Patients' experiences of a suppoRted self-manAGeMent pAThway In breast Cancer (PRAGMATIC): quality of life and service use results.

PURPOSE: To describe trends and explore factors associated with quality of life (QoL) and psychological morbidity and assess breast cancer (BC) health service use over a 12-month period for patients joining the supported self-management (SSM)/patient-initiated follow-up (PIFU) pathway. METHODS: Participants completed questionnaires at baseline, 3, 6, 9 and 12 months that measured QoL (FACT-B, EQ 5D-5L), self-efficacy (GSE), psychological morbidity (GHQ-12), roles and responsibilities (PRRS) and service use (cost diary). RESULTS: 99/110 patients completed all timepoints; 32% (35/110) had received chemotherapy. The chemotherapy group had poorer QoL; FACT-B total score mean differences were 8.53 (95% CI: 3.42 to 13.64), 5.38 (95% CI: 0.17 to 10.58) and 8.00 (95% CI: 2.76 to 13.24) at 6, 9 and 12 months, respectively. The odds of psychological morbidity (GHQ12 >4) were 5.5-fold greater for those treated with chemotherapy. Financial and caring burdens (PRRS) were worse for this group (mean difference in change at 9 months 3.25 (95% CI: 0.42 to 6.07)). GSE and GHQ-12 scores impacted FACT-B total scores, indicating QoL decline for those with high baseline psychological morbidity. Chemotherapy patients or those with high psychological morbidity or were unable to carry out normal activities had the highest service costs. Over the 12 months, 68.2% participants phoned/emailed breast care nurses, and 53.3% visited a hospital breast clinician. CONCLUSION: The data suggest that chemotherapy patients and/or those with heightened psychological morbidity might benefit from closer monitoring and/or supportive interventions whilst on the SSM/PIFU pathway. Reduced access due to COVID-19 could have affected service use.

Talking about risk in the context of genomic tests (TARGET): development and evaluation of an educational program for clinicians.

PURPOSE: Gene expression profiling (GEP) test scores calculate risks of recurrence and likely benefit of adjuvant chemotherapy in ER-positive, HER2-negative, early-stage breast cancer. As health literacy and numeracy skills in the general population are poor, healthcare professionals (HCPs) require a wide repertoire of communication skills to explain clearly risk of recurrence scores (RSs) and uncertainty. We developed and evaluated an educational program for HCPs discussing GEP test results and adjuvant treatment. METHODS: Eight-hour workshops contained elements aimed at improving knowledge, communication skills and self-awareness; these included the science underpinning GEP tests, an interactive risk psychology lecture, exercises and facilitated group discussions regarding seven filmed scenarios involving discussions about high, intermediate and low RSs. Attendees were recorded explaining RSs with patient simulators pre and post workshop. Researchers, blinded to time point, analysed recordings using a study-specific scoring system. Primary objective outcomes were improvements post workshop in HCPs' competence and confidence when communicating 17 pre-specified key information areas. We estimated odds ratios (OR) using conditional logistic regression to compare pre- and post-workshop scores. RESULTS: 65 HCPs attended. Objective analyses revealed significant positive shifts post workshop which included explaining GEP tests (OR 2.98; 95% CI 1.38-6.42; P = .001), recurrence RSs (OR 3.99; 95% CI 1.72-9.25; P < .001), benefits of chemotherapy (OR 3.99; 95% CI 1.82-8.75; P < .001; and harms OR 2.31; 95% CI 1.37-3.92; P < .001) using jargon free language (OR 5.29; 95% CI 2.27-12.35; P < .001). Patient simulator assessments also showed significant improvements as did HCPs' self-assessments and ratings of their self-confidence when discussing different GEP tests with diverse patient types (P < .001). CONCLUSION: These short, intensive, interactive TARGET workshops significantly improved HCPs' communication about GEP results in ways likely to promote more informed decision-making by patients about chemotherapy.

Patients' and oncologists' views on the treatment and care of advanced ovarian cancer in the U.K.: results from the ADVOCATE study.

BACKGROUND: Most patients presenting with advanced ovarian cancer (AOC) eventually relapse. Symptom palliation, maintenance of quality of life (QoL) and prolongation of life are primary therapeutic goals. METHODS: Sixty-six U.K. oncologists completed an online survey about AOC management. Two hundred and two patients were interviewed about care, treatment experiences and expectations. RESULTS: Prior to diagnosis, 34% (69 out of 202) of women had > or =3 symptoms associated with AOC. Twenty-one per cent (43 out of 202) thought poor symptom recognition by general practitioners (GPs) delayed diagnosis. Amelioration of side effects experienced was variable, for example, only 54% (68 out of 127) distressed by alopecia had received sufficient information about it. Clinicians were asked 'What minimum gain in progression-free survival (PFS) would make you feel it worthwhile to offer maintenance therapy?'; 48% (24 out of 50) indicated 5-6 months, but 52% (26 out of 50) believed patients would find PFS of 3-4 months acceptable. When patients were presented with hypothetical scenarios, 33% (52 out of 160) would require 1-2 months extra life, 6% (10 out of 160) 3-4 months, 31% (49 out of 160) 5-6 months, and 31% (49 out of 160) > or =7 months. However, 86% (173 out of 202) would accept treatment that improved QoL without prolongation of life. When asked what was most important, 33% (67 out of 201) said QoL, 9% (19 out of 201) length of life and 57% (115 out of 201) said both were equally important. CONCLUSION: Clinicians' and patients' experiences, expectations and priorities about OC management may differ.

ARIX: a randomised trial of acupuncture v oral care sessions in patients with chronic xerostomia following treatment of head and neck cancer.

BACKGROUND: Radiation treatment of head and neck cancer can cause chronic xerostomia which impairs patients' quality of life. The study reported here examined the efficacy of acupuncture in alleviating xerostomia symptoms especially dry mouth. PATIENTS AND METHODS: A total of 145 patients with chronic radiation-induced xerostomia >18 months after treatments were recruited from seven UK cancer centres. The study employed a randomised crossover design with participants receiving two group sessions of oral care education and eight of acupuncture using standardised methods. Patient-reported outcome (PROs) measures were completed at baseline and weeks 5, 9, 13, 17, and 21. The primary outcome was improvement in dry mouth. OBJECTIVE: saliva measurements were also carried out. RESULTS: Acupuncture compared with oral care, produced significant reductions in patient reports of severe dry mouth (OR = 2.01, P = 0.031) sticky saliva (OR = 1.67, P = 0.048), needing to sip fluids to swallow food (OR = 2.08, P = 0.011) and in waking up at night to drink (OR = 1.71, P = 0.013). There were no significant changes in either stimulated or unstimulated saliva measurements over time. CONCLUSION: Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia.

Are childhood factors predictive of adult health literacy? A longitudinal birth cohort analysis.

Health literacy (HL), defined as the ability of an individual to understand and appraise health information to make informed decisions on their health, helps maintain and improve one's health and thus reduce the use of healthcare services. There is a recognised global effort to address insufficient HL in early life and understand how HL develops. This study examined the association of a range of factors including educational, speech and language ability, health and healthcare engagement, sleep problems, mental health, demographic, environmental, and maternal factors at different childhood stages (from 5 years to 11 years) with later adult HL at age 25. HL was measured using a HL ordinal score (insufficient, limited, or sufficient) derived from the European Literacy Survey Questionnaire-short version (HLS-EU-Q16) within a large UK based birth cohort (Avon Longitudinal Study of Parents and Children: ALSPAC study). Univariate proportional odds logistic regression models for the probability of having higher levels of HL were developed. Results of analysis of 4248 participants showed that poorer speech and language ability (aged 9 years, OR 0.18 95% CI 0.04 to 0.78), internalising in child (age 11 years, OR 0.62 95% CI 0.5 to 0.78), child depression (age 9 years, OR 0.67 95% CI 0.52 to 0.86), and the presence of maternal depression (child age 5, OR 0.80 95% CI 0.66 to 0.96), reduced the odds of sufficient HL when adult. Our results suggest some useful markers to identify children at potential risk of low HL that could be targeted for research into future interventions within school settings, for example, child's speech and language capability. In addition, this study identified child and maternal mental health as factors associated with later development of limited HL and future research should consider what potential mechanisms might explain this link.

Treatment Experiences, Information Needs, Pain and Quality of Life in Men with Metastatic Castrate-resistant Prostate Cancer: Results from the EXTREQOL Study.

AIMS: Delaying progression, ameliorating symptoms and maintaining quality of life (QoL) are primary aims of treatment for metastatic castrate-resistant prostate cancer (mCRPC). Real-world rather than clinical trial data about symptoms and side-effects are sparse. In EXTREQOL, patients' QoL, pain and information needs were recorded during treatment. MATERIAL AND METHODS: Men with mCRPC from 20 UK cancer centres starting various systemic mCRPC treatments completed QoL, pain and information needs questionnaires at baseline, 3 and 6 months. RESULTS: In total, 132 patients were recruited. Overall QoL declined significantly by 6 months (Functional Assessment of Cancer Therapy-Prostate [FACT-P] mean = -3.89, 95% confidence interval -6.7 to -1.05, P = 0.007; Trial Outcome Index [TOI] analysis mean = -3.10, 95% confidence interval -5.34 to -0.83, P = 0.007). Those who came off novel therapy and remained on luteinising hormone-releasing hormone agonist therapy alone had worse scores than patients receiving concomitant chemotherapy (Prostate Concerns Subscale mean difference = -4.45, 95% confidence interval -7.06 to -1.83, P = 0.001; TOI mean difference = -5.62, 95% confidence interval -10.97 to -0.26, P = 0.040). At 3 and 6 months, men who reported pain at baseline improved (43%, 40%), but for others pain levels remained the same (45%, 42%) or worsened (13%, 18%). Information regarding supportive care was lacking throughout the period of time on the study. CONCLUSION: Most mCRPC treated patients experience reduced QoL and inadequate pain control. More help with pain management and better information provision regarding supportive care is warranted.

Dynamic modelling in a study of surgical error management.

We demonstrate the use of dynamic longitudinal models to investigate error management in cardiac surgery. Case study data were collected from a multicentre study of the neonatal arterial switch operation (ASO). Information on two types of negative events, or 'errors', observed during surgery, major and minor events, was extracted from case studies. Each event was judged to be recovered from (compensated) or not (uncompensated). The aim of the study was to model compensation given the occurrence of past events within a case. Two models were developed, one for the probability of compensating for a major event and a second model for the probability of compensating for a minor event. Analyses based on dynamic logistic regression models suggest that the total number of preceding minor events, irrespective of compensation status, is negatively related with the ability to compensate for major events. The alternative use of random effects models is investigated for comparison purposes.

Regression analysis of overdispersed correlated count data with subject specific covariates.

A robust likelihood approach for the analysis of overdispersed correlated count data that takes into account cluster varying covariates is proposed. We emphasise two characteristics of the proposed method: That the correlation structure satisfies the constraints on the second moments and that the estimation of the correlation structure guarantees consistent estimates of the regression coefficients. In addition we extend the mean specification to include within- and between-cluster effects. The method is illustrated through the analysis of data from two studies. In the first study, cross-sectional count data from a randomised controlled trial are analysed to evaluate the efficacy of a communication skills training programme. The second study involves longitudinal count data which represent counts of damaged hand joints in patients with psoriatic arthritis. Motivated by this study, we generalize our model to accommodate for a subpopulation of patients who are not susceptible to the development of damaged hand joints.

Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme.

OBJECTIVE: To evaluate a training intervention aimed at improving healthcare professionals' communication with cancer patients about randomised clinical trials. DESIGN: Before and after evaluation of training programme. SETTING: Members of the National Cancer Research Network, Scottish Trials Network, and the Welsh Cancer Trials Network. PARTICIPANTS: 101 healthcare professionals (33 clinicians and 68 research nurses). INTERVENTION: Four modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing randomised clinical trials with patients, problems specific to adjuvant trials, trials with palliation as the goal, and trials where patients had a strong preference for one treatment arm. MAIN OUTCOME MEASURES: Before and after the intervention, participants were videotaped discussing a trial with an actor portraying a patient. These consultations were assessed for presence of information required by good clinical practice guidelines. The actor patients gave an assessment after each interview. Participants reported their self confidence about key aspects of trial discussion. RESULTS: Analysis of the videotaped consultations showed that, after intervention, significantly more participants displayed key communication behaviours such as explaining randomisation (69 v 81, odds ratio 2.33, P = 0.033), checking patients' understanding (11 v 31, odds ratio 3.22, P = 0.002), and discussing standard treatment (73 v 88, odds ratio 4.75, P = 0.005) and side effects (69 v 85, odds ratio 3.29, P = 0.006). Participants' self confidence increased significantly (P < 0.001) across all areas. Actor patients' ratings of participants' communication showed significant improvements for 12/15 key items. CONCLUSION: This intensive 8 hour intervention significantly improved participants' confidence and competence when communicating about randomised clinical trials.

Enduring impact of communication skills training: results of a 12-month follow-up.

The efficacy of a communication skills training programme was shown through a randomised trial. Oncologists (N=160) from 34 cancer centres were allocated to written feedback plus course; course alone; written feedback alone or control. Each clinician had 6 - 10 interviews with patients videotaped at baseline and 3 months postintervention. Analysis of videotapes revealed improvements in the communication skills of clinicians randomised to training (n=80) compared with others (n=80). A 12-month follow-up assessment is reported here. Robust Poisson conditional analyses of counts of changes in communication behaviours revealed no demonstrable attrition in those who had shown improvement previously, including fewer leading questions, appropriate use of focused and open-ended questions and responses to patient cues. Additional skills, not apparent at 3 months, were now evident; the estimated effect sizes corresponded to 81% fewer interruptions (P=0.001) and increased summarising of information to 38% (P=0.038). However, expressions of empathy (54%, P=0.001) declined. The overall results show that 12 - 15 months postintervention, clinicians had integrated key communication skills into clinical practice and were applying others. This is the first RCT to show an enduring effect of communication skills training with transfer into the clinic.