A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN):trial protocol

Background:- This randomised controlled trial (RCT) aims to evaluate the effectiveness of a guided self-help cognitive behavioural intervention to alleviate problematic hot flushes (HF) and night sweats (NS) in men who are undergoing prostate cancer treatment. The trial and the self-help materials have been adapted from a previous RCT, which showed that a cognitive behavioural intervention reduced the self-reported problem-rating of hot flushes in women with menopausal symptoms, and in women undergoing breast cancer treatment. We hypothesize that guided self-help will be more effective than usual care in reducing HF/NS problem-rating at post treatment assessment. Methods/Design:- Seventy men who are undergoing treatment for prostate cancer and who have been experiencing more than ten HF/NS weekly for over a month are recruited into the trial from urology clinics in London. They are randomly allocated to either a four-week self-help cognitive behavioural therapy (CBT) treatment or to their usual care (control group). The treatment includes information and discussion about hot flushes and night sweats in the context of prostate cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats, and advice on maintaining these changes.Prior to randomisation, men attend a clinical interview, undergo 24-48-hour sternal skin conductance monitoring, and complete pre-treatment questionnaires (e.g., problem-rating and frequency of hot flushes and night sweats; quality of life; mood; hot flush beliefs and behaviours). Post-treatment measures (sternal skin conductance and the above questionnaires) are collected four-six weeks later, and again at a six-month follow-up. Discussion:- MANCAN is the first randomised controlled trial of cognitive behavioural therapy for HF/NS for men that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by evaluating an evidence-based, non-medical treatment, which can be delivered by trained health professionals. Trial registration:- UK Clinical Research Network UKCRN10904

A randomised controlled trial of a brief cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN)

OBJECTIVE: Hot flushes and night sweats (HFNS) are experienced by up to 80% of prostate cancer patients undergoing androgen deprivation therapy (ADT). This study evaluates the effects of a guided self-help cognitive behavioural therapy (CBT) intervention on HFNS problem-rating (primary outcome), HFNS frequency, mood and health-related quality of life (secondary outcomes) in patients undergoing ADT. METHODS: Patients reporting treatment-induced HFNS were randomly assigned to CBT (n = 33) or treatment as usual (TAU) (n = 35), stratified for cancer type. The CBT intervention included a booklet, CD plus telephone contact during a 4-week period. Validated self-report questionnaires were completed at baseline, 6 weeks and 32 weeks after randomisation. The primary outcome was HFNS problem rating (perceived burden of HFNS) at 6 weeks after randomisation. Potential moderators and mediators were examined. Data analysis was conducted on a modified intention-to-treat basis. RESULTS: Compared with TAU, CBT significantly reduced HFNS problem rating (adjusted mean difference: -1.33, 95% CI -2.07 to -0.58; p = 0.001) and HFNS frequency (-12.12, 95% CI -22.39 to -1.84; p = 0.02) at 6 weeks. Improvements were maintained at 32 weeks, but group differences did not reach significance. There were significant reductions in negative HFNS Beliefs and Behaviours following CBT, but not in mood or quality of life. CONCLUSIONS: Guided self-help CBT appears to be a safe and effective brief treatment for men who have problematic HFNS following prostate cancer treatments. Further research might test the efficacy of the intervention in a multicentre trial

Can self-report questionnaires create illness cognitions in middle-aged men?

Objective: To examine the effect of questionnaire context on self-reported illness cognition. Design: A single-item measure of the perceived impact of lower urinary tract symptoms (LUTS) was embedded twice in a questionnaire battery completed by community-dwelling middle-aged males (N = 1,790). The impact measure was placed in two distinct questionnaire contexts; at the end of a general somatic symptoms questionnaire, and following an illness-specific symptoms questionnaire. The order of the two questionnaire contexts was counter-balanced in a random sub-sample. Main Outcome Measures: An established single-item measure of the perceived impact of LUTS. Results: Concordance between the two single-item measures was moderate. Scores on a single-item measure of impact were significantly lower when assessed immediately following the completion of a LUTS-specific questionnaire than when assessed following the completion of a general symptoms questionnaire. There was no evidence of order effects. The observed effect was moderated by the severity of LUTS such that the difference in perceived impact scores between contexts (where general symptoms context > illness-specific context) increased as urinary symptoms increased. Conclusion: Questionnaire context systematically influenced responses on self-report measures of illness impact. The magnitude of the context effect was largest in the highest quintile of LUTS severity, a difference of >0.5 on a scale with a range of 3. These findings may have implications for situations where patient reported outcome measures are used to evaluate healthcare interventions or inform treatment decisions

Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment

Up to 80% of men who receive androgen deprivation therapy report hot flushes and for many these are associated with reduced quality of life. However it is recognised that there are a number of barriers to men’s engagement with support to manage symptoms and improve quality of life. This qualitative study was embedded within a larger randomised controlled trial (MANCAN) of a guided self-help cognitive behavioural intervention to manage hot flushes resulting among men receiving androgen deprivation therapy. The study aimed to explore the engagement and experiences with the guided self-help intervention. Twenty men recruited from the treatment arm of the MANCAN trial participated in a semi-structured interview exploring acceptability of the intervention, factors affecting engagement and perceived usefulness of the intervention. Interviews were audio-recorded, transcribed verbatim and analysed using a Framework approach. Over two thirds of respondents (69%) reported reading the intervention booklet in full and over 90% reporting practising the relaxation CD at least once a week. Analysis of the interviews identified three super-ordinate themes and these related to changes in hot flush symptomatology (learned to cope with hot flushes in new ways), the skills that participants had derived from the intervention (promoting relaxation and reducing stressors), and to a broader usefulness of the intervention (broader impact of the intervention and skills). The present study identified positive engagement with a guided self-help intervention and that men applied the skills developed through the intervention to help them undertake general lifestyle changes. Psycho-educational interventions (e.g. cognitive behaviour therapy, relaxation, and positive lifestyle elements) offer the potential to be both effective and well received by male cancer survivors

Barriers to medical help-seeking among older men with prostate cancer

Objective:- Men's disinclination to seek medical help has been linked to higher rates of morbidity and mortality compared to women. However, previous studies were conducted predominantly with healthy, young, and middle-aged men. We explored the perceived medical barriers to help-seeking in older men with prostate cancer. Method:- 20 men with prostate cancer took part in semistructured interviews, which were analyzed using thematic analysis. Results:- Three themes were identified related to negative attitudes toward help-seeking: male gender role; fear of the health condition, medical and treatment procedures; and embarrassment as a consequence of medical examinations, communication with health (and nonhealth) professionals, and the disclosure of sexual-related symptoms. Conclusion:- The barriers identified in our study strengthen the evidence for the impact of traditional masculinity on help-seeking in men

Exploring the axion potential and axion walls in dense quark matter

We study the potential of the Quantum Chromodynamics axion in hot and/or dense quark matter, within a Nambu-Jona-Lasinio-like model that includes the coupling of the axion to quarks. Differently from previous studies, we implement local electrical neutrality and $\beta-$equilibrium, which are relevant for the description of the quark matter in the core of compact stellar objects. Firstly we compute the effects of the chiral crossover on the axion mass and self-coupling. We find that the low energy properties of axion are very sensitive to the phase transition of Quantum Chromodynamics, in particular, when the bulk quark matter is close to criticality. Then, for the first time in the literature we compute the axion potential at finite quark chemical potential and study the axion domain walls in bulk quark matter. We find that the energy barrier between two adjacent vacuum states decrease in the chirally restored phase: this results in a lower surface tension of the walls. Finally, we comment on the possibility of production of walls in dense quark matter.Comment: 10 pages, 7 figure

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

BackgroundPrimary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care.MethodsPragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted.Results789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95$16 to $44) per additional action met.ConclusionsA Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner

Third family of compact stars within a nonlocal chiral quark model equation of state

A class of hybrid compact star equations of state is investigated that joins by a Maxwell construction a low-density phase of hadronic matter, modeled by a relativistic mean-field approach with excluded nucleon volume, with a high-density phase of color superconducting two-flavor quark matter, described within a nonlocal covariant chiral quark model. It is found that the occurrence of a stable branch of hybrid compact stars requires a nonvanishing vector meson coupling in the quark model that exceeds a minimal value which depends on the presence of a diquark condensate. It is shown that these hybrid stars do not form a third family disconnected from the second family of ordinary neutron stars unless additional (de)confining effects are introduced with a density-dependent bag pressure. A suitably chosen density dependence of the vector meson coupling assures that at the same time the 2 M maximum mass constraint is fulfilled on the hybrid star branch. A twofold interpolation method is realized which implements both the density dependence of a confining bag pressure at the onset of the hadron-to-quark matter transition and the stiffening of quark matter at higher densities by a density-dependent vector meson coupling. For three parametrizations of this class of hybrid equation of state the properties of corresponding compact star sequences are presented, including mass twins of neutron and hybrid stars at 2.00, 1.39 and 1.20 M, respectively, and the hybrid compact star (third) families. The sensitivity of the hybrid equation of state and the corresponding compact star sequences to variations of the interpolation parameters at the 10% level is investigated and it is found that the feature of third family solutions for compact stars is robust against such a variation. This advanced description of hybrid star matter allows us to interpret GW170817 as a merger not only of two neutron stars but also of a neutron star with a hybrid star or of two hybrid stars.Fil: Alvarez Castillo, D. E.. Bogoliubov Laboratory Of Theoretical Physics; Rusia. Universidad Autónoma de San Luis Potosí; MéxicoFil: Blaschke, D. B.. Bogoliubov Laboratory For Theoretical Physics; Rusia. University Of Wroclaw; PoloniaFil: Grunfeld, Ana Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Comisión Nacional de Energía Atómica; ArgentinaFil: Pagura, V. P.. Universidad de Valencia; Españ