Anne Lanceley

Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial

Summary Background In the Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms 7 (ICON7) trial, bevacizumab improved progression-free survival in patients with ovarian cancer when used in combination with first-line chemotherapy and as a single-drug continuation treatment for 18 cycles. In a preliminary analysis of a high-risk subset of patients, there was also an improvement in overall survival. This study aims to describe the health-related quality-of-life (QoL) outcomes from ICON7. Methods ICON7 is a randomised, multicentre, open-label phase 3 trial. Between Dec 18, 2006, and Feb 16, 2009, after a surgical procedure aiming to debulk the disease, women with International Federation of Gynecology and Obstetrics (FIGO) high-risk stage I–IV epithelial ovarian cancer were randomly allocated (1:1) by computer program and block randomisation to receive either six cycles of standard chemotherapy (total 18 weeks) with carboplatin (area under the curve 5 or 6) and paclitaxel (175 mg/m2) alone or with bevacizumab (7·5 mg/kg) given intravenously with chemotherapy and continued as a single drug thereafter (total 54 weeks). The primary QoL endpoint was global QoL from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire–core 30 at week 54, analysed by ANOVA and adjusted for baseline score. Analyses were by intention to treat. The ICON7 trial has completed recruitment and remains in follow-up. This study is registered, number ISRCTN91273375. Findings 764 women were randomly assigned to the standard chemotherapy group and 764 to the bevacizumab group. At baseline, 684 (90%) of women in the standard chemotherapy group and 691 (90%) of those in the bevacizumab group had completed QoL questionnaires. At week 54, 502 (66%) women in the bevacizumab group and 388 (51%) women in the standard chemotherapy group provided QoL data. Overall, the mean global QoL score improved during chemotherapy by 7·2 points (SD 24·4) when analysed for all women with data at baseline and week 18. The mean global QoL score at 54 weeks was higher in the standard chemotherapy group than in the bevacizumab group (76·1 [SD 18·2] vs 69·7 [19·1] points; difference 6·4 points, 95% CI 3·7–9·0, p<0·0001). Interpretation Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions. Funding Roche and the National Institute for Health Research through the UK National Cancer Research Network.

Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, body mass index, hysterectomy, hormone therapy use, lifestyle and mood in a cross‐sectional cohort study of 10 418 British women aged 54–65

Please cite this paper as: Hunter M, Gentry‐Maharaj A, Ryan A, Burnell M, Lanceley A, Fraser L, Jacobs I, Menon U. Prevalence, frequency and problem rating of hot flushes persist in older postmenopausal women: impact of age, body mass index, hysterectomy, hormone therapy use, lifestyle and mood in a cross‐sectional cohort study of 10 418 British women aged 54–65. BJOG 2012;119:40–50.

Development of an EORTC quality of life phase III module measuring cancer‐related fatigue (EORTC QLQ‐FA13)

European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer‐related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ‐C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients.

Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

AIM A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. METHODS Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. RESULTS Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbachs alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). CONCLUSION The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials.

Family history and women with ovarian cancer: is it asked and does it matter?: An observational study.

Objective The objective of the study was to determine how many women in an ovarian cancer (OC) study cohort had a family history (FH) recorded in their case notes and whether appropriate action was taken on the basis of that FH. Methods This was a review of patient case-note data of women in a randomized controlled trial of follow-up after primary treatment for OC. Available case notes of 114 women recruited at 3 UK gynecologic cancer centers in a 2-year period between January 2006 and 2008 were examined. Case-note entries for the period from first hospital consultation to 2 years after completion of primary treatment were included. Outcome measures were (1) recording of an FH of cancer in the case notes, (2) whether appropriate action had been taken on the basis of the FH in those women with affected relatives, and (3) characterizing insufficient FH records. Results Family history was not consistently recorded. Although FH was recorded in the majority of women, 14 women had no FH recorded. In 63 women, the FH was recorded as not significant, and in 15 cases, FH information was insufficient to complete a risk assessment. Twenty-two women had significant FH meeting criteria for specialist genetics referral. In 15 of these 22 cases, the relevant history suggestive of hereditary breast cancer and OC (due to BRCA1 or BRCA2 mutations) or Lynch syndrome had been documented, but no action was recorded, and its significance was not appreciated. Conclusions These data indicate that training in recognizing relevant FH is needed for clinicians looking after women with OC. Research is necessary to determine the barriers in taking and interpreting an FH and to determine the optimal time for broaching FH issues during a woman’s care pathway. This will improve the accuracy of FH recording and ensure families with OC have access to appropriate surveillance and genetic testing.

Investigating the therapeutic potential of a heritage-object focused intervention: a qualitative study

This study explores the therapeutic potential of heritage-object handling in nurse-patient encounters with women facing cancer. Ten women participated in an object-focused conversation with a nurse specialist. Sessions were audio-tape recorded and transcribed. Kleinian theory framed the analysis to reveal the individual ways women ‘used’ the object in the session. Professionally observed heritage-object handling provides an aid to discussion with patients and has potential as an assessment platform for therapeutic work or as an intervention approach in its own right. Further longitudinal controlled trials are needed to evaluate such benefits, particularly given the depth of the talk revealed in this study.

Determinants of treatment plan implementation in multidisciplinary team meetings for patients with chronic diseases: a mixed-methods study

Objective Multidisciplinary team (MDT) meetings are assumed to produce better decisions and are extensively used to manage chronic disease in the National Health Service (NHS). However, evidence for their effectiveness is mixed. Our objective was to investigate determinants of MDT effectiveness by examining factors influencing the implementation of MDT treatment plans. This is a proxy measure of effectiveness, because it lies on the pathway to improvements in health, and reflects team decision making which has taken account of clinical and non-clinical information. Additionally, this measure can be compared across MDTs for different conditions. Methods We undertook a prospective mixed-methods study of 12 MDTs in London and North Thames. Data were collected by observation of 370 MDT meetings, interviews with 53 MDT members, and from 2654 patient medical records. We examined the influence of patient-related factors (disease, age, sex, deprivation, whether their preferences and other clinical/health behaviours were mentioned) and MDT features (as measured using the ‘Team Climate Inventory’ and skill mix) on the implementation of MDT treatment plans. Results The adjusted odds (or likelihood) of implementation was reduced by 25% for each additional professional group represented at the MDT meeting. Implementation was more likely in MDTs with clear goals and processes and a good ‘Team Climate’ (adjusted OR 1.96; 95% CI 1.15 to 3.31 for a unit increase in Team Climate Inventory (TCI) score). Implementation varied by disease category, with the lowest adjusted odds of implementation in mental health teams. Implementation was also lower for patients living in more deprived areas (adjusted odds of implementation for patients in the most compared with least deprived areas was 0.60, 95% CI 0.39 to 0.91). Conclusions Greater multidisciplinarity is not necessarily associated with more effective decision making. Explicit goals and procedures are also crucial. Decision implementation should be routinely monitored to ensure the equitable provision of care.

Use and perceived efficacy of complementary and alternative medicines after discontinuation of hormone therapy: a nested United Kingdom Collaborative Trial of Ovarian Cancer Screening cohort study

ObjectiveGiven that the Women’s Health Initiative reported in 2002 increased risks of breast cancer and cardiovascular events with hormone therapy (HT) use and many women discontinued use, we assessed the use and perceived efficacy of complementary and alternative medicines (CAMs) for menopausal symptom relief after discontinuation of HT. MethodsPostmenopausal women aged 50 to 65 years within the United Kingdom Collaborative Trial of Ovarian Cancer Screening who were willing to take part in a secondary study were mailed a survey to evaluate menopausal symptom management. Use and perceived efficacy of CAMs for relief of vasomotor symptoms (VMS) upon discontinuation of HT were examined. ResultsThe survey was sent to 15,000 women between July 2 and July 9, 2008. Seventy-one percent (10,662 of 15,000) responded, and 10,607 women with complete data were included. Ever use of HT was reported by 60.2% (6,383 of 10,607). At survey completion, 79.3% (5,060 of 6,383) had discontinued HT, with 89.7% (4,540 of 5,060) of the latter reporting using one or more CAMs for VMS relief. About 70.4% (3,561 of 5,060) used herbal remedies, with evening primrose oil (48.6%; 2,205 of 4,540) and black cohosh (30.3%;1,377 of 4,540) being most commonly used. Exercise was used by 68.2% (3,098 of 4,540), whereas other behavioral/lifestyle approaches were less frequently reported (13.9%; 629 of 4,540). Contrarily, more women (57%-72%) rated behavioral/lifestyle approaches as effective compared with herbal remedies (28%-46%; rating ≥4 on a “helpfulness” scale from 1-10). Among medical treatments, selective serotonin reuptake inhibitors were used by 10% and rated effective by 72.1%. ConclusionsAlthough more women use over-the-counter medicines, behavioral/lifestyle approaches seem to provide better relief of VMS. There is a pressing need for better evidence-based lay information to support decision-making on CAM use for relief of VMS.

Heritage, health and well-being: assessing the impact of a heritage focused intervention on health and well-being

Do museums and other heritage organisations have something to offer the healthcare sector? Do they have a role in improving health and well-being? Increasingly both heritage and healthcare organisations think they do. A broader definition of health including well-being and an emphasis on preventative medicine and multi-agency approaches to care within the UK’s National Health Service has facilitated the work of museums and galleries in this area. However, there are still few specific heritage programmes in healthcare organisations and very little evaluation of these. Here we present key findings from a qualitative evaluation of a heritage focused intervention carried out in a range of healthcare settings. The aim of the research project was to assess the impact on well-being of taking museum objects into hospitals and healthcare contexts.

Quantitative evidence for wellbeing benefits from a heritage-in-health intervention with hospital patients

Abstract The benefits of a heritage-in-health intervention were assessed using clinically accepted psychometric measures of wellbeing and happiness. Positive outcomes of arts-in-health activities are well documented and reviewed yet little empirical research has been conducted to determine the effectiveness of heritage-in-health activities. The research drew upon art therapy, psychology and education for a conceptual framework. General healthcare patients participated in one-to-one, facilitated sessions of around 40 minutes that involved discussing factual and emotional properties of a selection of museum objects. Questions followed a standardised protocol with a semi-structured interview format. In the experimental group, participants handled the objects (tactile condition) whereas in the comparison group, participants looked at pictures of these objects (visual condition). Baseline and intervention self-report measures (Positive Affect Negative Affect Scale and Visual Analogue Scales) were used to evaluate the sessions. Quantitative comparison of pre- and post-session scores showed significant increases in wellbeing and happiness and an advantage for the tactile condition over the visual condition. Museum object handling sessions appeared to produce therapeutic effects on patient welfare, at least in the short term. Findings add weight to the need for provision of heritage-focused activities by museums and galleries for excluded audiences in healthcare settings.