In the North Thames Mainstreaming of Breast Cancer Genetic Testing (NT-MBGT) programme, we piloted testing for breast cancer susceptibility genes (BCSGs) in unselected breast cancer (BC) patients, deploying a clinician-light ‘BRCA-DIRECT’ mainstreaming pathway; this included home saliva-testing and consent with postal return, written and digital materials, with full access to a Genetic Counsellor Telephone helpline. Across 14 National Health Service (NHS) breast oncology units, we successfully tested 3515 newly-diagnosed BC patients with high levels of patient and breast healthcare professional (HCP) satisfaction and genetics HCPs reporting decreases in service referrals. The pick-up rate of gPVs was 4.7% (166 germline Pathogenic Variants (gPVs) across seven BCSGs). Examining application of current NHS eligibility criteria to the unselected cohort, testing would have been offered to 20.6% of patients with identification of 49.2% of gPVs in high penetrance (HP)-BCSGs (BRCA1/BRCA2/PALB2) and 18.2% of gPVs in intermediate penetrance-BCSGs (CHEK2/ATM/RAD51C/RAD51D). Designing ‘Ultra-simple’ eligibility criteria suitable for mainstreaming, detection (sensitivity) could be improved to 81.1% and 70.4% respectively, whilst increasing testing to 49.7% of BC cases. Evidence from the NT-MBGT programme demonstrates that expanding BCSG-testing via a clinician-light pathway is acceptable and feasible, without increasing the burden on limited breast and genetics workforce, and has high satisfaction.

BACKGROUND:Scientific advancements have increased the use of biomarker testing for metastatic breast cancer (mBC) treatment decisions, adding complexity which may impact patient understanding. This study assesses patient recall and understanding of biomarker information and barriers to understanding diagnosis. MATERIALS AND METHODS:An online, multi-language, 15-question multiple choice survey was distributed to people with a self-reported diagnosis of mBC through the Advanced Breast Cancer (ABC) Global Alliance. Data collected included patient demographics, disease history, information seeking behaviour, and barriers to learning about their breast cancer subtype. RESULTS:Across 36 countries, 1064 respondents completed the survey. 81% recognised that their breast cancer subtype influences treatment decisions, though there was wide variation in patient recall of terminology used by their healthcare professionals (HCPs). Recall of the term 'biomarker' was low (8%). Geographical differences existed in patient recall of specific biomarkers used to describe mBC diagnosis; 'hormone receptor-positive (HR+)' recall was significantly higher for patients from North America (73%), compared with other regions (14%-56%). One-third (33%) of patients did not understand their breast cancer subtype and what it means. Only 44% of patients felt HCPs had given them sufficient information about their breast cancer subtype. A subset of patients (7%) reported not wanting to learn more, with the highest proportion from Latin America (17%). CONCLUSIONS:Findings demonstrate limited patient recall and understanding of breast cancer biomarkers and subtype, with significant variation based on geography. Results may be used to improve two-way communication and patient understanding regarding biomarker status, to facilitate shared decision-making.

Aims: This study explored perceptions and initial experiences of abemaciclib, a CDK4/6 inhibitor, plus endocrine therapy (ET) as adjuvant targeted therapy for early breast cancer with high risk of recurrence (EBC). Early onset diarrhea is the most common side-effect, but its impact is often under-recognized and may affect treatment adherence. Methods: Three serial interviews were conducted with five women with EBC recruited from four UK breast units. The baseline interview took place before the start of treatment, follow-up interviews 4 and 8 weeks later. Transcripts were analyzed following the framework approach to thematic analysis. Results: Diarrhea at follow-up was reported by 4 women, and in 3 this was the most bothersome symptom. It was usually managed by anti-diarrheal drugs and/or dietary modifications. One woman discontinued treatment due to its effect on day-to-day living. All patients said they adhered to treatment. Beliefs that the drug offered a lower risk of recurrence helped some to tolerate side-effects, alongside support from their clinical teams. Conclusion: These initial findings showed that abemaciclib plus ET was generally manageable. Regular follow-up in this patient cohort could support early detection of symptoms. Further longitudinal real-world research into patients' experiences with abemaciclib plus ET for EBC is warranted. Trial registration: NCT04584853 (06/07/2020)

Significant healthcare disparities can be experienced by d/Deaf individuals, particularly in accessing effective communication and health information. Limited research has examined the experiences of d/Deaf cancer patients or how their interactions with healthcare professionals (HCPs) and communication support professionals (CSPs) influence their quality of care. This scoping review aimed to map current evidence about the communication and unmet needs of d/Deaf cancer patients, educational needs of HCPs and roles of CSPs. Following the Joanna Briggs Institute method for Scoping Reviews, database searches were conducted on PsycInfo, PubMed, Embase, CINAHL and Scopus, and grey literature was identified. Papers published in English that reported on the experiences of d/Deaf cancer patients and their communication with HCPs and CSPs were included. Thematic analysis was used to identify key descriptive themes. Only nine (1 quantitative, 7 qualitative, 1 mixed-methods) papers were included. Most focused on d/Deaf cancer patients (mainly breast cancer); only 1 included HCPs and none examined CSPs. Three main themes and 9 subthemes were identified that negatively impacted d/Deaf cancer patients’ views about their healthcare: system-level factors; interpersonal factors and patient-level factors. The HCP-focused paper highlighted that collaboration with interpreting services enhanced communication and patient understanding. Despite limited data, this review highlights multiple barriers d/Deaf patients can encounter when accessing cancer services. Collectively, these may affect effective communication practices and can compromise the quality of care delivered. Data supports accessible educational resources, improved access to qualified medical interpreters and deaf awareness training for HCPs.

Objective Explaining gene expression profiling (GEP) test results to patients can be challenging. We examined the utility of two 8 min films about Oncotype DX and Prosigna to aid the knowledge and decision-making of women with early-stage oestrogen receptor positive (ER+) breast cancer. Methods and analysis Patients awaiting GEP test results completed an anxiety questionnaire and the intolerance of uncertainty scale (IUS) before randomisation and divided into Group A (standard verbal and/or written hospital information) or Group B (standard information plus GEP film). Prior to results, they were interviewed about their GEP test knowledge and how the recurrence risk helps determine treatment options. After the results consultation, participants answered two further questionnaires. Participating clinicians completed IUS scales and reported their satisfaction with the results discussions. Results 230/251 patients completed the study (Group A (n=106) and Group B (n=124)). The total knowledge score was higher in Group B (estimated between groups mean difference of 2.5 (95% CI:1.7 to 3.4) p<0.001). Most treatment decisions adhered to recommended risk of recurrence thresholds, although patients with higher trait anxiety were more likely to make less apparently rational decisions OR=0.93 (95%CI 0.88 to 0.97) p=0.002 (163/230; 70.8% received ET alone; 65/230; 28% ET plus chemotherapy, and two sought second opinions). Clinicians reported slightly longer consultations for Group A participants who tended to ask more difficult and unexpected questions. Conclusion Patients who received standard verbal and written information plus film had increased knowledge about GEP tests compared with standard information alone. Trial registration number ISRCTN28497350 .

This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 16/46/01, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1186/s13063-021-05125-8 During trials that span decades, new evidence including progress in statistical methodology, may require revision of original assumptions. An example is the continued use of a constant-effect approach to analyse the mortality reduction which is often delayed in cancer-screening trials. The latter led us to re-examine our approach for the upcoming primary mortality analysis (2020) of long-term follow-up of the United Kingdom Collaborative Trial of Ovarian Cancer Screening (LTFU UKCTOCS), having initially (2014) used the proportional hazards (PH) Cox model. We wrote to 12 experts in statistics/epidemiology/screening trials, setting out current evidence, the importance of pre-specification, our previous mortality analysis (2014) and three possible choices for the follow-up analysis (2020) of the mortality outcome: (A) all data (2001–2020) using the Cox model (2014), (B) new data (2015–2020) only and (C) all data (2001–2020) using a test that allows for delayed effects. Of 11 respondents, eight supported changing the 2014 approach to allow for a potential delayed effect (option C), suggesting various tests while three favoured retaining the Cox model (option A). Consequently, we opted for the Versatile test introduced in 2016 which maintains good power for early, constant or delayed effects. We retained the Royston-Parmar model to estimate absolute differences in disease-specific mortality at 5, 10, 15 and 18 years. The decision to alter the follow-up analysis for the primary outcome on the basis of new evidence and using new statistical methodology for long-term follow-up is novel and has implications beyond UKCTOCS. There is an urgent need for consensus building on how best to design, test, estimate and report mortality outcomes from long-term randomised cancer screening trials. This publication was funded by the Health Technology Assessment programme as a part of award number 16/46/01. This article reports on one component of the research award Long term impact of screening on ovarian cancer mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/16/46/01] https://doi.org/10.1186/s13063-021-05125-8

Background A study within a trial (SWAT) can be used to compare the effectiveness of various recruitment aids. In this SWAT, we assessed the impact of incorporating a pictorial aid into an enhanced Patient Information Leaflet (PIL) versus utilising a standard PIL, nested within a trial comparing adjuvant therapy alone with adjuvant therapy plus axillary treatment for women with early-stage breast cancer with metastases in one or two sentinel nodes (the POSNOC trial). Methods The pictorial aid was designed to illustrate the treatment procedures in both arms of the POSNOC trial for potential participants. POSNOC recruiting sites were cluster randomised to provide potentially eligible women who were approached about taking part in the study with either the enhanced PIL or the standard PIL. Allocation was stratified by recruitment activity in the 12 months preceding the SWAT. Results Eighty sites participated in the SWAT, with 40 randomised to each arm. Between December 2019 and July 2021, 258 participants were recruited. The enhanced PIL group recruited 117 participants (mean = 2.9 per site) while the standard PIL sites recruited 141 participants (mean = 3.5 per site). There was no evidence of a between-group difference in recruitment (adjusted difference in mean in enhanced vs standard PIL = -0.68, 95% CI -1.99 to 0.63, p=0.31). Conclusion The study found no evidence that an enhanced PIL increased recruitment compared with the standard PIL. These data may contribute to future systematic reviews of randomised studies of recruitment interventions.

Background The ovarian cancer (OC) preclinical detectable phase (PCDP), defined as the interval during which cancer is detectable prior to clinical diagnosis, remains poorly characterised. We report exploratory analyses from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Methods In UKCTOCS between Apr-2001 and Sep-2005, 101,314 postmenopausal women were randomised to no screening (NS) and 50,625 to annual multimodal screening (MMS) (until Dec-2011) using serum CA-125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA). All provided a baseline blood sample. Women with invasive epithelial OC diagnosed between randomisation and trial censorship (Dec-2014) in the MMS and NS arms with two or more CA-125 measurements, including one within two years of diagnosis were included. OCfree women (2:1 to cases) from the MMS arm provided information on baseline CA-125 distribution. CA-125 measurements were obtained from MMS results, secondary analysis of baseline samples, and medical records. PCDP duration and in-vivo tumour doubling time were estimated using the change-point model underlying ROCA. Early-stage (Stage I and II) PCDP was estimated from a Bayesian model for the probability of early stage given a CA-125 measurement. Findings Of 541 women (2371 CA-125 measurements) with high-grade serous cancer (HGSC), 93% (504/541) secreted CA-125 into the circulation. Median CA-125 PCDP duration for clinically-diagnosed HGSC was 15.2 (IQR 13.1-16.9, 95% IPR 9.6-21.8) months, of which 11.9 (IQR 10.5-13.1, 95% IPR 7.5-16.5) months was in early stage. The median HGSC in-vivo tumour doubling time for cancers secreting CA-125 was 2.9 (IQR 2.3-3.7, 95% IPR 1.5-7.6) months. Interpretation We report a comprehensive characterisation of the OC CA-125 PCDP. The 12-month window for early- stage detection and short tumour doubling time of HGSC provide a benchmark for researchers evaluating novel screening approaches including need to reduce diagnostic workup interval. Equally the fi ndings provide urgent impetus for clinicians to reduce intervals from presentation to treatment onset. Funding NCI Early Detection Research Network, Concord (MA) Detect Ovarian Cancer Early Fund, MRC Clinical Trials Unit at UCL Core Funding. Copyright (c) 2025 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

BACKGROUND:We trialled the first digital pathway (BRCA-DIRECT) aiming to improve capacity for mainstreamed BRCA testing within UK breast oncology services. Patients received standardised digital pretest information, with saliva sampling and consent to testing completed at home. For individualised support, we offered access to a clinical genetics professional via a telephone helpline (TH). METHODS:To evaluate the utilisation, uptake and resource requirements for provision of the TH, we analysed data from structured call logs recorded in the BRCA-DIRECT Study. Mixed-methods analysis included combining quantitative data from call logs and patient demographics with thematic analysis of free-text notes establishing reasons for calls. Additional data were analysed from structured telephone interviews. RESULTS:Calls were received from 201/1140 (17.6%) patients. We identified that 84.6% of calls (274 calls, 1097 min) pertained to 'administrative' support needs only. The remaining 15.4% required a clinical genetics professional (50 calls, 344 min). Of the clinical calls received: 26.0% were placed prior to test consent, 36.0% while awaiting results and 38.0% post results, with median (interquartile) call lengths of 8 (4-10) min; 5.5 (4-10) min; and 5 (3-7) min, respectively. Across all 1140 patients, a mean of 0.3 min of clinical time was required per patient. CONCLUSIONS:Our findings demonstrate that the 'BRCA-DIRECT' model of standardised information provision served most patients, with a minority using the helpline for supplementary clinical information or support. The modest per-patient requirement for clinical time supports the scalability of this model for expanding mainstream genetic testing within UK oncology services.

The use of technology in medical education has been increasing with more students exposed to some form of online learning or tutorials, under the umbrella of virtual learning (VL). Many programmes, particularly those involving virtual reality, have centred on practical skills, such as surgical techniques or anatomical knowledge, rather than communication. The study presented here examined the feasibility and acceptability of a VL module developed to aid communication when handling angry patients and their relatives. Participants were 4th and 5th year medical students at the Brighton and Sussex Medical School. Students were randomly allocated to receive training about having angry conversations in a clinical setting via virtual reality headset or desktop application. Prior to the intervention, everyone completed the SE12 self-efficacy questionnaire, a 5-item confidence measure, and free-response study specific survey. Following the module, they completed another study specific survey, with fixed and free responses, the confidence measure, along with the UTAUT2 questionnaire on acceptance and use of technology. Quantitative data was analysed descriptively, conceptual content analysis was applied to free responses. Participants received a £25 voucher for their time. Twenty students took part in the project. Scores on the SE12 did not differ significantly between intervention arms. Confidence improved across all five categories - recognising responses that diffuse or exacerbate anger, identifying anger signals, remaining calm in hostile situations, moving forward with empathy, and applying techniques to different situations. Responses to the UTAUT2 indicated acceptance of VL, including the psychological safety it provides. Nineteen categories for free text responses were developed via content analysis. Participants spoke frequently about the challenges of navigating anger. There was initial apprehension VL would not feel realistic, though this was largely reversed post-intervention. Students expressed preference for a combination of VL, whichever modality, and face-to-face teaching, recognising benefits of both. Students found the training to be acceptable, providing them with tangible skills. There should be a consideration as to how to incorporate VL, with a mix of face-to-face practice for added realism. Clinical trial number not applicable.

PURPOSE:Multiple myeloma (MM) is a complex haematology malignancy. The terminology required when explaining the disease and treatment options is challenging. Shared informed decision-making demands sufficient knowledge but there is a lack of literature examining the understanding that MM patients and informal caregivers possess. This review synthesises existing literature on patient and caregiver understanding of MM diagnosis, prognosis, and treatment, plus identification of any moderating factors. METHODS:This review followed the Joanna Briggs Institute method for Scoping Reviews. Searches were conducted in MEDLINE, CINAHL, PsycINFO, and grey literature sources. Publications in English, reporting primary data from caregivers or patients with MM with outcomes relating to knowledge and understanding of diagnosis, prognosis or treatment were included. Results from quantitative studies were summarised with descriptive narrative; qualitative studies were analysed thematically. RESULTS:16 papers, 7 quantitative, 9 qualitative, published between 2015 and 2024 were included. None reported objective assessment of understanding. MM patients reported moderate comprehension generally, though disease related knowledge, particularly diagnostic testing, was poor. Discordant perceptions of MM curability were reported; some retaining belief of cure despite acknowledging clinical advice that this was unachievable. Patients and caregivers believed that prognostic knowledge was important and helpful, yet many received insufficient information. CONCLUSIONS:Sparse research had a primary aim of investigating understanding of MM. Findings indicated a need for further research, particularly around understanding of prognosis, and how this relates to decision making. Investigation is also needed regarding educational interventions early in the pathway, with their impact on treatment decisions and quality of life.

Addition of a CDK4/6 inhibitor to endocrine therapy (ET) prolongs survival in HR + /HER2-metastatic breast cancer (MBC). Gastrointestinal side effects, predominantly diarrhoea and abdominal pain, are common in patients receiving abemaciclib. This can potentially increase symptom burden, reduce quality of life (QoL) and affect treatment adherence. This longitudinal mixed-methods study with a 6-month follow-up explored patients’ outcomes and experiences. Participants (n = 44) completed validated QoL measures at study-entry and at 1, 3 and 6 months. Weekly diarrhoea diaries with free-text response options assessed bowel movements and self-management strategies. Optional interviews gathered insight in patients’ experiences. Forty-two participants completed study measures at study-entry and 24 at 6 months. 17/42 reported no gastrointestinal side-effects. Above threshold diarrhoea (≥ 3 loose/liquid stools daily) was reported at least once by 25/42, with 3/42 having persistent symptoms. Strategies to control diarrhoea, employed by 28/42, included dietary modifications, non-prescribed medication-use and nonadherence (dose interruption or reduction). Meaningful decline on the QoL diarrhoea subscale was observed in 12/37 at 1 month, 13/28 at 3 months and 8/23 at 6 months. Free-text analysis showed that diarrhoea disrupted everyday life in those affected. A proportion of this small sample of MBC patients treated with abemaciclib and ET-reported diarrhoea which affected symptom burden and QoL. Close symptom monitoring alongside targeted supportive/educational interventions should be introduced to reduce the negative impact on patients’ lives. ClinicalTrials.gov Identifier: ISRCTN17281696.

Randomised controlled trials are challenging to deliver. There is a constant need to review and refine recruitment and implementation strategies if they are to be completed on time and within budget. We present the strategies adopted in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, one of the largest individually randomised controlled trials in the world. The trial recruited over 202,000 women (2001–5) and delivered over 670,000 annual screens (2001–11) and over 3 million women-years of follow-up (2001–20). Key to the successful completion were the involvement of senior investigators in the day-to-day running of the trial, proactive trial management and willingness to innovate and use technology. Our underlying ethos was that trial participants should always be at the centre of all our processes. We ensured that they were able to contact either the site or the coordinating centre teams for clarifications about their results, for follow-up and for rescheduling of appointments. To facilitate this, we shared personal identifiers (with consent) with both teams and had dedicated reception staff at both site and coordinating centre. Key aspects were a comprehensive online trial management system which included an electronic data capture system (resulting in an almost paperless trial), biobanking, monitoring and project management modules. The automation of algorithms (to ascertain eligibility and classify results and ensuing actions) and processes (scheduling of appointments, printing of letters, etc.) ensured the protocol was closely followed and timelines were met. Significant engagement with participants ensured retention and low rates of complaints. Our solutions to the design, conduct and analyses issues we faced are highly relevant, given the renewed focus on trials for early detection of cancer. Future work There is a pressing need to increase the evidence base to support decision making about all aspects of trial methodology. Trial registration ISRCTN-22488978; ClinicalTrials.gov-NCT00058032. Funding This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/46/01. The long-term follow-up UKCTOCS (2015 20) was supported by National Institute for Health and Care Research (NIHR HTA grant 16/46/01), Cancer Research UK, and The Eve Appeal. UKCTOCS (2001–14) was funded by the MRC (G9901012 and G0801228), Cancer Research UK (C1479/A2884), and the UK Department of Health, with additional support from The Eve Appeal. Researchers at UCL were supported by the NIHR UCL Hospitals Biomedical Research Centre and by the MRC Clinical Trials Unit at UCL core funding (MC_UU_00004/09, MC_UU_00004/08, MC_UU_00004/07). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the UK Department of Health and Social Care.

The complexity of advanced breast cancer (ABC) and its treatment landscape makes communication between healthcare professionals (HCPs) and patients particularly challenging. It is essential that all HCPs receive comprehensive communication skills training starting at medical or nursing school and continuing throughout their careers. Effective communication can improve trust, treatment adherence, and ultimately, outcomes; it also facilitates shared and educated decision-making, all of which is crucial to ensure patients receive the most appropriate treatment and care.This manuscript explores the global landscape of communication skills training, highlights remaining communication gaps, and assesses the preference for, and implementation of, shared decision-making in clinical practice. It draws on research conducted for the ABC Global Alliance's Global Decade Report 2.0. The main findings are: a) Communication skills trainings now cover a broader range of topics; b) People with ABC report their broader communication needs are often not met; c) Doctors and patients differ in their preferences for shared decision-making in ABC; d) Improving ABC care requires patients to feel supported in expressing their needs.The findings from the ABC Global Alliance's Global Decade Report 2.0 have informed the development of a new ABC Global Charter. The ABC Global Charter 2.0 defines ten new achievable and measurable goals for the decade 2025–2035, aiming at improving the lives of people living with ABC worldwide.

The IMPACTOR study (IMPact of AbemaCiclib on patienTs’ rOles and Responsibilities–ISRCTN17281696) was developed to capture experiences of women with MBC being treated with abemaciclib in a real-world setting. The primary aim was to explore changes to quality of life over time and our secondary aim was to understand these changes in detail via qualitative interviews, as presented here. A singular interview was offered to participants who had expressed an interest at the point of consent. These were all conducted remotely using a semi-structured interview topic guide. Twenty interviews were completed and analysed using a framework approach to thematic analysis. Eight themes were developed—COVID-19, experience of MBC, side effects, side effect management, treatment information and support, relationship impacts, impact on daily life, and finances and employment. It was apparent that participants faced side effects from treatment but undertook steps to manage these as much as possible. Adaptations were often led by a belief about the benefits of remaining on treatment. Adjustments ranged from modifying routines to carrying personal hygiene supplies when out in public in case of diarrhoea. While this was anticipated, other side effects were less well known with variable clinical support and available information. Family support was raised frequently, predominantly in relation to the impact MBC had on roles and relationships. Themes from this work can be thought of via theories about treatment belief and adherence, such as the common-sense and self-regulation models, as participants reflected on both emotional and cognitive coping strategies. Trial registration - ISRCTN17281696.

This article consists of a citation of a published article describing research funded by the Health Technology Assessment programme under project number 16/46/01, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.3390/cancers13040858 Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who were randomised to annual screening with transvaginal ultrasound attended annual incidence screening between 28 April 2002 and 31 December 2011. Transvaginal ultrasound was used both as the first and the second line test. Participants were followed up through electronic health record linkage and postal questionnaires. Out of 280,534 annual incidence screens, 960 women underwent screen-positive surgery. 113 had ovarian/tubal cancer (80 invasive epithelial). Of the screen-detected invasive epithelial cancers, 37.5% (95% CI: 26.9–49.0) were Stage I/II. An additional 52 (50 invasive epithelial) were diagnosed within one year of their last screen. Of the 50 interval epithelial cancers, 6.0% (95% CI: 1.3–16.5) were Stage I/II. For detection of all ovarian/tubal cancers diagnosed within one year of screen, the sensitivity, specificity, and positive predictive values were 68.5% (95% CI: 60.8–75.5), 99.7% (95% CI: 99.7–99.7), and 11.8% (95% CI: 9.8–14) respectively. When the analysis was restricted to invasive epithelial cancers, sensitivity, specificity and positive predictive values were 61.5% (95% CI: 52.6–69.9); 99.7% (95% CI: 99.7–99.7) and 8.3% (95% CI: 6.7–10.3), with 12 surgeries per screen positive. The low sensitivity coupled with the advanced stage of interval cancers suggests that ultrasound scanning as the first line test might not be suitable for population screening for ovarian cancer. Trial registration: ISRCTN22488978. Registered on 6 April 2000. This publication was funded by the Health Technology Assessment programme as a part of award number 16/46/01. This article reports on one component of the research award Long term impact of screening on ovarian cancer mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/16/46/01] https://doi.org/10.3390/cancers13040858

527 Background: We developed two 8 min films to aid patients’ understanding about gene expression profiling (GEP) tests (Oncotype DX or Prosigna) in breast cancer. A previous study of 120 women without breast cancer demonstrated significantly better knowledge after film viewing compared to that after reading written materials (1). We present results of an RCT testing the films’ utility when given in clinics to women with early HR+ breast cancer for whom the benefit of chemotherapy was uncertain. Methods: Standard information policies about GEP testing differ, some clinics may provide patients with leaflets, others only verbal information. Patients who had consented to a GEP test were invited to join IMPARTER4. At baseline they completed anxiety trait/state and intolerance of uncertainty (IoU) questionnaires and were then randomized to Gp A (hospitals’ standard information alone) or Gp B (standard information plus the relevant GEP patient film). Prior to learning their risk of recurrence scores, researchers interviewed patients and probed their understanding and knowledge about GEP testing together with the role risk scores had in helping determine management options (hormone therapy plus or minus chemotherapy). Following test result discussions with oncologists, patients completed two further questionnaires measuring anxiety and decisional conflict. Treating physicians all completed IoU questionnaires once at baseline, Satisfaction with their clinical interviews conducted with patients about risk scores and management decisions was measured using a study specific questionnaire. Results: To date 225/230 patients from 18 UK hospitals (Gp A (standard information alone) n=103; Gp B (standard plus information film) n=122) were seen by 79 physicians. Socio-demographics, anxiety trait/state and IoU did not differ between groups. Prior to the results discussion, written information was given to 128/225 (56.9%), (66 in Gp A, and 62 in Gp B). Linear regression analyses (adjusted for age and education) showed that mean knowledge scores were higher in those receiving standard information plus the film (Gp B), (2.5 points (95% C.I:1.7-3.4) p<0.001). There was a trend for longer consultations in those patients having standard information alone (Gp A) (12.6% v 8.2%), who also asked more difficult questions (9.7% v 2.5%). Conclusions: Patient information films significantly improved knowledge about GEP tests and recurrence risk results compared to standard verbal and written information alone. Furthermore, the films appeared to enable shorter, more informed discussions between patients and their oncologists about the addition of chemotherapy to hormone therapy alone. Versions in Spanish, Italian, French, Urdu, Hindi, Gujarati, Punjabi, and Bengali are freely available. 1. Fallowfield et al, Br Ca Res & Tmt. 2022. Clinical trial information: 28497350.

BackgroundPeople living with metastatic breast cancer (MBC) may have different support requirements to those with early stage breast cancer (EBC). These differences can be substantial, particularly as care pathways and information are often designed around the latter. There is limited understanding of how these discrepancies impact patients with MBC.AimsIn the LIMBER study (Living with Metastatic Breast Cancer), we explored the distinct and unmet needs of people living with MBC.MethodsIn collaboration with people living with MBC and healthcare professionals (HCPs), we developed an online survey comprising fixed and free text responses. Fixed responses and overall study demographics from the main LIMBER study have been published elsewhere. A framework analysis of the free text comments is reported here.ResultsThe resulting thematic map has seven main themes - friends and family, reactions of others, healthcare professionals, systems & processes, knowledge & information, outlook & goals and wellbeing. Participants reflected that comments made by friends and family were often well-meaning but showed misunderstanding of the disease. This was particularly noticeable in understanding the difference between MBC and EBC. There were references to the lack of support and information from HCPs.ConclusionsThe analysis of free text comments from this survey demonstrates the impact that MBC can have, particularly without robust support or accessible information. Understanding areas where patients have outstanding needs provides insight into how best to promote coping strategies and improved quality of life, while informing those who provide informal and formal care.