[Which non pharmacological interventions should be offered to patients treated with androgen deprivation therapy for prostate cancer? A systematic review]. / Quelles interventions non médicamenteuses proposer aux patients traités par hormono-suppression pour un cancer de la prostate ? Revue systématique de la littérature.

AIM: Prostate cancer is a frequent disease and one of the main treatments used is androgen deprivation therapy, which is a therapy with disabling side effects. Non-pharmacological interventions (NPIs) are evidenced based, non-invasive interventions on human health. They are classified into five categories (physical, psychological, nutritional, digital, elemental). The NPIs sphere is booming and still remains underused in this context. METHODS: A systematic review concerning randomized controlled trials was executed according to the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). We used the "Medline" and "Kalya Research" databases. After searching and selecting eligible publications, we included 37 randomized controlled trials. RESULTS: The majority of articles concerned physical NPIs with 30 clinical studies, 3 publications dealt with nutritional NPIs, 2 with psychological NPIs and 2 articles concerned elemental NPIs. No publication about digital NPI was found. All of the studies aimed to manage and improve the side effects of treatment. No elemental NPI has demonstrated benefit. Only one psychological NPI and one nutritional NPI were effective. Five types of physical NPI protocols have shown efficacy. The main benefits related to physical abilities, body composition, osteoporosis, quality of life, fatigue, reduced cardiovascular risk and finally anxiety and depression. CONCLUSION: Non-pharmacological interventions, especially physical ones, are effective in managing and reducing the side effects associated with androgen deprivation therapy and should be offered to patients in this context.

A randomized comparison of group mindfulness and group cognitive behavioral therapy vs control for couples after prostate cancer with sexual dysfunction.

BACKGROUND: Sexual dysfunction is the most common and most distressing consequence of prostate cancer (PCa) treatment and has been shown to directly affect the sexual function and quality of life of survivors' partners. There are currently no established therapies to treat the emotional and psychological burden that sexual issues impose on the couple after PCa. AIM: Our study examined the impact of 2 therapies-cognitive behavioral therapy (CBT) and mindfulness therapy-on sexual, relational, and psychological outcomes of PCa survivor and partner couples. METHODS: PCa survivors (n = 68) who self-reported current sexual problems after PCa treatments and their partners were randomized to 4 consecutive weeks of couples' mindfulness therapy, couples' CBT, or no treatment (control). OUTCOMES: Couples' sexual distress, survivors' sexual satisfaction, and couples' relationship satisfaction, quality of life, psychological symptoms (anxiety and depression), and trait mindfulness were measured at baseline, 6 weeks after treatment, and 6 months after treatment. RESULTS: Sexual distress and sexual satisfaction were significantly improved 6 weeks after the CBT and mindfulness interventions as compared with the control group, but only sexual distress remained significantly improved at 6 months. Relationship satisfaction decreased and more so for partners than survivors. There were increases in domains of quality of life for survivors vs their partners 6 months after treatments and an overall increase in general quality of life for couples 6 weeks after mindfulness. There were no significant changes in psychological symptoms and trait mindfulness. Qualitative analysis showed that the mindfulness intervention led to greater personal impact on couple intimacy after the study had ended. CLINICAL IMPLICATIONS: CBT and mindfulness can be effective treatments for helping couples adapt to and cope with changes to their sexual function after PCa treatments and could help improve the most common concern for PCa survivors-that is, couples' sexual intimacy-after cancer, if added to routine clinical care. STRENGTHS AND LIMITATIONS: We used established standardized treatment manuals and highly sensitive statistical methodology and accounted for covariable factors and moderators of primary outcomes. Due to difficulty in recruitment, we had a smaller control group than treatment, reducing our power to detect between-group differences. Our sample was mostly White, heterosexual, and affluent, thereby limiting the generalizability. CONCLUSION: This is the first randomized clinical trial to test and demonstrate benefits among PCa survivors and partners' sexual outcomes after CBT and mindfulness as compared with a nontreatment control group.

Mindfulness-based stress reduction for men on active surveillance for prostate cancer and their spouses: Design and methodology of a randomized controlled trial.

BACKGROUND: Although active surveillance (AS) is an increasingly adopted treatment paradigm for management of very low risk prostate cancer, many men and their partners face a variety of AS-related psychosocial stressors. Stressors may include anxiety and fear of progression, which may negatively affect short- and long-term psychosocial adjustment and influence early withdrawal from AS in order to seek definitive therapies such as surgery or radiation. Here we describe the protocol for an NCI-funded trial, which seeks to examine the efficacy of mindfulness training compared with a time/attention-matched health promotion control condition in a geographically generalizable sample of men on AS and their spouses. METHODS: Using a randomized, controlled, partially double-blinded study design, this study involves the delivery of 8 weeks of standardized mindfulness training (MBSR; mindfulness-based stress reduction) and patient reported outcomes over a 12-month period (proposed enrollment of 80 men on AS and spouses), compared with a health promotion control (proposed enrollment of 80 men on AS and spouses) that has been matched for time and attention. Baseline (T1) measures (e.g., anxiety, fear of progression, quality of life) are administered just prior to randomization to the two study arms, followed by repeated assessments at 2 months (T2), 6 months (T3) and 12 months (T4). CONCLUSION: This study has the potential to offer men and their partners on AS with important educational and self-regulatory skills to better cope and adjust with known stressors related to being placed on this protocol.

The effects of androgen deprivation on working memory and quality of life in prostate cancer patients: The roles of hypothalamic connectivity.

BACKGROUND: Androgen deprivation therapy (ADT) has been associated with adverse effects on the brain. ADT alters testosterone levels via its action on the hypothalamus-pituitary-gonadal axis and may influence hypothalamic functions. Given the wide regional connectivity of the hypothalamus and its role in regulating cognition and behavior, we assessed the effects of ADT on hypothalamic resting state functional connectivity (rsFC) and their cognitive and clinical correlates. METHODS: In a prospective observational study, 22 men with nonmetastatic prostate cancer receiving ADT and 28 patients not receiving ADT (controls), matched in age, years of education, and Montreal Cognitive Assessment score, participated in N-back task and quality of life (QoL) assessments and brain imaging at baseline and at 6 months. Imaging data were processed with published routines and the results of a group by time flexible factorial analysis were evaluated at a corrected threshold. RESULTS: ADT and control groups did not differ in N-back performance or QoL across time points. Relative to controls, patients receiving ADT showed significantly higher hypothalamus-right mid-cingulate cortex (MCC) and precentral gyrus (PCG) rsFC during follow-up versus baseline. Further, the changes in MCC and PCG rsFC were correlated positively with the change in QoL score and 0-back correct response rate, respectively, in patients with undergoing ADT. CONCLUSION: Six-month ADT affects hypothalamic functional connectivity with brain regions critical to cognitive motor and affective functions. Elevated hypothalamic MCC and PCG connectivity likely serve to functionally compensate for the effects of ADT and sustain attention and overall QoL. The longer-term effects of ADT remain to be investigated.

What interventions affect the psychosocial burden experienced by prostate cancer patients undergoing active surveillance? A scoping review.

PURPOSE: Living with untreated prostate cancer (PCa) may cause anxiety and uncertainty in men undergoing active surveillance (AS). Developing a psychosocial support program for such patients might promote psychosocial well-being and patient engagement. This review aims to identify interventions with the potential to influence the psychosocial burden of prostate cancer patients undergoing AS. METHODS: A scoping review was conducted in accordance with the PRISMA Extension for Scoping Reviews Checklist. A systematic search was conducted in six databases and included publications dating from 2009. All available and eligible evidence was included in this review. RESULTS: After screening 2824 articles, 12 studies were included in the review: nine quantitative, one qualitative, and two mixed method papers. The relative strength of these studies was limited and the quality of most was moderate. CONCLUSIONS: The described interventions can be categorized into three major themes: information and education, coping and (psycho)social support, and lifestyle. Psychosocial support for men undergoing AS should entail involvement of family and spouse during the decision-making process, tailored information about PCa treatments, risks, benefits, protocols, lifestyle adjustments, and complementary and alternative medicine. Assessment and promotion of effective coping and self-management strategies are recommended. Healthcare providers should actively promote physical activity and nutritional improvements. Physical activity programs may also be helpful in facilitating peer support, which is especially important for men with limited social support. Future research should investigate combining interventions to increase efficacy and optimize supportive care during AS.

Evaluation of Hypofractionated Radiation Therapy Use and Patient-Reported Outcomes in Men With Nonmetastatic Prostate Cancer in Australia and New Zealand.

Importance: Randomized clinical trials in prostate cancer have reported noninferior outcomes for hypofractionated radiation therapy (HRT) compared with conventional RT (CRT); however, uptake of HRT across jurisdictions is variable. Objective: To evaluate the use of HRT vs CRT in men with nonmetastatic prostate cancer and compare patient-reported outcomes (PROs) at a population level. Design, Setting, and Participants: Registry-based cohort study from the Australian and New Zealand Prostate Cancer Outcomes Registry (PCOR-ANZ). Participants were men with nonmetastatic prostate cancer treated with primary RT (excluding brachytherapy) from January 2016 to December 2019. Data were analyzed in March 2021. Exposures: HRT defined as 2.5 to 3.3 Gy and CRT defined as 1.7 to 2.3 Gy per fraction. Main Outcomes and Measures: Temporal trends and institutional, clinicopathological, and sociodemographic factors associated with use of HRT were analyzed. PROs were assessed 12 months following RT using the Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form questionnaire. Differences in PROs were analyzed by adjusting for age and National Comprehensive Cancer Network risk category. Results: Of 8305 men identified as receiving primary RT, 6368 met the inclusion criteria for CRT (n = 4482) and HRT (n = 1886). The median age was 73.1 years (IQR, 68.2-77.3 years), 2.6% (168) had low risk, 45.7% (2911) had intermediate risk, 44.5% (2836) had high-/very high-risk, and 7.1% (453) had regional nodal disease. Use of HRT increased from 2.1% (9 of 435) in the first half of 2016 to 52.7% (539 of 1023) in the second half of 2019, with lower uptake in the high-/very high-risk (1.9% [4 of 215] to 42.4% [181 of 427]) compared with the intermediate-risk group (2.2% [4 of 185] to 67.6% [325 of 481]) (odds ratio, 0.26; 95% CI, 0.15-0.45). Substantial variability in the use of HRT for intermediate-risk disease remained at the institutional level (median 53.3%; range, 0%-100%) and clinician level (median 57.9%; range, 0%-100%) in the last 2 years of the study period. There were no clinically significant differences across EPIC-26 urinary and bowel functional domains or bother scores. Conclusions and Relevance: In this cohort study, use of HRT for prostate cancer increased substantially from 2016. This population-level data demonstrated clinically equivalent PROs and supports the continued implementation of HRT into routine practice. The wide variation in practice observed at the jurisdictional, institutional, and clinician level provides stakeholders with information that may be useful in targeting implementation strategies and benchmarking services.

An Exploration of the Rs of Radiobiology in Prostate Cancer.

OBJECTIVES: To explore the four Rs of radiobiology (Repair, Reoxygenation, Reassortment, and Repopulation) as a means to understand the effects of ionising radiation on biological tissue and subsequently as the basis for conventional fractionated treatment schedules. These radiobiological principles will form a rationale for combined regimens in prostate cancer treatment involving androgen deprivation therapy and radiation therapy and the associated toxicities of this approach will be discussed. DATA SOURCES: Electronic databases including CINAHL, MEDLINE, Scopus, professional websites, books and grey literature were searched using Google Scholar. CONCLUSION: It is important for nurses to understand the four Rs of radiobiology to grasp the effects of ionising radiation on biological tissue as the basis for conventional fractionated treatment schedules in prostate cancer. Men can experience a sequalae of physical and psychological side effects of treatment that can negatively impact quality of life. IMPLICATIONS FOR NURSING PRACTICE: Men can experience a range of unmet supportive care needs particularly related to informational, sexual, and psychological needs. For men affected by prostate cancer opting for radiation therapy (+/-) androgen deprivation therapy, nurses should ask targeted questions based on the Common Terminology Criteria for Adverse Events related to urinary and bowel function, potency and fatigue, and sexual health. We also recommend the use of holistic needs assessments to tailor self-management care plans. Evidence-based self-management advice should be provided in response to each man's unique needs.

Nursing Implications of Recent Changes in Management Practices for Metastatic Prostate Cancer.

OBJECTIVE: Prostate cancer is one of the most common male cancers in the world and accounts for substantial morbidity, mortality, loss of disability-adjusted life-years, and financial burden to patients and to the community. Metastatic prostate cancer has been managed for over 70 years with androgen deprivation therapy, but further life-prolonging therapies were not available until 2004. Since then, drugs such as docetaxel, abiraterone, enzalutamide, cabazitaxel, radium-223 dichloride, and (not available in Australia) sipuleucel-T have all demonstrated efficacy in prolongation of survival in castrate-resistant prostate cancer, and improvement in cancer-related morbidity. DATA SOURCES: Peer-reviewed scientific publications, Australian Government agency reports, and expert opinion. CONCLUSION: More recently, several of these agents have been given earlier in the treatment course to the hormone-sensitive metastatic setting, with even greater benefits in survival. These treatments have come at a cost: a literal financial cost to the community, and often to the patients and their families; and financial costs to the community to supply the drugs to those who need them. They also carry non-financial costs, including side effects of treatment, exacerbation of other co-morbidities, metabolic and bone health challenges, and psychological and social stresses, including those associated with longer survival with metastatic cancer. IMPLICATIONS FOR NURSING PRACTICE: The role of the nurse in management of these issues has never been more important. Nurses are often uniquely placed to educate men with prostate cancer and their families, screen for and identify adverse effects of treatment, and provide education and support not otherwise available. Nurses are central to the streamline of care coordination within the multidisciplinary team and the holistic care journey for men and their partners through the health care system. This review discusses several of these aspects to inform practice.

Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.

BACKGROUND: In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative. METHODS: This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment. DISCUSSION: This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors. TRIAL REGISTRATION: Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.

Religious Coping and Quality of Life Among Black and White Men With Prostate Cancer.

Prostate cancer is a significant impediment in men's lives as this condition often exacerbates stress and reduces quality of life. Faith can be a resource through which men cope with health crises; however, few studies examine how religion or spirituality can have implications for racial disparities in health outcomes among men. The purpose of this study is to assess the associations between religious coping and quality of life among black and white men with prostate cancer. Data for this investigation were drawn from the Diagnosis and Decisions in Prostate Cancer Treatment Outcomes Study that consisted of 624 black and white men with complete information on the primary outcome and predictor variables. The primary outcome for this study was overall quality of life as measured by the Functional Assessment of Cancer Therapy-Prostate questionnaire. The main independent variable was religious coping measured by 2 subscales capturing positive and negative forms of coping. Black men in the study had lower overall quality of life scores (134.6 ± 19.6) than their white peers (139.8 ± 14.1). Black men in the sample also had higher average positive religious coping scores (12.9 ± 3.3) than white men (10.3 ± 4.5). Fully adjusted linear regression models of the total sample produced results indicating that positive religious coping was correlated with an increase in quality of life (ß = .38, standard error [SE] = 0.18, P < .05). Negative religious coping was associated with a reduction in quality of life (ß = -1.48, SE = 0.40, P < .001). Faith-oriented beliefs or perceptions can have implications for quality of life among men with prostate cancer. Sensitivity to the role of religion, spirituality, and faith should be seen by providers of health care as potential opportunities for improved outcomes in patients with prostate cancer and survivors.

A prospective analysis of health-related quality of life in intermediate and high-risk prostate cancer patients managed with intensity modulated radiation therapy, with vs. without hormonal therapy.

INTRODUCTION: Combined radiotherapy and hormonal treatment are recommended for intermediate- and high-risk prostate cancer (CaP). This study compared the long-term effects on health-related quality of life (HRQoL) of intermediate- and high-risk CaP patients managed with radiation therapy (RT) with vs. without hormone therapy (HT). METHODS: Patients with intermediate- and high-risk CaP enrolled in the Center for Prostate Disease Research diagnosed from 2007 to 2017 were included. EPIC and SF-36 questionnaires were completed and HRQoL scores were compared for patients receiving RT vs. RT + HT at baseline (pretreatment), 6, 12, 24, 36, 48, and 60 months after CaP diagnosis. Longitudinal patterns of change in HRQoL were modeled using linear regression models, adjusting for baseline HRQoL, age at CaP diagnosis, race, comorbidities, National Comprehensive Cancer Network (NCCN) risk stratum, time to treatment, and follow-up time. RESULTS: Of 164 patients, 93 (56.7%) received RT alone and 71 (43.3%) received RT + HT. Both groups reported comparable baseline HRQoL. Patients receiving RT+HT were more likely to be NCCN high risk as compared to those receiving only RT. The RT + HT patients experienced worse sexual function, hormonal function, and hormonal bother than those who only received RT; however, HRQoL recovered over time for the RT + HT group. No significant differences were observed between groups in urinary and bowel domains or SF-36 mental and physical scores. CONCLUSION: Combined RT + HT treatment was associated with temporary lower scores in sexual and hormonal HRQoL compared with RT only. Intermediate- and high-risk CaP patients should be counseled about the possible declines in HRQoL associated with HT.

What Are the Experiences of Men Affected by Prostate Cancer Participating in an Ecological Momentary Assessment Study?

BACKGROUND: Within the cluster of self-report methodologies, ecological momentary assessment (EMA) is a method used in health services research whereby a participant repeatedly reports on affect, behaviors, symptoms, and cognitions as they occur in real time in the participant's natural environment. However, little is known about the impact of participating in an EMA study on individuals' experiences who are affected by prostate cancer. OBJECTIVES: The aims of this study were to explore the lived experiences of men affected by prostate participating in an EMA study and assess whether their participation in EMA alters their representation of their condition. METHODS: Participants (n = 12) were purposively recruited from 2 university teaching hospitals in Scotland. Semistructured interviews were conducted with men affected by prostate cancer following the completion of EMA data collection. Data were analyzed using thematic analysis. RESULTS: The lived experience of prostate cancer included 6 superordinate themes: isolation in the healthcare system, lack of shared care plans, informational support, coping with prostate cancer, fear of death and dying, and vocational rehabilitation. The organizing theme electronic diary as an intervention included 4 superordinate themes: changing self-management behaviors, habitual experience, changing perceptions, and diary in daily life. CONCLUSION: We observed that men participating in the EMA study described several methodological complexities, which need to be addressed through future research. IMPLICATIONS FOR PRACTICE: Importantly, there is a need for the health system to prioritize research and develop a more holistic approach to prostate cancer care in line with men's preferences and needs in the future.

Sexual Health Recovery For Prostate Cancer Survivors: The Proposed Role Of Acceptance And Mindfulness-Based Interventions.

INTRODUCTION: 1 in every 7 Canadian men is affected by prostate cancer. Given impressive advances in detection, treatment, and survival rates, there is a considerable focus on survivors' supportive care needs. Among the top unmet supportive care needs for prostate cancer survivors are concerns related to sexual health and intimacy. AIM: To provide a rationale for introducing mindfulness- and acceptance-based approaches into the role of psychosexual interventions aimed at improving sexual satisfaction among prostate cancer survivors (and their partners). METHODS: A literature review was performed to examine the prevalence of sexual difficulties after prostate cancer treatment and the efficacy of current pharmacologic and psychological treatment approaches. MAIN OUTCOME MEASURE: The main outcome measure was focused on sexual satisfaction in prostate cancer survivors. RESULTS: Current pharmacologic interventions for sexual difficulties after prostate cancer treatment are not fully meeting the needs of prostate cancer survivors and their partners. Conclusions cannot be drawn from existing psychological interventions because of methodologic inconsistencies. Additionally, the focus on erectile function as a measure of treatment effectiveness is likely to instill a greater sense of hopelessness and loss for prostate cancer survivors, which may exacerbate issues around sexual intimacy and satisfaction. An impressive body of evidence supports the role of mindfulness in improving women's sexual functioning and there is preliminary evidence suggesting the efficacy of this approach for improving men's sexual functioning. CONCLUSION: We propose that psychosexual interventions that prioritize mindfulness and acceptance-based frameworks may help men to tune into sensations while challenging the foci on performance and erections, thereby increasing the potential for improvement to sexual satisfaction among prostate cancer survivors. Bossio JA, Miller F, O'Loughlin JI, et al. Sexual Health Recovery for Prostate Cancer Survivors: The Proposed Role of Acceptance and Mindfulness-Based Interventions. Sex Med Rev 2019;7:627-635.

Follow-up care after treatment for prostate cancer: evaluation of a supported self-management and remote surveillance programme.

BACKGROUND: Alternative models of cancer follow-up care are needed to ameliorate pressure on services and better meet survivors' long-term needs. This paper reports an evaluation of a service improvement initiative for the follow-up care of prostate cancer patients based on remote monitoring and supported self-management. METHODS: This multi-centred, historically controlled study compared patient reported outcomes of men experiencing the new Programme with men experiencing a traditional clinic appointment model of follow-up care, who were recruited in the period immediately prior to the introduction of the Programme. Data were collected by self-completed questionnaires, with follow up measurement at four and eight months post-baseline. The primary outcome was men's unmet survivorship needs, measured by the Cancer Survivors' Unmet Needs Survey. Secondary outcomes included cancer specific quality of life, psychological wellbeing and satisfaction with care. The analysis was intention to treat. Regression analyses were conducted for outcomes at each time point separately, controlling for pre-defined clinical and demographic variables. All outcome analyses are presented in the paper. Costs were compared between the two groups. RESULTS: Six hundred and twenty-seven men (61%) were consented to take part in the study (293 in the Programme and 334 in the comparator group.) Regarding the primary measure of unmet survivorship needs, 25 of 26 comparisons favoured the Programme, of which 4 were statistically significant. For the secondary measures of activation for self-management, quality of life, psychological well-being and lifestyle, 20 of 32 comparisons favoured the Programme and 3 were statistically significant. There were 22 items on the satisfaction with care questionnaire and 13 were statistically significant. Per participant costs (British pounds, 2015) in the 8 month follow up period were slightly lower in the programme than in the comparator group (£289 versus £327). The Programme was acceptable to patients. CONCLUSION: The Programme is shown to be broadly comparable to traditional follow-up care in all respects, adding to evidence of the viability of such models.

"My gut feeling is we could do more..." a qualitative study exploring staff and patient perspectives before and after the implementation of an online prostate cancer-specific holistic needs assessment.

BACKGROUND: Men surviving prostate cancer report a wide range of unmet needs. Holistic needs assessments (HNA) are designed to capture these, but are traditionally paper-based, generic, and only carried out in secondary care despite national initiatives advocating a "shared care" approach. We developed an online prostate cancer-specific HNA (sHNA) built into existing IT healthcare infrastructure to provide a platform for service integration. Barriers and facilitators to implementation and use of the sHNA were explored from both the patients and healthcare professionals (HCPs) perspectives. METHODS: This qualitative study consisted of two phases. Phase 1 used semi-structured interviews to explore HCPs (n = 8) and patients (n = 10) perceptions of the sHNA, prior to implementation. Findings were used to develop an implementation strategy. Phase 2 used semi-structured interviews to explore HCPs (n = 4) and patients (n = 7) experienced barriers and motivators to using the sHNA, 9 to 12 months after implementation. Interviews were audio-recorded, transcribed verbatim and thematically analysed. Themes were mapped to the Theoretical Domains Framework. RESULTS: HCPs and patients anticipated many benefits from using the sHNA. Barriers to implementation included: confidence to work in depth with prostate cancer patients, organisational and cultural change, and patient factors. Our implementation strategy addressed these barriers by the provision of disease specific training delivered in part by a clinical nurse specialist; and a peer-led IT supporter. Following implementation HCPs and patients perceived the sHNA as beneficial to their practice and care, respectively. However, some patients experienced barriers in using the sHNA related predominately to symptom perception and time since treatment. HCPs suggested minor software refinements. CONCLUSIONS: This work supports the importance of identifying barriers and motivators to implementation, and using targeted action via the development of an implementation strategy to address these. Whilst this process should be on-going, undertaking this work at an early stage will help to optimise the implementation of the sHNA for future trials.

Meaningful differences and validity for the NCCN/FACT-P Symptom Index: An analysis of the ALSYMPCA data.

BACKGROUND: The Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. METHODS: Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. RESULTS: The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI-Disease-Related Symptoms-Physical, 0.5 points for NFPSI-Disease-Related Symptoms-Emotional, 1 to 1.5 points for NFPSI-Treatment Side Effects, and 0.5 to 1 point for NFPSI-Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. CONCLUSIONS: The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

Influences on health-care practitioners' promotion of physical activity to their patients with prostate cancer: a qualitative study.

INTRODUCTION Physical activity is beneficial for the physical and psychological health of patients with prostate cancer (PCa). Health-care practitioners are ideally positioned to promote physical activity to their patients. AIM To identify factors that influenced health care practitioners to either promote or not promote physical activity to their patients with PCa. METHODS Individual interviews were conducted with 16 Auckland-based health-care practitioners, including specialists (oncologists and urologists), physiotherapists and complementary and alternative (acupuncturists) health-care practitioners. Data were analysed using an inductive thematic approach. RESULTS Treatment-related factors (ie counteracting side-effects of hormone suppression treatment), longer life expectancy and risk factors for other conditions appeared to influence the promotion of physical activity to patients. Time constraints of consultations and complex medical issues were barriers to the promotion of physical activity. CONCLUSIONS This study found that a variety of health-care practitioners are providing some degree of physical activity advice to their patients with PCa. Collaborative practice among health-care practitioners to verbally reinforce the benefits of physical activity, coupled with referral to experts in physical activity promotion/rehabilitation (such as physiotherapists), should be encouraged for best practice care.

Efficacy of a hypnosis-based intervention to improve well-being during cancer: a comparison between prostate and breast cancer patients.

BACKGROUND: Prostate and breast cancer can have a lot of negative consequences such as fatigue, sleep difficulties and emotional distress, which decrease quality of life. Group interventions showed benefits to emotional distress and fatigue, but most of these studies focus on breast cancer patients. However, it is important to test if an effective intervention for breast cancer patients could also have benefits for prostate cancer patients. METHODS: Our controlled study aimed to compare the efficacy of a self-hypnosis/self-care group intervention to improve emotional distress, sleep difficulties, fatigue and quality of life of breast and prostate cancer patients. 25 men with prostate cancer and 68 women with breast cancer participated and were evaluated before (T0) and after (T1) the intervention. RESULTS: After the intervention, the breast cancer group showed positive effects for anxiety, depression, fatigue, sleep difficulties, and global health status, whereas there was no effect in the prostate cancer group. We showed that women suffered from higher difficulties prior to the intervention and that their oncological treatments were different in comparison to men. CONCLUSION: The differences in the efficacy of the intervention could be explained by the baseline differences. As men in our sample reported few distress, fatigue or sleep problems, it is likely that they did not improve on these dimensions. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02569294 and NCT03423927 ). Retrospectively registered in October 2015 and February 2018 respectively.

Exercise training as a novel primary treatment for localised prostate cancer: a multi-site randomised controlled phase II study.

Alternative management strategies for localised prostate cancer are required to reduce morbidity and overtreatment. The aim of this study was to evaluate the feasibility, safety and acceptability of exercise training (ET) with behavioural support as a primary therapy for low/intermediate risk localised prostate cancer. Men with low/intermediate-risk prostate cancer were randomised to 12 months of ET or usual care with physical activity advice (UCwA) in a multi-site open label RCT. Feasibility included acceptability, recruitment, retention, adherence, adverse events and disease progression. Secondary outcomes included quality of life and cardiovascular health indices. Of the 50 men randomised to ET (n = 25) or UCwA (n = 25), 92% (n = 46) completed 12 month assessments. Three men progressed to invasive therapy (two in UCwA). In the ET group, men completed mean: 140 mins per week for 12 months (95% CI 129,152 mins) (94% of target dose) at 75% Hrmax. Men in the ET group demonstrated improved body mass (mean reduction: 2.0 kg; 95% CI -2.9,-1.1), reduced systolic (mean: 13 mmHg; 95%CI 7,19) and diastolic blood pressure (mean:8 mmHg; 95% CI 5,12) and improved quality of life (EQ.5D mean:13 points; 95% CI 7,18). There were no serious adverse events. ET in men with low/intermediate risk prostate cancer is feasible and acceptable with a low progression rate to radical treatment. Early signals on clinically relevant markers were found which warrant further investigation.

Factors associated with the use of complementary and alternative medicines for prostate cancer by long-term survivors.

OBJECTIVE: To assess whether the use of complementary and alternative medicines therapies (CAMs) for prostate cancer and/or its treatment side effects by long-term survivors is associated with selected socio-demographic, clinical, health-related quality-of-life (HRQOL) and/or psychological factors. DESIGN, SETTING AND PARTICIPANTS: The Prostate Cancer Care and Outcomes Study (PCOS) is a population-based cohort study of men with prostate cancer who were aged less than 70 years at diagnosis in New South Wales, Australia. Included in these analyses were men who returned a 10-year follow-up questionnaire, which included questions about CAM use. METHODS: Validated instruments assessed patient's HRQOL and psychological well-being. Poisson regression with robust variance estimation was used to estimate the adjusted relative risks of current CAM use for prostate cancer according to socio-demographic, clinical, HRQOL and psychological factors. RESULTS: 996 of 1634 (61%) living PCOS participants completed the 10-year questionnaire. Of these 996 men, 168 (17%) were using CAMs for prostate cancer and 525 (53%) were using CAMs for any reason (including prostate cancer). Those using CAM for prostate cancer were more likely to be regular or occasional support group participants (vs. no participation RR = 2.02; 95%CI 1.41-2.88), born in another country (vs. Australian born RR = 1.59; 95%CI 1.17-2.16), have received androgen deprivation treatment (ADT) since diagnosis (RR = 1.60; 95%CI 1.12-2.28) or in the past two years (RR = 2.34; 95%CI 1.56-3.52). CAM use was associated with greater fear of recurrence (RR = 1.29; 95%CI 1.12-1.48), cancer-specific distress (RR = 1.15; 95%CI 1.01-1.30), cancer-specific hyperarousal (RR = 1.17; 95%CI 1.04-1.31), cancer locus of control (RR = 1.16; 95%CI 1.01-1.34) and less satisfaction with medical treatments (RR = 0.86; 95%CI 0.76-0.97), but not with intrusive thinking, cognitive avoidance, depression, anxiety or any HRQOL domains. CONCLUSIONS: In this study, about one in six long term prostate cancer survivors used CAMs for their prostate cancer with use centred around ADT, country of birth, distress, cancer control, fear of recurrence and active help seeking.