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.

Parent's with incurable cancer: 'Nuts and bolts' of how professionals can support parents to communicate with their dependent children.

OBJECTIVE: Parents with incurable cancer are often uncertain how, what and when is best to tell their children about their poor prognosis and prepare them for the actual death. Despite parents' desire and need for support from health and social care professionals (HSCPs), this is often lacking. HSCPs feel ill-equipped, identifying a need for an evidence-based communication framework for professionals to use in practice, promoting parent-child communication at end of life. METHODS: A systematic process, involving a systematic review and data from 76 semi-structured, face-to-face qualitative interviews from three participant populations, including HSCPs (n = 32), bereaved parents (n = 21) and funeral directors (n = 23) were triangulated. This informed the development of the 'Talking, Telling and Sharing': End of life framework (6 W Grid), guided by an expert group. RESULTS: An evidence-based, theory-driven communication framework has been developed. This provides a mechanism for HSCPs to proactively and directly engage with patients, addressing their parent-child communication concerns. CONCLUSION: Clear, evidence-based communication frameworks can enhance patient-provider communication in practice, particularly around sensitive and complex issue. PRACTICE IMPLICATIONS: There is a need for HSCPs to encourage parents to start these difficult conversations soon after receiving the poor prognosis, to avoid crisis management when the ill-parent is actively dying or throughout the immediate bereavement period.

Effects of a Brief E-Learning Resource on Sexual Attitudes and Beliefs of Healthcare Professionals Working in Prostate Cancer Care: A Pilot Study.

Sexual issues and treatment side effects are not routinely discussed with men receiving treatment for prostate cancer, and support to address these concerns is not consistent across settings. This study evaluates a brief e-learning resource designed to improve sexual wellbeing support and examine its effects on healthcare professionals' sexual attitudes and beliefs. Healthcare professionals (n = 44) completed an online questionnaire at baseline which included a modified 12-item sexual attitudes and beliefs survey (SABS). Follow-up questionnaires were completed immediately after the e-learning and at 4 weeks. Data were analysed using one-way, repeat measures ANOVAs to assess change in attitudes and beliefs over time. Significant improvements were observed at follow-up for a number of survey statements including 'knowledge and understanding', 'confidence in discussing sexual wellbeing' and the extent to which participants felt 'equipped with the language to initiate conversations'. The resource was seen as concise, relevant to practice and as providing useful information on potential side effects of treatment. In brief, e-learning has potential to address barriers to sexual wellbeing communication and promote delivery of support for prostate cancer survivors. Practical methods and resources should be included with these interventions to support implementation of learning and long-term changes in clinical behaviour.

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.

'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.

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.

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.