Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial).

INTRODUCTION: Insomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041). METHODS: The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health. DISSEMINATION: Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023. STRENGTHS AND LIMITATIONS OF THIS STUDY: This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.

Materialising contexts: virtual soundscapes for real-world exploration.

This article presents the results of a study based on a group of participants' interactions with an experimental sound installation at the National Science and Media Museum in Bradford, UK. The installation used audio augmented reality to attach virtual sound sources to a vintage radio receiver from the museum's collection, with a view to understanding the potentials of this technology for promoting exploration and engagement within museums and galleries. We employ a practice-based design ethnography, including a thematic analysis of our participants' interactions with spatialised interactive audio, and present an identified sequence of interactional phases. We discuss how audio augmented artefacts can communicate and engage visitors beyond their traditional confines of line-of-sight, and how visitors can be drawn to engage further, beyond the realm of their original encounter. Finally, we provide evidence of how contextualised and embodied interactions, along with authentic audio reproduction, evoked personal memories associated with our museum artefact, and how this can promote interest in the acquisition of declarative knowledge. Additionally, through the adoption of a functional and theoretical aura-based model, we present ways in which this could be achieved, and, overall, we demonstrate a material object's potential role as an interface for engaging users with, and contextualising, immaterial digital audio archival content.

A need for clarity on surgical management of breast sarcoma: Scottish sarcoma network guidelines and regional audit.

Currently, there are no comprehensive breast sarcoma guidelines in the UK. There is therefore a need for guidelines to clarify surgical management, which we have based on data from our regional audit, current evidence, and consensus between West of Scotland Breast Cancer and Scottish Sarcoma Managed Clinical Networks. Methods and results: From 2007 to 2019, 46 patients were treated with breast sarcoma in the West of Scotland. Sarcoma Centre versus Peripheral Hospitals: Incomplete excision rate was 0% at sarcoma centre and 50% at peripheral hospitals (p = 0.0002, Odds Ratio 43). For angiosarcoma, 0% positive margin at the sarcoma centre versus 62.5% at the peripheral unit (p = 0.0036, odds ratio 39.3). Tumours treated at the sarcoma centre were larger than those treated at peripheral hospitals (92.5 versus 39.7 mm, p = 0.0009). WLE (wide local excision) versus mastectomy: Out of eight WLE patients, seven (87.5%) had positive margins, with 6 of these patients proceeding to mastectomy (i.e. 75% WLE patients ultimately had a mastectomy). The positive margin rate was significantly higher in WLE (87.5%) than in mastectomy (10.3%) (p = 0.0001, odds ratio 60.7). Survival: No difference was noted between the sarcoma centre and peripheral hospitals for overall survival (p = 0.43), stratified for tumours <5 cm (p = 0.16), and disease-free survival (p = 0.45). Conclusions: Our data strongly suggest that specific guidelines are needed for breast sarcoma, and that managing these patients according to breast carcinoma protocols in peripheral hospitals is sub-optimal. We recommend centralisation of breast sarcoma patient care to a specialist sarcoma centre, with WLE not recommended as a firstline surgical option given both the high rates of incomplete excision and subsequent need for completion mastectomy.

A prospective cohort study of the safety of breast cancer surgery during COVID-19 pandemic in the West of Scotland.

INTRODUCTION: In order to minimise the risk of breast cancer patients for COVID-19 infection related morbidity and mortality prioritisation of care has utmost importance since the onset of the pandemic. However, COVID-19 related risk in patients undergoing breast cancer surgery has not been studied yet. We evaluated the safety of breast cancer surgery during COVID-19 pandemic in the West of Scotland region. METHODS: A prospective cohort study of patients having breast cancer surgery was carried out in a geographical region during the first eight weeks of the hospital lockdown and outcomes were compared to the regional cancer registry data of pre-COVID-19 patients of the same units (n = 1415). RESULTS: 188 operations were carried out in 179 patients. Tumour size was significantly larger in patients undergoing surgery during hospital lockdown than before (cT3-4: 16.8% vs. 7.4%; p < 0.001; pT2 - pT4: 45.5% vs. 35.6%; p = 0.002). ER negative and HER-2 positive rate was significantly higher during lockdown (ER negative: 41.3% vs. 17%, p < 0.001; HER-2 positive: 23.4% vs. 14.8%; p = 0.004). While breast conservation rate was lower during lockdown (58.6% vs. 65%; p < 0.001), level II oncoplastic conservation was significantly higher in order to reduce mastectomy rate (22.8% vs. 5.6%; p < 0.001). No immediate reconstruction was offered during lockdown. 51.2% had co-morbidity, and 7.8% developed postoperative complications in lockdown. There was no peri-operative COVID-19 infection related morbidity or mortality. CONCLUSION: breast cancer can be safely provided during COVID-19 pandemic in selected patients.

A population-based audit of surgical practice and outcomes of oncoplastic breast conservations in Scotland - An analysis of 589 patients.

INTRODUCTION: Current evidence for oncoplastic breast conservation (OBC) is based on single institutional series. Therefore, we carried out a population-based audit of OBC practice and outcomes in Scotland. METHODS: A predefined database of patients treated with OBC was completed retrospectively in all breast units practicing OBC in Scotland. RESULTS: 589 patients were included from 11 units. Patients were diagnosed between September 2005 and March 2017. High volume units performed a mean of 19.3 OBCs per year vs. low volume units who did 11.1 (p = 0.012). 23 different surgical techniques were used. High volume units offered a wider range of techniques (8-14) than low volume units (3-6) (p = 0.004). OBC was carried out as a joint operation involving a breast and a plastic surgeon in 389 patients. Immediate contralateral symmetrisation rate was significantly higher when OBC was performed as a joint operation (70.7% vs. not joint operations: 29.8%; p < 0.001). The incomplete excision rate was 10.4% and was significantly higher after surgery for invasive lobular carcinoma (18.9%; p = 0.0292), but was significantly lower after neoadjuvant chemotherapy (3%; p = 0.031). 9.2% of patients developed major complications requiring hospital admission. Overall the complication rate was significantly lower after neoadjuvant chemotherapy (p = 0.035). The 5 year local recurrence rate was 2.7%, which was higher after OBC for DCIS (8.3%) than invasive ductal cancer (1.6%; p = 0.026). 5-year disease-free survival was 91.7%, overall survival was 93.8%, and cancer-specific survival was 96.1%. CONCLUSION: This study demonstrated that measured outcomes of OBC in a population-based multi-centre setting can be comparable to the outcomes of large volume single centre series.

Six-year follow-up of patients treated with oncoplastic reduction mammoplasty: A cohort study.

BACKGROUND: Current evidence for the oncological safety of oncoplastic breast conservation is poor as it is based mostly on short-term follow-up data. Hence, we report long-term recurrence rates in patients treated with oncoplastic reduction mammoplasty (ORM). METHODS: A prospectively maintained database was searched to identify patients who underwent ORM between 2005 and 2010. A retrospective review of medical records was carried out, including patients with ductal carcinoma in situ and invasive breast cancer. RESULTS: Follow-up data from 65 consecutive patients with ORM were reviewed, of which 50 patients were eligible to measure long-term recurrence rates. The average weight of the resected tissue was 272 g altogether. The mean preoperative tumour size was 2.95 cm on imaging. 64% of patients had stage II - III cancers. Incomplete excision rate after ORM was 16.1%, completion mastectomy rate was 10.7%. During a median follow-up of 72 months, 2% local, 6% distant recurrence rates were detected. The breast cancer-specific survival rate was 96% per cent. CONCLUSIONS: Based on these long-term follow-up data, ORM is an oncologically safe treatment option.

Imaging Results Following Oncoplastic and Standard Breast Conserving Surgery.

BACKGROUND: Oncoplastic breast-conserving surgery (OBCS) requires more complex surgical techniques than standard wide local excision (WLE) and the postoperative complication rate may be higher. Since these can have an impact on postoperative imaging, we compared imaging and biopsy results after OBCS and WLE. METHODS: Findings for patients undergoing OBCS (n = 83) or standard WLE (n = 128) were compared. Numbers, indications and outcomes of mammograms, breast ultrasounds, magnetic resonance imaging scans and biopsies done within 2 years after surgery were analysed. RESULTS: OBCS was applied for more advanced malignancy. Significantly more patients required breast ultrasound after OBCS than WLE (20/71 vs. 17/116; p = 0.024). Breast Imaging Reporting and Data System (BI-RADS) category 3 or 4 ultrasound results were found only in patients with OBCS (6/29 vs. 0/19; p = 0.034). Significantly more biopsies were required after OBCS (9/71 vs. 3/116; p = 0.006). New lumps or lumpiness were the commonest indications, and pathology confirmed fat necrosis in the majority (7/12). The rate of fat necrosis after OBCS was 18% on clinical examination (13/71), 15% with ultrasound (11/71) and 7% confirmed on pathology (5/71). CONCLUSION: Patients treated with OBCS require significantly more ultrasound scans and consequent biopsies than patients who underwent WLE. This is mainly due to fat necrosis developing after OBCS in the majority of cases.

On the nature and scope of reported child maltreatment in high-income countries: opportunities for improving the evidence base.

Although high-income countries share and value the goal of protecting children from harm, national data on child maltreatment and the involvement of social services, the judiciary and health services remain relatively scarce. To explore potential reasons for this, a number of high-income countries across the world (Belgium, Canada, Germany, the Netherlands, New Zealand, South Korea, Switzerland and the United States) were compared. Amongst other aspects, the impact of service orientation (child protection-vs-family-services-orientated), the complexity of systems, and the role of social work as a lead profession in child welfare are discussed. Special consideration is given to indigenous and minority populations. The call for high-income countries to collect national data on child maltreatment is to promote research to better understand the risks to children. Its remit ranges well beyond these issues and reflects a major gap in a critical resource to increase prevention and intervention in these complex social situations. Fortunately, initiatives to close this gap are increasing.

Patterns and predictors of early recurrence in postmenopausal women with estrogen receptor-positive early breast cancer.

Previous studies suggest that disease recurrence peaks at around 2 years in patients with early stage breast cancer (EBC), but provide no data regarding recurrence type. This retrospective analysis aimed to identify early recurrence types and risk factors in estrogen receptor-positive (ER+) EBC patients treated with adjuvant tamoxifen following breast cancer surgery. Postmenopausal women diagnosed with ER+ EBC from 1995 to 2004 were evaluated. Annual hazard ratios (HR) for recurrence at different sites were calculated. Time-dependent Cox regression analysis was used to identify predictors of recurrence within 2.5 years of diagnosis, including factors that were more strongly predictive of early than later recurrence. Of 3,614 patients evaluated, 476 developed recurrence during the 5-year median follow-up. Cumulative recurrence rates at 2.5 years (95% confidence interval) were: overall 6.3% (5.5-7.1), locoregional 1.1% (0.7-1.5), contralateral 0.5% (0.3-0.7), and distant 4.8% (4.0-5.6). The annual HR of overall recurrence peaked at 2 years (4.3% per annum). The majority of this peak represented distant recurrence (3.4% per annum). In Cox regression analysis, tumor size and grade, lymph node involvement, lymphovascular invasion, and symptomatic presentation were significant independent predictors of early recurrence. Age at diagnosis was independently predictive of recurrence within 2.5 years of diagnosis but not later recurrence. This study identified an early recurrence peak at 2 years, most of which were distant recurrences. Implementing an aromatase inhibitor after an initial 2-3 years of tamoxifen fails to address this early peak of distant recurrence and the potential breast cancer-associated mortality.