A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol

<p>Abstract</p> <p>Background</p> <p>This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats) in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested:</p> <p>Compared to usual care, group cognitive behavioural therapy will:</p> <p>1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation.</p> <p>2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation.</p> <p>Methods/Design</p> <p>Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT) sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes.</p> <p>Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires) are collected six to eight weeks later and follow-up measures (questionnaires and a use of medical services measure) at six months post-randomisation.</p> <p>Discussion</p> <p>MENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals.</p> <p>Trial Registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN13771934">ISRCTN13771934</a></p

Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study.

BACKGROUND: Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices. METHODS: 417 men and women aged 40-69 recruited from town centres in the UK were randomised to receive either an invitation for diabetes screening designed to facilitate informed choice or a standard type of invitation. Knowledge of the invitation, attitude towards diabetes screening, and intention to attend for diabetes screening were assessed two weeks later. RESULTS: Attitude was a strong predictor of screening intentions (β = .64, p = .001). Knowledge added to the model but was a weak predictor of intentions (β = .13, p = .005). However, invitation type did not predict attitudes towards screening but did predict knowledge (β = -.45, p = .001), which mediated a small effect of invitation type on intention (indirect β = -.06, p = .017). CONCLUSIONS: These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

The Importance of Microhabitat for Biodiversity Sampling

Peer reviewe

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol.

BACKGROUND: Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation. METHOD/DESIGN: 1500 people aged 40-69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in attendance between arms, and in an estimated 780 attenders, 80% power to detect a 0.2 sd difference in intention between arms. DISCUSSION: The DICISION trial is a rigorous pragmatic denominator based clinical trial of an informed choice invitation to diabetes screening, which addresses some key limitations of previous trials.RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial

Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action

Physiographic Controls on Landfast Ice Variability from 20 Years of Maximum Extents across the Northwest Canadian Arctic

Landfast ice is a defining feature among Arctic coasts, providing a critical transport route for communities and exerting control over the exposure of Arctic coasts to marine erosion processes. Despite its significance, there remains a paucity of data on the spatial variability of landfast ice and limited understanding of the environmental processes’ controls since the beginning of the 21st century. We present a new high spatiotemporal record (2000–2019) across the Northwest Canadian Arctic, using MODIS Terra satellite imagery to determine maximum landfast ice extent (MLIE) at the start of each melt season. Average MLIE across the Northwest Canadian Arctic declined by 73% in a direct comparison between the first and last year of the study period, but this was highly variable across regional to community scales, ranging from 14% around North Banks Island to 81% in the Amundsen Gulf. The variability was largely a reflection of 5–8-year cycles between landfast ice rich and poor periods with no discernible trend in MLIE. Interannual variability over the 20-year record of MLIE extent was more constrained across open, relatively uniform, and shallower sloping coastlines such as West Banks Island, in contrast with a more varied pattern across the numerous bays, headlands, and straits enclosed within the deep Amundsen Gulf. Static physiographic controls (namely, topography and bathymetry) were found to influence MLIE change across regional sites, but no association was found with dynamic environmental controls (storm duration, mean air temperature, and freezing and thawing degree day occurrence). For example, despite an exponential increase in storm duration from 2014 to 2019 (from 30 h to 140 h or a 350% increase) across the Mackenzie Delta, MLIE extents remained relatively consistent. Mean air temperatures and freezing and thawing degree day occurrences (over 1, 3, and 12-month periods) also reflected progressive northwards warming influences over the last two decades, but none showed a statistically significant relationship with MLIE interannual variability. These results indicate inferences of landfast ice variations commonly taken from wider sea ice trends may misrepresent more complex and variable sensitivity to process controls. The influences of different physiographic coastal settings need to be considered at process level scales to adequately account for community impacts and decision making or coastal erosion exposure

Breast MRI: EUSOBI recommendations for women's information.

UNLABELLED: This paper summarizes information about breast MRI to be provided to women and referring physicians. After listing contraindications, procedure details are described, stressing the need for correct scheduling and not moving during the examination. The structured report including BI-RADS® categories and further actions after a breast MRI examination are discussed. Breast MRI is a very sensitive modality, significantly improving screening in high-risk women. It also has a role in clinical diagnosis, problem solving, and staging, impacting on patient management. However, it is not a perfect test, and occasionally breast cancers can be missed. Therefore, clinical and other imaging findings (from mammography/ultrasound) should also be considered. Conversely, MRI may detect lesions not visible on other imaging modalities turning out to be benign (false positives). These risks should be discussed with women before a breast MRI is requested/performed. Because breast MRI drawbacks depend upon the indication for the examination, basic information for the most important breast MRI indications is presented. Seventeen notes and five frequently asked questions formulated for use as direct communication to women are provided. The text was reviewed by Europa Donna-The European Breast Cancer Coalition to ensure that it can be easily understood by women undergoing MRI. KEY POINTS: • Information on breast MRI concerns advantages/disadvantages and preparation to the examination • Claustrophobia, implantable devices, allergic predisposition, and renal function should be checked • Before menopause, scheduling on day 7-14 of the cycle is preferred • During the examination, it is highly important that the patient keeps still • Availability of prior examinations improves accuracy of breast MRI interpretation.This is the final version of the article. It first appeared from Springer via http://dx.doi.org/10.1007/s00330-015-3807-

Breast ultrasound: recommendations for information to women and referring physicians by the European Society of Breast Imaging

Abstract This article summarises the information that should be provided to women and referring physicians about breast ultrasound (US). After explaining the physical principles, technical procedure and safety of US, information is given about its ability to make a correct diagnosis, depending on the setting in which it is applied. The following definite indications for breast US in female subjects are proposed: palpable lump; axillary adenopathy; first diagnostic approach for clinical abnormalities under 40 and in pregnant or lactating women; suspicious abnormalities at mammography or magnetic resonance imaging (MRI); suspicious nipple discharge; recent nipple inversion; skin retraction; breast inflammation; abnormalities in the area of the surgical scar after breast conserving surgery or mastectomy; abnormalities in the presence of breast implants; screening high-risk women, especially when MRI is not performed; loco-regional staging of a known breast cancer, when MRI is not performed; guidance for percutaneous interventions (needle biopsy, pre-surgical localisation, fluid collection drainage); monitoring patients with breast cancer receiving neo-adjuvant therapy, when MRI is not performed. Possible indications such as supplemental screening after mammography for women aged 40–74 with dense breasts are also listed. Moreover, inappropriate indications include screening for breast cancer as a stand-alone alternative to mammography. The structure and organisation of the breast US report and of classification systems such as the BI-RADS and consequent management recommendations are illustrated. Information about additional or new US technologies (colour-Doppler, elastography, and automated whole breast US) is also provided. Finally, five frequently asked questions are answered. Teaching Points • US is an established tool for suspected cancers at all ages and also the method of choice under 40. • For US-visible suspicious lesions, US-guided biopsy is preferred, even for palpable findings. • High-risk women can be screened with US, especially when MRI cannot be performed. • Supplemental US increases cancer detection but also false positives, biopsy rate and follow-up exams. • Breast US is inappropriate as a stand-alone screening method