Trusting relationships between patients with non-curative cancer and healthcare professionals create ethical obstacles for informed consent in clinical trials: a grounded theory study.

BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a 'trusting relationship' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients' and healthcare professionals' perspectives. METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding. RESULTS: The 'Trusting relationship' with healthcare professionals underpinned patient motivation to participate, with many patients 'feeling lucky' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of 'What the doctor thinks is best' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to 'please' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, 'Is it possible to provide balanced information?'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process. CONCLUSION: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the 'experts'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient's life is limited.

Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.

BACKGROUND: Patients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships. AIM: We convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients' and partners' sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship. METHODS: The guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995-2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR). OUTCOMES: Guidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel. RESULTS: The guidelines account for patients' cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship. CLINICAL IMPLICATIONS: The guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer. STRENGTHS & LIMITATIONS: The strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries. CONCLUSION: The guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research. Wittmann D, Mehta A, McCaughan E, et al. Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel. J Sex Med 2022;19:1655-1669.

A constructivist grounded theory study on decision-making for treatment choice among Black African and Black Caribbean prostate cancer survivors.

OBJECTIVE: Despite Black African (BA) and Black Caribbean (BC) men having a disproportionately high risk (1 in 4) of developing prostate cancer (CaP), there is limited understanding of their decision-making for treatment choice. This study explored decision-making for treatment choice among BA/BC men treated for CaP. METHODS: Using constructivist grounded theory, face-to-face, Skype and telephone interviews were conducted with 25 Black men (8 BA, 17 BC) recruited in England between October 2016 and March 2018. Data were analysed using constant comparison until saturation was achieved. RESULTS: Data analysis yielded three broad categories: 'coming to terms with the prostate cancer diagnosis', 'getting empowerment through information-seeking' and 'choosing a treatment option'. Priority for survival substantially motivated BA/BC men to take up radical treatment for their CaP. However, decision-making for a particular treatment option was a more complex process which was shaped by an intersection between biological, behavioural, medical, personal and cultural factors. CONCLUSIONS: Healthcare providers need to consider the complexity of decision-making process for CaP treatment among BA/BC men and tailor cancer care services to reflect cultural sensitivity and person-centredness. This could potentially minimise treatment decision regrets and improve men's psychological wellbeing along the CaP survivorship pathway.

Immediate bereavement experiences when a parent of dependent children has died of cancer: Funeral directors' perspectives.

When a parent of dependent children dies, families are often unsure if and how children could be part of the immediate bereavement period. Children excluded can be more susceptive to negative outcomes. In-depth interviews explored funeral directors' (N = 23) experiences of providing a service to families in the immediate bereavement period, when a parent dies from cancer. Findings highlighted funeral directors can have an important role in guiding families through the distressing immediate bereavement period. Recommendations are discussed surrounding a pastoral role of the funeral director in the immediate bereavement period.

Experiences of Support for Sexual Dysfunction in Men With Prostate Cancer: Findings From a U.K.-Wide Mixed Methods Study.

BACKGROUND: Men with prostate cancer (PCa) often experience sexual dysfunction following diagnosis and treatment, yet little is known about the support they receive to deal with this. AIM: To explore men's experiences of support for sexual dysfunction following PCa diagnosis. METHODS: This study included a U.K.-wide survey of men 18-42 months post-diagnosis of PCa, identified through cancer registries. The survey measured sexual function and the extent to which men perceived sexual dysfunction to be a problem (Expanded Prostate Cancer Index Composite-26), access to and experience of medications, devices, and specialist services for sexual dysfunction, and included a free-text question for further comments. Analysis focussed on men who reported poor sexual function, which they considered a moderate or big problem. Descriptive statistics explored the characteristics of men offered intervention and those that found this helpful. Free-text responses were analyzed using thematic analysis. OUTCOME: The main outcome of this study was to assess access to and experience of medications, devices, and specialist services for sexual dysfunction. RESULTS: 39.0% of all survey respondents (13,978/35,823) reported poor sexual function, which they considered a moderate or big problem. 51.7% of these men were not offered any intervention to aid sexual functioning. 71.9% of those offered an intervention reported trying it, of whom 48.7% found the intervention helpful. Men treated with surgery or brachytherapy were most likely to be offered an intervention. Medication was the most commonly offered intervention and 39.3% of those who tried medication found this helpful. Although offered less often, approximately half of the men who tried devices or attended specialist services found the intervention helpful. Free-text responses indicated that barriers to accessing support included inadequate information and support from healthcare professionals, embarrassment, negative views about treatment options, concerns about side effects and safety, and inconsistencies between secondary and primary care. Barriers to continuing use included limited effectiveness of treatments, inadequate ongoing support, and funding constraints. Drivers of sexual recovery included patient proactivity and persistence with trying different treatment options and ongoing support from health professionals. CLINICAL IMPLICATIONS: There is an urgent need to ensure that all men are offered, and have equal access to, sexual care support, with referral to specialist services when required. STRENGTHS & LIMITATIONS: This study presents data from a large, U.K.-wide, population-based study of men with PCa and includes quantitative and qualitative findings. The possibility of non-response bias should, however, be considered. CONCLUSION: There are significant shortcomings in the support offered to U.K. men with sexual dysfunction following diagnosis and treatment for PCa which need to be addressed. Watson E, Wilding S, Matheson L, et al. Experiences of Support for Sexual Dysfunction in Men With Prostate Cancer: Findings From a U.K.-Wide Mixed Methods Study. J Sex Med 2021;18:515-525.

Providing care to parents dying from cancer with dependent children: Health and social care professionals' experience.

OBJECTIVE: Parents often feel ill-equipped to prepare their dependent children (<18 years old) for the death of a parent, necessitating support from professionals. The aim of this study is to explore health and social care professionals' (HSCPs) experiences and perceptions of providing supportive care to parents regarding their children, when a parent is dying from cancer. METHODS: Semi-structured qualitative interviews were conducted with 32 HSCPs, including nurses, allied health professionals, social workers and doctors from specialist or generalist roles, across acute or community sectors. RESULTS: HSCPs' perceptions of the challenges faced by many families when a parent is dying from cancer included: parental uncertainties surrounding if, when and how to tell the children that their parent was dying, the demands of managing everyday life, and preparing the children for the actual death of their parent. Many HSCPs felt ill-equipped to provide care to parents at end of life concerning their children. The results are discussed under two themes: (1) hurdles to overcome when providing psychological support to parents at end of life and (2) support needs of families for the challenging journey ahead. CONCLUSIONS: There appears to be a disparity between HSCPs' awareness of the needs of families when a parent is dying and what is provided in practice. HSCPs can have a supportive role and help equip parents, as they prepare their children for the death of their parent. Appropriate training and guideline provision could promote this important aspect of end of life care into practice.

A qualitative systematic review of the social eating and drinking experiences of patients following treatment for head and neck cancer.

PURPOSE: Patients living with and beyond head and neck cancer (HNC) often have long-term, functional challenges as a result of treatment. A key functional challenge relates to eating and drinking; often associated with physical, emotional, and social difficulties. Eating and drinking with family members and friends can become a struggle, increasing the risk of social isolation and loneliness. This systematic review aims to identify and synthesise the literature on the experiences of social eating and drinking for patients following treatment for HNC. METHODS: Six electronic databases (Pubmed, Web of Science, CINAHL, EMBASE, PsychINFO, and Scopus) were systematically searched using subject headings and free-text word searches in February 2020. Citation chaining and Google Scholar were used to identify grey literature. PRISMA procedures were followed. RESULTS: Of 6910 records identified, 24 studies met the inclusion criteria. Synthesis of the research findings results in two major themes: (1) the experience of loss associated with social eating and drinking, and (2) adjusting and support to promote social eating and drinking. CONCLUSION: Losses associated with social eating affect a patient's psychological and emotional well-being and impact on close relationships. To promote positive participation in social eating, patients were more likely to seek and receive support from someone within their close social network, rather than a healthcare professional. Family and friends are an essential source of support and are integral in facilitating engagement with social eating following treatment for HNC. Future interventions should promote family orientated resources, incorporating self-management strategies.

'Don't forget the children': a qualitative study when a parent is at end of life from cancer.

PURPOSE: Preparation for end of life is one of the greatest challenges faced by parents with cancer who have dependent children (< 18 years old), with requirement for support from professionals. The aim of this study is to explore how parents can be best supported in relation to their children, when a parent is at end of life from cancer. METHODS: This is an interpretive qualitative study, using 79 semi-structured interviews with parents at end of life (n3), bereaved parents (n21), health and social care professionals (HSCPs) (n32) and funeral directors (n23). Data were analysed thematically and triangulated. RESULTS: Parents are central to preparing their children for the death of a parent. Striving for everyday ordinariness, maximising social networks, maintaining hope and making preparations for the future are helpful for families when a parent is at end of life. Most HSCPs were unaware of the challenges faced by parents at end of life, and psychosocial support was often left outside the caring realm. As a result, funeral directors noted complexities faced by the families after the death. Results are discussed under four themes: (1) communication with the children as a process, (2) coping throughout the unfolding end of life experience, (3) tension and complexities at end of life and (4) preparing for the future. CONCLUSIONS: Parents should be reassured that by involving the children early in the end of life experience when the ill-parent is 'well enough' to parent enables them to be actively involved in supporting their child through one of the greatest life changing event. A number of recommendations are discussed for professionals.

'Living in parallel worlds' - bereaved parents' experience of family life when a parent with dependent children is at end of life from cancer: A qualitative study.

BACKGROUND: When a parent of dependent children (<18 years old) is at end of life from cancer, this has a profound impact on the family. Children less prepared for the death of a parent are more susceptive to poorer psychosocial adjustment in later life. There is a lack of understanding from the literature surrounding what support parents require, and how they navigate this end of life experience. AIM: To explore bereaved parents' experience and needs for families when a parent is at end of life from cancer with dependent children. DESIGN: In-depth, semi-structured qualitative interviews were conducted with 21 bereaved mothers and fathers, identified from the general public, a family support service and hospice. Data were analysed thematically. RESULTS: Parents often live in 'parallel worlds' throughout the end of life period. In one world, 'living in the moment', cherishing the ordinariness of family life, remaining hopeful treatment will prolong life, whilst adapting as the illness unfolds. The other world presents as 'intermitted glimpses that death is approaching', shadowed with painful emotional concerns surrounding their children and the future. At the end, death rapidly approaches, characterised as suddenly 'falling off the cliff'; placing significant demands on the well-parent. CONCLUSIONS: Amidst challenges, clinicians should provide parents with clear information surrounding a poor prognosis, so families can plan and prepare for parental death. There is a need for healthcare professionals to engage, encourage and equip parents, as they prepare their children throughout the end of life experience for the inevitable death of a parent.

Efficacy, Use, and Acceptability of a Web-Based Self-management Intervention Designed to Maximize Sexual Well-being in Men Living With Prostate Cancer: Single-Arm Experimental Study.

BACKGROUND: Sexual dysfunction is a frequent side effect associated with different prostate cancer treatment approaches. It can have a substantial impact on men and their partners and is associated with increased psychological morbidity. Despite this, sexual concerns are often not adequately addressed in routine practice. Evidence-based web-based interventions have the potential to provide ongoing information and sexual well-being support throughout all stages of care. OBJECTIVE: The aim of this study is to examine the efficacy of a web-based self-management intervention designed to maximize sexual well-being in men living with prostate cancer and explore user perspectives on usability and acceptability. METHODS: We used a single-arm study design, and participants were provided with access to the 5-step intervention for a period of 3 months. The intervention content was tailored based on responses to brief screening questions on treatment type, relationship status, and sexual orientation. Efficacy was assessed by using two-tailed, paired sample t tests for comparing the mean differences between pre- and postintervention measurements for exploring the participants' self-reported knowledge and understanding, sexual satisfaction, and comfort in discussing sexual issues. Usability and acceptability were determined based on the program use data and a postintervention survey for exploring perceived usefulness. RESULTS: A total of 109 participants were recruited for this study. Significant postintervention improvements at follow-up were observed in the total scores (out of 20) from the survey (mean 12.23/20 points, SD 2.46 vs mean 13.62/20, SD 2.31; t88=9.570; P=.001) as well as in individual item scores on the extent to which the participants agreed that they had sufficient information to manage the impact that prostate cancer had on their sex life (mean 2.31/4 points, SD 0.86 vs mean 2.57/4, SD 0.85; t88=3.660; P=.001) and had the potential to have a satisfying sex life following treatment (mean 2.38/4 points, SD 0.79 vs mean 3.17/4, SD 0.78; t88=7.643; P=.001). The median number of intervention sessions was 3 (range 1-11), and intervention sessions had a median duration of 22 minutes (range 8-77). Acceptable usability scores were reported, with the highest result observed for the question on the extent to which the intervention provided relevant information. CONCLUSIONS: This study provides evidence on the efficacy of a tailored web-based intervention for maximizing sexual well-being in men living with prostate cancer. The results indicate that the intervention may improve one's self-perceived knowledge and understanding of how to manage sexual issues and increase self-efficacy or the belief that a satisfactory sex life could be achieved following treatment. The findings will be used to refine the intervention content before testing as part of a larger longitudinal study for examining its effectiveness.

Nothing to lose: a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent.

BACKGROUND: Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging. AIM: To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved. METHODS: In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process. RESULTS: 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model. CONCLUSION: This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.

Quality of life in men living with advanced and localised prostate cancer in the UK: a population-based study.

BACKGROUND: Little is known about the health-related quality of life (HRQOL) of men living with advanced prostate cancer. We report population-wide functional outcomes and HRQOL in men with all stages of prostate cancer and identify implications for health-care delivery. METHODS: For this population-based study, men in the UK living 18-42 months after diagnosis of prostate cancer were identified through cancer registration data. A postal survey was administered, which contained validated measures to assess functional outcomes (urinary incontinence, urinary irritation and obstruction, bowel, sexual, and vitality and hormonal function), measured with the Expanded Prostate Cancer Index Composite short form (EPIC-26), plus questions about use of interventions for sexual dysfunction) and generic HRQOL (assessed with the 5-level EuroQol five dimensions questionnaire [EQ-5D-5L] measuring mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, plus a rating of self-assessed health). Log-linear and binary logistic regression models were used to compare functional outcomes and HRQOL across diagnostic stages and self-reported treatment groups. Each model included adjustment for age, socioeconomic deprivation, and number of other long-term conditions. FINDINGS: 35 823 (60·8%) of 58 930 men responded to the survey. Disease stage was known for 30 733 (85·8%) of 35 823 men; 19 599 (63·8%) had stage I or II, 7209 (23·4%) stage III, and 3925 (12·8%) stage IV disease. Mean adjusted EPIC-26 domain scores were high, indicating good function, except for sexual function, for which scores were much lower. Compared with men who did not receive androgen deprivation therapy, more men who received the therapy reported moderate to big problems with hot flushes (30·7% [95% CI 29·8-31·6] vs 5·4% [5·0-5·8]), low energy (29·4% [95% CI 28·6-30·3] vs 14·7% [14·2-15·3]), and weight gain (22·5%, 21·7-23·3) vs 6·9% [6·5-7·3]). Poor sexual function was common (81·0%; 95% CI 80·6-81·5), regardless of stage, and more than half of men (n=18 782 [55·8%]) were not offered any intervention to help with this condition. Overall, self-assessed health was similar in men with stage I-III disease, and although slightly reduced in those with stage IV cancer, 23·5% of men with metastatic disease reported no problems on any EQ-5D dimension. INTERPRETATION: Men diagnosed with advanced disease do not report substantially different HRQOL outcomes to those diagnosed with localised disease, although considerable problems with hormonal function and fatigue are reported in men treated with androgen deprivation therapy. Sexual dysfunction is common and most men are not offered helpful intervention or support. Service improvements around sexual rehabilitation and measures to reduce the effects of androgen deprivation therapy are required. FUNDING: The Movember Foundation, in partnership with Prostate Cancer UK.

"Man in the driving seat": A grounded theory study of the psychosocial experiences of Black African and Black Caribbean men treated for prostate cancer and their partners.

OBJECTIVE: Evidence suggests that treatment side-effects of prostate cancer (CaP) substantially affect the psychosocial well-being of affected men and their partners. However, this phenomenon is poorly understood among high risk (1 in 4) Black African (BA)/Black Caribbean (BC) men and their partners, as they are currently under-represented in global research on CaP survivorship. This study explored the psychosocial experiences of BA/BC men with CaP and their partners in the United Kingdom as they lived through the side effects of CaP treatment within their own sociocultural and marital contexts. METHODS: Using constructivist grounded theory methodology, interviews and focus groups were conducted with eligible men (n = 25), partners (n = 11), and health care professionals (HCPs) (n = 11) recruited in England. Data were iteratively analysed using constant comparison following the key stages of initial, focused, and theoretical coding until saturation was achieved. RESULTS: Data analysis culminated in the development of a substantive theory "man in the driving seat," which describes the experiences of BA/BC men with CaP and their partners within their context. Culturally informed gender roles and identities influenced how men and partners responded and coped with the side effects of CaP treatment. There was a hierarchy of power within the BA/BC relationship, in which men were dominantly positioned as leaders, whilst partners mostly operated from a supportive but "accepting" position. CONCLUSION: Inclusive and culturally sensitive individual and couple-focused psychosocial support, which is devoid of stereotyping and recognises the experiences of both BA/BC men and their partners is recommended.

Challenges and support needs of parents and children when a parent is at end of life: A systematic review.

BACKGROUND: Preparing children for the death of a parent is challenging. Parents are often uncertain if and how to communicate and support their children. Many parents feel it is protecting their children by not telling them about the prognosis. Children less prepared for parental death from a terminal illness are more susceptive to later adversities. To facilitate coping and moderate for such adversities, there is a need to gain insight and understand the experience and challenges confronted by families. AIM: This review synthesised evidence on the experiences of parents and children when a parent is at end of life to discern their challenges, support needs and factors that facilitated good practice. DESIGN: Mixed-methods systematic review. DATA SOURCES: Four electronic databases (CINAHL, PubMed, PsycINFO and Ovid MEDLINE) using MeSH terms and word searches in October 2018. Studies were not limited by year of publication, language or country. Grey literature searches were also completed on Google Scholar and OpenGrey. RESULTS: In all, 7829 records were identified; 27 qualitative and 0 quantitative studies met the inclusion criteria. Eight descriptive themes were identified, further categorised into two broad themes: (1) barriers and facilitators in sharing the news that a parent is dying and (2) strategies to manage the changing situation. CONCLUSION: Lack of understanding in relation to the parent's prognosis, denial and feeling ill-equipped were suggested as barriers for parents to share the news with their children. Engagement with social networks, including extended family relatives and peers, and maintaining routines such as attending school were suggested supportive by parents and children. Findings are limited primarily to White, middle-class two-parent families. A number of areas for future research are identified.

"Hard to reach, but not out of reach": Barriers and facilitators to recruiting Black African and Black Caribbean men with prostate cancer and their partners into qualitative research.

Access and recruitment barriers may have contributed to the underrepresentation of Black African/Caribbean men and their partners in current psychosocial research related to prostate cancer survivors. Whilst some studies have explored recruitment barriers and facilitators from participants' perspectives, little is known from researchers' point of view. This paper aimed to address this gap in the literature. Recruitment strategies included the following: cancer support groups, researchers' networks, media advertisement, religious organisations, National Health Service hospitals and snowball sampling. Thirty-six eligible participants (men = 25, partners = 11) were recruited into the study. Recruitment barriers comprised of gate-keeping and advertisement issues and the stigma associated with prostate cancer disclosure. Facilitators which aided recruitment included collaborating with National Health Service hospitals, snowball sampling, flexible data collection, building rapport with participants to gain their trust and researcher's attributes. Findings highlight that "hard to reach" Black African/Caribbean populations may be more accessible if researchers adopt flexible but strategic and culturally sensitive recruitment approaches. Such approaches should consider perceptions of stigma associated with prostate cancer within these communities and the influence gatekeepers can have in controlling access to potential participants. Increased engagement with healthcare professionals and gatekeepers could facilitate better access to Black African/Caribbean populations so that their voices can be heard and their specific needs addressed within the healthcare agenda.

Treatment for erectile dysfunction among older men in Northern Ireland.

BACKGROUND: Erectile dysfunction is common among older men; however, diagnosis and treatment compared to reported prevalence is low. We aim to identify the degree to which older men are offered treatment for the condition and determine the level of unmet need within Northern Ireland (NI). METHODOLOGY: Analysis of data collected using a cross-sectional survey was conducted for men aged ≥60 years with data weighted to the NI population by age and deprivation. Respondents answered questions on sociodemographic factors, health-related characteristics, ability to function sexually, level of sexual interest and activity, and any treatment offered to improve erections in the last 3 years. Results are presented as proportions reporting treatment receipt, with differences by respondent characteristics assessed using chi-square tests and multivariable logistic regression. RESULTS: Among 2597 respondents, 46.5% reported erectile dysfunction. One quarter (25.8%) recalled being offered either medication, devices, or specialised services to improve erections. The offer of treatment was associated with younger age, being separated or divorced, higher number of long-term conditions, and greater interest in sex. Of men reporting erectile dysfunction and offered medication, 28.8% found them helpful and currently use them. CONCLUSIONS: As a result of not being offered treatment or not finding treatment useful, 93% of men reporting erectile dysfunction have no help with the condition. This is a likely consequence of treatment availability through the NHS in NI, but also suggests that healthcare professionals need to engage more proactively with older men, discussing sexual health routinely and following up those treated for the condition.

Urinary, bowel and sexual health in older men from Northern Ireland.

OBJECTIVES: To provide data on the prevalence of urinary, bowel and sexual dysfunction in Northern Ireland (NI), to act as a baseline for studies of prostate cancer outcomes and to aid service provision within the general population. SUBJECTS AND METHODS: A cross-sectional postal survey of 10 000 men aged ≥40 years in NI was conducted and age-matched to the distribution of men living with prostate cancer. The EuroQoL five Dimensions five Levels (EQ-5D-5L) and 26-item Expanded Prostate Cancer Composite (EPIC-26) instruments were used to enable comparisons with prostate cancer outcome studies. Whilst representative of the prostate cancer survivor population, the age-distribution of the sample differs from the general population, thus data were generalised to the NI population by excluding those aged 40-59 years and applying survey weights. Results are presented as proportions reporting problems along with mean composite scores, with differences by respondent characteristics assessed using chi-squared tests, analysis of variance, and multivariable log-linear regression. RESULTS: Amongst men aged ≥60 years, 32.8% reported sexual dysfunction, 9.3% urinary dysfunction, and 6.5% bowel dysfunction. In all, 38.1% reported at least one problem and 2.1% all three. Worse outcome was associated with increasing number of long-term conditions, low physical activity, and higher body mass index (BMI). Urinary incontinence, urinary irritation/obstruction, and sexual dysfunction increased with age; whilst urinary incontinence, bowel, and sexual dysfunction were more common among the unemployed. CONCLUSION: These data provide an insight into sensitive issues seldom reported by elderly men, which result in poor general health, but could be addressed given adequate service provision. The relationship between these problems, raised BMI and low physical activity offers the prospect of additional health gain by addressing public health issues such as obesity. The results provide essential contemporary population data against which outcomes for those living with prostate cancer can be compared. They will facilitate greater understanding of the true impact of specific treatments such as surgical interventions, pelvic radiation or androgen-deprivation therapy.

Evaluating a psychosocial intervention for men with prostate cancer and their partners: Outcomes and lessons learned from a randomized controlled trial.

AIM: This study evaluated the process and outcome of a psychosocial intervention for men with prostate cancer and their partners. As more men survive prostate cancer, they and their partners need help and support to help them cope with the physical and psychosocial effects of the disease and treatment. There is a lack of psychosocial interventions for men with prostate cancer and their partners. METHODS: A randomized controlled trial was conducted with 34 participants to measure the effects of the intervention on selected psychosocial outcomes, post-intervention and at one month' follow-up. The nine-week program (CONNECT) consisted of three group and two telephone sessions. It focused on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. The outcomes, measured by validated tools were: self-efficacy, quality of life, symptom distress, communication, uncertainty and illness benefits. RESULTS: The men in the intervention group did better on two outcomes (communication and support) than controls. Partners in the intervention group did better than controls on most outcomes. Less participants than expected participated in the trial. The reasons for non-participation included partners not wishing to participate, men not interested in group work, and not understanding the core purpose of the intervention. The cost of training facilitators and for delivering the intervention appeared to be low. CONCLUSION: The knowledge generated from this study will be beneficial for all those grappling with the challenges of developing, implementing and evaluating complex psychosocial interventions. This study has also highlighted the difficulties in recruiting men and their partners in clinical trials.

Online support groups for women with breast cancer.

BACKGROUND: Survival rates for women with a diagnosis of breast cancer continue to improve. However, some women may experience physical, psychological and emotional effects post diagnosis, throughout treatment and beyond. Support groups can provide opportunities for people to share their experiences and learn from others. As the number of online support groups increases, more and more women with breast cancer will likely access them. OBJECTIVES: To assess effects of online support groups on the emotional distress, uncertainty, anxiety, depression and quality of life (QoL) of women with breast cancer. SEARCH METHODS: We searched for trials in the Cochrane Breast Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 4), MEDLINE, Embase and PsycINFO on 2 May 2016, and we handsearched journals and reference lists. We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) search portal and clinicaltrials.gov on 2 May 2016. SELECTION CRITERIA: We included randomised controlled trials (RCTs) assessing effects of online support groups on women with a diagnosis of breast cancer and women who have completed breast cancer treatment. We included studies comparing online support groups with a usual care group, and studies comparing two or more types of online support groups (without a usual care group). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We presented outcome data using mean differences (MDs) and standardised mean differences (SMDs) along with 95% confidence intervals (CIs), and we used the fixed-effect model when appropriate. We assessed the quality of the body of evidence using the GRADE approach. MAIN RESULTS: We included six studies (492 women) that assessed online support groups for women with breast cancer. Online support groups in these six trials lasted from six to 30 weeks. Women participated in these groups between 1.5 and 2.5 hours per week, and investigators conducted all studies in the USA. Participants were predominantly white and well educated and were moderate to high earners. Four studies compared an online support group versus a control group, and the other two compared a 'moderated' versus a 'peer-led' online support group, and a 'standard' versus an 'enhanced' online support group, respectively.None of the included studies measured 'emotional distress' or uncertainty. One study (78 women) for which data for analysis were missing reported no positive effects of online support on 'distress' and 'cancer-specific distress' versus support provided by a control group. Two studies measured anxiety: One study (72 women) found no difference in anxiety at the end of the intervention between the online support group and the control group (MD -0.40, 95% CI -6.42 to 5.62; low-quality evidence), and the second study (184 women) reported a reduction in anxiety levels at the end of the intervention when comparing the 'standard' support group (run by participants without prompting from health professionals) versus an 'enhanced' online support group (in which participants were specifically asked by the researcher to respond to one another's need for support).Five studies (414 women) measured depression. Three studies compared depression in the online support group with depression in the control group. Pooled data from two studies (120 women) showed a small to moderate reduction in depression in the online support group compared with control groups at the end of the intervention (SMD -0.37, 95% CI -0.75 to 0.00; very low-quality evidence). The third study, a pilot study (30 women), provided no data for analysis but reported no difference in depression between participants in support and control groups at the end of the intervention. Of the remaining two studies that measured depression, one study (60 women) provided no extractable data for comparison but reported no difference in depressive symptoms between a 'moderated' and a 'peer-led' support group; the other study (184 women) reported greater reduction in depression in the 'standard' support group than in the 'enhanced' online support group.Three studies measured quality of life. One pilot study (30 women) provided limited data for analysis but reported no change in quality of life at the end of the intervention. Only two studies (140 women) provided data for pooling and showed no positive effects on quality of life at four months post intervention compared with controls (SMD -0.11, 95% CI -0.47 to 0.24; very low-quality evidence). At 12 months post intervention, one study (78 women) reported that the intervention group did not attain better quality of life scores than the control group (MD -10.89, 95% CI -20.41 to -1.37; low-quality evidence).We found no data for subgroup analyses on stage of disease, treatment modality and types and doses of interventions. No studies measured adverse effects. AUTHORS' CONCLUSIONS: This review did not find the evidence required to show whether participation in online support groups was beneficial for women with breast cancer, because identified trials were small and of low or very low quality. Large, rigorous trials with ethnically and economically diverse participants are needed to provide robust evidence regarding the psychosocial outcomes selected for this review.

Facilitators' delivery of a psychosocial intervention in a controlled trial for men with prostate cancer and their partners: a process evaluation.

AIM: The aim of this paper was to report the process evaluation of facilitators' delivery of a psychosocial intervention (called CONNECT), in a randomized controlled trial, to men with prostate cancer and their partners. BACKGROUND: There is a lack of information on the process of implementing psychosocial interventions in controlled trials and, in particular, on the role and performance of facilitators who deliver them. Yet, this information is crucial in assessing whether these interventions are effective or not and why. DESIGN: Qualitative design. METHODS: Semi-structured qualitative interviews and diaries were used to collect data (January-October 2012) from four facilitators and a co-facilitator. Data were analysed using the Miles et al. RESULTS: Five themes were discernible. These were 'difficulties to keep to the structure of the intervention', 'selective coverage of topics', 'partner participation', 'overall impression of the group and telephone sessions' and 'perceived benefits to participants'. Issues such as not keeping to the aim of the intervention, deviating from the content and/or reluctance in discussing sensitive issues such as sexual health may mean that the psychosocial effects of the intervention may not have been fully realized. CONCLUSIONS: These findings will be useful for further development and evaluation of the intervention. A tentative conceptual framework of factors, related to facilitators, influencing the fidelity of interventions in the context of controlled trials, is offered. This model, which requires further development and testing, will be useful for researchers worldwide who are involved in developing interventions and training facilitators.