risk reduction to consider taking SERMs worthwhile. CONCLUSION: Women at increased familial risk appear motivated to consider SERMs for prevention. A tailored approach to communicating about medical prevention is essential. Health professionals could usefully highlight the absolute (rather than relative) probability of side effects and take into account an individual's perceived (rather than objective) risk of breast cancer.