Understanding the potential of digital therapies in implementing the standard of care for depression in Europe.

Depressive disorders represent the largest proportion of mental illnesses, and by 2030, they are expected to be the first cause of disability-adjusted life years [1]. The COVID-19 pandemic exacerbated prevalence and burden of depression and increased the occurrence of depressive symptoms in general population [2]. The urgency of implementing mental health services to address new barriers to care persuaded clinicians to use telemedicine to follow patients and stay in touch with them, and to explore digital therapeutics (DTx) as potential tools for clinical intervention [2]. The combination of antidepressants and psychotherapy is widely recommended for depression by international guidelines [3] but is less frequently applied in real-world practice. Commonly used treatments are pharmacological, but while being effective, some aspects such as adherence to the drug regimen, residual symptoms, resistance, lack of information, and stigma may hinder successful treatment. In case of less severe depression, standalone psychological therapies should be the first-line treatment option [3], but access to trained psychotherapists remains inequitable. DTx are evidence-based therapies driven by software programs to treat or complement treatment of a specific disease. DTx are classified as Medical Devices, and given their therapeutic purpose, they need to be validated through randomized controlled clinical trials, as for drug-based therapies. In the last 10 years, studies of digital interventions have proliferated; these studies demonstrate that digital interventions increase remission rates and lower the severity of depressive symptoms compared with waitlist, treatment as usual, and attention control conditions [4]. Despite the efficacy demonstrated in clinical trials, many of these tools never reach real-life patients; thus, it might be necessary to implement DTx in the public health system to expand access to valid treatment options. In this framework, DTx represent a good opportunity to help people with depression receive optimal psychotherapeutic care [5].

Patient-Factors Influencing the 2-Year Trajectory of Mental and Physical Health in Prostate Cancer Patients.

This study aimed to examine the physical and mental Quality of Life (QoL) trajectories in prostate cancer (PCa) patients participating in the Pros-IT CNR study. QoL was assessed using the Physical (PCS) and Mental Component Score (MCS) of Short-Form Health Survey upon diagnosis and two years later. Growth mixture models were applied on 1158 patients and 3 trajectories over time were identified for MCS: 75% of patients had constantly high scores, 13% had permanently low scores and 12% starting with low scores had a recovery; the predictors that differentiated the trajectories were age, comorbidities, a family history of PCa, and the bowel, urinary and sexual functional scores at diagnosis. In the physical domain, 2 trajectories were defined: 85% of patients had constantly high scores, while 15% started with low scores and had a further slight decrease. Two years after diagnosis, the psychological and physical status was moderately compromised in more than 10% of PCa patients. For mental health, the trajectory analysis suggested that following the compromised patients at diagnosis until treatment could allow identification of those more vulnerable, for which a level 2 intervention with support from a non-oncology team supervised by a clinical psychologist could be of help.

Cross-cultural differences in men on active surveillance' anxiety: a longitudinal comparison between Italian and Dutch patients from the Prostate cancer Research International Active Surveillance study.

BACKGROUND: Men diagnosed with localized prostate cancer (PCa) on active surveillance (AS) have shown to cope with anxiety caused by living with an 'untreated cancer' and different factors can influence the tolerance level for anxiety in these patients. The present study analyzes Italian (Milan) and Dutch (Rotterdam) men prospectively included in the Prostate cancer International Active Surveillance (PRIAS) trial, aiming to explore whether socio-demographic factors (i.e. age, relationship status, education, nationality) may be relevant factors in conditioning the level of anxiety at AS entry and over time. METHODS: Italian and Dutch men participating in the IRB-approved PRIAS study, after signing an informed consent, filled in the Memorial Anxiety Scale for PCa (MAX-PC) at multiple time points after diagnosis. A linear mixed model was used to assess the relationship between the level of patient's anxiety and time spent on AS, country of origin, the interaction between country and time on AS, patients' relationship status and education, on PCa anxiety during AS. RESULTS: 823 MAX-PC questionnaires were available for Italian and 307 for Dutch men, respectively. Median age at diagnosis was 64 years (IQR 60-70 years) and did not differ between countries. On average, Dutch men had a higher total MAX-PC score than Italian men. However, the level of their anxiety decreased over time. Dutch men on average had a higher score on the PCa anxiety sub-domain, which did not decrease over time. Minimal differences were observed in the sub-domains PSA anxiety and fear of recurrence. CONCLUSION: Significant differences in PCa anxiety between the Italian and Dutch cohorts were observed, the latter group of men showing higher overall levels of anxiety. These differences were not related to the socio-demographic factors we studied. Although both PRIAS-centers are dedicated AS-centers, differences in PCa-care organization (e.g. having a multidisciplinary team) may have contributed to the observed different level of anxiety at the start and during AS. Trial registration This study is registered in the Dutch Trial Registry ( www.trialregister.nl ) under NL1622 (registration date 11-03-2009), 'PRIAS: Prostate cancer Research International: Active Surveillance-guideline and study for the expectant management of localized prostate cancer with curative intent'.

Breast cancer patient perspective on opportunities and challenges of a genetic test aimed to predict radio-induced side effects before treatment: Analysis of the Italian branch of the REQUITE project.

AIM: To explore breast cancer patient's perspective on future genetic testing for prediction of toxicity after breast radiotherapy (RT). MATERIALS AND METHODS: The study involved patient enrolled in the Italian branch of the REQUITE project conducted at the National Cancer Institute in Milan. Semi-structured interviews were conducted within one month from the end of radiotherapy treatment by two radiation oncologists and a radiotherapy technician previously trained by a clinical psychologist with experience in the oncology field. Semi-structured interviews are characterized by a set of pre-defined questions and developed ad hoc by researchers in Leicester within the REQUITE project. The interview questions investigated interest in undergoing the genetic test and expectations on its usefulness and disadvantages. RESULTS: Eighteen interviews were conducted and analysed. Forty-five initial codes were combined into nine themes which were then clustered in two main macro-areas (i) Opportunities and (ii) Challenges. Overall, all patients understand the aim of the genetic test and considered its intrinsic opportunity to make the physician more confident with the treatment. Regarding side effects, most of patients felt prepared to RT but not without fear. Many women considered important to have the largest and reliable information, also about negative experiences. Prevailing emotions were anxiety and fear but not connected to genetic test's result. CONCLUSIONS: A genetic test could be an opportunity because generate knowledge and give patients a dynamic role in the decision-making approach. Prediction of single patient radiosensitivity before RT could prompt suggestion to entail a more and more tailored radiation treatment in the era of personalized approach.

How do prostate cancer patients navigate the active surveillance journey? A 3-year longitudinal study.

OBJECTIVE: To investigate whether prostate cancer (PCa) patients' coping strategies (i.e., fighting spirit, anxious preoccupation, fatalism, helplessness/hopelessness, and avoidance) significantly change during the first 3-year follow-up period of active surveillance (AS). MATERIALS AND METHODS: Altogether, 104 patients on AS completed the Mini-Mental Adjustment to Cancer (Mini-MAC) at baseline (T0), at 10 and 12 months after diagnostic biopsy (T1 and T2, respectively) and then at 24- (T3) and 36-month (T4) follow-up. Paired samples T test was used to detect statistically significant changes over time. Changes ≥ 1 point (or ≤ - 1) were hypothesized to be clinically relevant. RESULTS: During the first 3 years on AS, men experienced decreased anxiety, avoidance thoughts/behaviors, and fight-against-cancer attitudes, and these changes were found to be statistically significant. When considering clinically significant changes between inclusion in AS (T0) and 3-year follow-up (T4), avoidance decreased in 19% of patients. CONCLUSIONS: Most patients were observed to have adopted functional coping strategies at baseline, which were maintained through the first 3 years on AS. Overall, men on AS may perceive increasing control over their cancer and comfort with the AS protocol over time and experience slight decreases in anxious preoccupation, cancer-related avoidance thoughts and behaviors, and fight-against-cancer reactions. For those men who find it difficult to cope with AS, psychological monitoring and interventions could be helpful throughout the monitoring journey.

Making Active Surveillance a path towards health promotion: A qualitative study on prostate cancer patients' perceptions of health promotion during Active Surveillance.

OBJECTIVE: Health promotion is a key aspect for health outcomes of prostate cancer (PCa) patients. However, it has been poorly explored among patients following monitoring programmes, for example Active Surveillance (AS). This study aimed to explore PCa patients' perceptions of health promotion during AS. METHODS: An explorative qualitative research design was adopted. Four focus groups were used to collected data from 24 men enrolled in the Prostate Cancer Research International: AS (PRIAS) protocol. A thematic analysis with an inductive approach was performed. RESULTS: Participants described promoting health during AS as challenged by mental, age-related, informational and organisational issues. It was reported as an effort to stay in the present with a positive outlook, despite the worries for the future ("the mental theme"). It was perceived as impacted by being older and having to manage physical and mental struggles related to age ("the life-course theme"). It depended, in their accounts, on obtaining reliable information and personalised education ("the educational theme"). Finally, it was related on taking responsibility on the care process ("the organisational theme"). CONCLUSION: This study suggested ways of promoting health during AS that can help healthcare professionals and organisations building a "health-promoting AS," able to improve overall health outcomes.

Quality of life in active surveillance and the associations with decision-making-a literature review.

Several studies have been conducted on the quality of life (QoL) in men with low risk prostate cancer (PCa) who choose active surveillance (AS). While recent reviews have shown a lack of consistency among the available QoL-studies, a few key points have been identified, including decision-making (DM)-related issues and their potential effect on QoL. The importance of this theme has also been recently highlighted by the international task force of the European School of Oncology. However, to our knowledge, there are no studies that have specifically marshalled scientific knowledge on the association between DM and QoL among men with low-risk PCa undergoing AS. We performed a literature review to fill this gap, taking a systematic approach to retrieving and selecting articles that included both DM and QoL measures. Among the 272 articles retrieved, we selected nine observational, quantitative articles with both DM and QoL measures. The most considered DM aspects within these studies were decisional conflict and preference for the patient's role in the DM process, as well as health-related QoL aspects. The studies included 42 assessments of the relationship between an empirical measure of DM and an empirical measure of QoL. Among these assessments, 23 (55%) were both positive and significant. They mostly concerned the relationship between patient-related (decisional self-efficacy, decisional control and knowledge) and external (presence of social support, collaborative role within the DM process, and influence of different physicians) DM aspects, as well as the QoL after choice. The findings of these studies revealed key challenges to research and clinical practice related to DM and QoL in AS. These include adopting a person-centred perspective where clinicians, caregivers and their interactions are also included in evaluations and where the psychosocial existential experience of individuals within the DM and AS journey is considered. Much more attention needs to be paid to the DM process after diagnosis, as well as to all the other moments where patients may have to or want to review their decision. Healthcare professionals play a key role in enabling men to make informed decisions and to take care of their health and well-being during AS. There is still work that needs to be done in training healthcare professionals from different disciplines to work together in a model of shared DM and AS tailored to the needs of low-risk PCa patients and their family members.

Italian cultural adaptation of the Memorial Anxiety for Prostate Cancer scale for the population of men on active surveillance.

PURPOSE: The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) is a self-report questionnaire that was developed in English to assess prostate cancer (PCa)-related anxiety. The aim of this study was to perform a cultural adaptation for the tool to be used in a population of Italian men on active surveillance (AS). METHODS: A total of 222 patients with localized PCa who were recruited for the Prostate Cancer Research International: Active Surveillance (PRIAS) protocol completed the MAX-PC. Psychometric analysis was performed to assess reliability indexes. A Spearman rank correlation was used to test the association between MAX-PC scales and other questionnaires and was used for longitudinal analysis. RESULTS: Cronbach coefficients and item to total correlation demonstrated good internal consistency. Some items related to the repetition of the PSA test showed a large floor effect and thus were poorly effective in measuring anxiety for PSA testing in patients on AS. Confirmatory factor analysis partly failed to reproduce the structure of the original version. A modified version of MAX-PC, excluding the items with a large floor effect, was thus considered for AS patients. Factor analysis on this version demonstrated considerable consistency with the presence of 3 subscales: anxiety related to PCa, anxiety related to PSA testing, and anxiety related to the fear of tumor progression. Longitudinal analysis showed an acceptable validity over time. The MAX-PC was correlated with the anxious preoccupation subscale of the Mini-Mental Adjustment to Cancer scale. CONCLUSIONS: A slightly modified version of the MAX-PC was developed for use in Italian men on AS. This instrument appears to be a valid and reliable tool that measures anxiety in men with PCa who are enrolled in AS programs.

Eleven-year management of prostate cancer patients on active surveillance: what have we learned?

PURPOSE: To evaluate the outcomes of active surveillance (AS) on patients with low-risk prostate cancer (PCa) and to identify predictors of disease reclassification. METHODS: In 2005, we defined an institutional AS protocol (Sorveglianza Attiva Istituto Nazionale Tumori [SAINT]), and we joined the Prostate Cancer Research International: Active Surveillance (PRIAS) study in 2007. Eligibility criteria included clinical stage ≤T2a, initial prostate-specific antigen (PSA) <10 ng/mL, and Gleason Pattern Score (GPS) ≤3 + 3 (both protocols); ≤25% positive cores with a maximum core length containing cancer ≤50% (SAINT); and ≤2 positive cores and PSA density <0.2 ng/mL/cm3 (PRIAS). Switching to active treatment was advised for a worsening of GPS, increased positive cores, or PSA doubling time <3 years. Active treatment-free survival (ATFS) was assessed using the Kaplan-Meier method. Factors associated with ATFS were evaluated with a multivariate Cox proportional hazards model. RESULTS: A total of 818 patients were included: 200 in SAINT, 530 in PRIAS, and 88 in personalized AS monitoring. Active treatment-free survival was 50% after a median follow-up of 60 months. A total of 404/818 patients (49.4%) discontinued AS: 274 for biopsy-related reclassification, 121/404 (30%) for off-protocol reasons, 9/404 (2.2%) because of anxiety. Biopsy reclassification was associated with PSA density (hazard ratio [HR] 1.8), maximum percentage of core involvement (HR 1.5), positive cores at diagnostic biopsy (HR 1.6), older age (HR 1.5), and prostate volume (HR 0.6) (all p<0.01). Patients from SAINT were significantly more likely to discontinue AS than were the patients from PRIAS (HR 1.65, p<0.0001). CONCLUSIONS: Five years after diagnosis, 50% of patients with early PCa were spared from active treatment. Wide inclusion criteria are associated with lower ATFS. However, at preliminary analysis, this does not seem to affect the probability of unfavorable pathology.

Setting an Agenda for Assessment of Health-related Quality of Life Among Men with Prostate Cancer on Active Surveillance: A Consensus Paper from a European School of Oncology Task Force.

BACKGROUND: Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them. OBJECTIVE: The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies. DESIGN, SETTING, AND PARTICIPANTS: A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that ≥80% of ESO TF members rated as useful/important were retained. Items with a 50-80% rating were discussed to reach final agreement. RESULTS AND LIMITATIONS: Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making-related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge. CONCLUSIONS: HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine. PATIENT SUMMARY: An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts' indications lay a foundation for future research and clinical practice.

Lifestyle interventions to improve the quality of life of men with prostate cancer: A systematic review of randomized controlled trials.

Improving quality of life is a key issue for patients with prostate cancer (PCa). Lifestyle interventions could positively impact the quality of life of patients. However, there is no clear-cut understanding of the role of diet, exercise and risky behaviour reduction in improving the quality of life of men with PCa. The aim of this review was to systematically summarize randomized controlled trials on lifestyle in PCa patients with quality of life as main outcome. 17 trials were included. Most of them referred to exercise interventions (71%) and involved men undergoing androgen deprivation therapy (47%). Exercise studies yielded the greater amount of positive results on quality of life outcomes (67%), followed by dietary interventions (50%) and combined lifestyle interventions (33%). In particular, supervised exercise programs with resistance training sessions were the ones producing greater convincing evidence for benefits on quality of life. Further studies with high methodological quality providing adequate information to develop evidence-based, personalized lifestyle interventions that can effectively ameliorate PCa-related quality of life are needed.

"What if ": decisional regret in patients who discontinued active surveillance.

PURPOSE: To investigate the presence of regret in patients about having followed an active surveillance (AS) protocol. The secondary aim was to identify variables that influence regret. METHODS: From February 2006 to May 2014, 204 patients discontinued the AS protocols and were invited to enter the study. Sociodemographic variables were collected at AS enrollment, together with health-related quality of life (Functional Assessment of Cancer Therapy-Prostate version [FACT-P]) and coping (Mini-Mental Adjustment to Cancer). Patients were asked to complete a Treatment Regret Scale as well as the FACT-P questionnaire. Clinical data were gathered, as well as time of stay within the AS protocol, reason for discontinuing AS, kind of post-AS treatment, and time elapsed since AS discontinuation. Questionnaires were completed by 105 patients (51.5% of those who had been invited to enter the study). RESULTS: Most of the patients had a low or null degree of regret on the Treatment Regret Scale from 0 to 100 (82/105 patients [78.1%] obtained a score <30, and about 30% of the sample had a score equal to zero). Only 5 patients (4.7%) scored 60 or more, indicating some degree of regret. None of the statistical tests between regret scores and a number of analyzed variables reached significance. CONCLUSIONS: These results show that the degree of regret about following an AS protocol and after its discontinuation because of entering active treatment was very low. The regret after AS was not related to sociodemographic or clinical factors.

How does active surveillance for prostate cancer affect quality of life? A systematic review.

CONTEXT: The optimal management of screen-detected, localised prostate cancer remains controversial, related to overtreatment issues of screening and the nonrandomised evidence base. Active surveillance (AS) aims to delay or avoid curative therapy but may potentially harm patients' well-being through living with untreated prostate cancer. OBJECTIVE: To systematically review the literature on quality of life (QoL) in patients undergoing AS. EVIDENCE ACQUISITION: Embase, Medline, Psychinfo, Cochrane Central, Web of Science, and PubMed databases were searched in May 2014 using quality of life, active surveillance, prostate cancer, their synonyms, and targeted manual searches. The psychological dimensions related to health-related QoL (HRQoL) outcomes were anxiety and depression, distress, decisional conflict, and mental health. EVIDENCE SYNTHESIS: Ten clinical and research-based AS studies worldwide measured HRQoL and related psychological facets in six cross-sectional studies and four cohorts (follow-up: 9-36 mo; published: 2006-2014). Six studies were linked to published AS cohorts. In total, 966 men undergoing AS (mean: 102 per study) were assessed (mean age: 66 yr). AS patients had good overall HRQoL scores, which were comparable or better than those of patients undergoing postradical treatment (comparator group in four studies), men's partners (one study) and population-based data (three studies). Anxiety and depression scores were favourable. Selection bias may be present, as none were randomised comparisons. Decreased psychological well-being may be partly predicted by AS patients' baseline and clinical characteristics. CONCLUSIONS: Patients undergoing AS reported good QoL and did not appear to suffer major negative psychological impacts. Longer follow-up is required as well as investigation into which patients are predisposed to negative impact and leaving AS prematurely. PATIENT SUMMARY: We reviewed the published evidence for quality-of-life impact on men with prostate cancer being monitored by active surveillance. The men who were on active surveillance usually reported good levels of well-being and did not appear to suffer major negative psychological impacts. The research findings suggest little presence of anxiety and depression and high overall quality of life related to their disease. However, there are few long-term studies, so more high-quality research is needed to make definitive recommendations.

Clinical and psychological telemonitoring and telecare of high risk heart failure patients.

We conducted a trial of telemonitoring and telecare for patients with chronic heart failure leaving hospital after being treated for clinical instability. Eighty patients were randomized before hospital discharge to a usual care group (n=40: follow-up at the outpatient clinic) or to an integrated management group (n=40: patients learned to use a handheld PDA and kept in touch daily with the monitoring centre). At enrolment, the groups were similar for all clinical variables. At one-year follow-up, integrated management patients showed better adherence, reduced anxiety and depression, and lower NYHA class and plasma levels of BNP with respect to the usual care patients (e.g. NYHA class 2.1 vs 2.4, P<0.02). Mortality and hospital re-admissions for congestive heart failure were also reduced in integrated management patients (P<0.05). Integrated management was more expensive than usual care, although the cost of adverse events was 42% lower. In heart failure patients at high risk of relapse, the regular acquisition of simple clinical information and the possibility for the patient to contact the clinical staff improved drug titration, produced better psychological status and quality of life, and reduced hospitalizations for heart failure.

Living with untreated prostate cancer: predictors of quality of life.

PURPOSE OF REVIEW: To summarize the literature on the predictors of quality of life (QoL) of patients with prostate cancer (PCa) on active surveillance and to highlight both risk factors of poor QoL and resilience factors that facilitate decision-making and promote adherence to active surveillance. RECENT FINDINGS: Four main clusters of predicting variables have been highlighted: decision-making-related issues (patient's perception of the influence of physicians on the choice of active surveillance was related to higher decisional conflict; smaller amount of time to make a decision was predictive of poor QoL); demographic variable (such as marital status, age, and education level); psychological individual and interpersonal characteristics (neuroticism and impaired mental health were found to be associated with poor QoL, whereas positive outlook toward cancer was predictive of considering active surveillance as an effective management option for PCa); and patients' perceptions of cancer characteristics (prostate-specific antigen and number of positive cores). SUMMARY: Men who choose active surveillance may present unique care needs. Identification of the most relevant risk factors for poor QoL can be useful to physicians who aim to target the psychosocial issues that patients and their families may need to address promptly. Predictive models could be used to identify active surveillance patients who present features of psychosocial vulnerability and to develop tailored psychoeducational interventions.

Predictors of health-related quality of life and adjustment to prostate cancer during active surveillance.

BACKGROUND: Active surveillance (AS) is emerging as an alternative approach to limit the risk of overtreatment and impairment of quality of life (QoL) in patients with low-risk localised prostate cancer. Although most patients report high levels of QoL, some men may be distressed by the idea of living with untreated cancer. OBJECTIVE: To identify factors associated with poor QoL during AS. DESIGN, SETTING, AND PARTICIPANTS: Between September 2007 and March 2012, 103 patients participated in the Prostate Cancer Research International Active Surveillance (PRIAS) QoL study. Mental health (Symptom Checklist-90), demographic, clinical, and decisional data were assessed at entrance in AS. Health-related QoL (HRQoL) Functional Assessment of Cancer Therapy-Prostate version and Mini-Mental Adjustment to Cancer outcomes were assessed after 10 mo of AS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariate logistic regression models were used to identify predictors of low (<25th percentile) HRQoL, adjustment to cancer, and a global QoL index at 10 mo after enrollment. RESULTS AND LIMITATIONS: The mean age of the study patients was 67 yr (standard deviation: ±7 yr). Lack of partner (odds ratio [OR]: 0.08; p=0.009) and impaired mental health (OR: 1.2, p=0.1) were associated with low HRQoL (p=0.006; area under the curve [AUC]: 0.72). The maladaptive adjustment to cancer (p=0.047; AUC: 0.60) could be predicted by recent diagnosis (OR: 3.3; p=0.072). Poor global QoL (overall p=0.02; AUC: 0.85) was predicted by impaired mental health (OR: 1.16; p=0.070) and time from diagnosis to enrollment in AS <5 mo (OR: 5.52; p=0.009). Influence of different physicians on the choice of AS (OR: 0.17; p=0.044), presence of a partner (OR: 0.22; p=0.065), and diagnostic biopsy with >18 core specimens (OR: 0.89; p=0.029) were predictors of better QoL. Limitations of this study were the small sample size and the lack of a control group. CONCLUSIONS: Factors predicting poor QoL were lack of a partner, impaired mental health, recent diagnosis, influence of clinicians and lower number of core samples taken at diagnostic biopsy. Educational support from physicians and emotional/social support should be promoted in some cases to prevent poor QoL.