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Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

Beyond the burn: An observational study of cardiovascular risk in burn survivors in the north of Iran

Abstract

Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.

The significance of parental mentalizing for four-year-old children’s solitary pretend play

by Johanne Smith-Nielsen, Anne Christine Stuart, Katrine Isabella Wendelboe, Ida Egmose, Camilla Overbye Roos, Mette Skovgaard Væver

Background

Pretend play is a signature behavior of early childhood and is considered to reflect the child’s emerging symbolic function, enabling the interpretation of social signals, language development, and emotion understanding. While theory links parental mentalizing with children’s pretend play, only a few studies have investigated this association. These studies are limited to infancy and early toddlerhood, and child pretend play is assessed during play with an adult (social play). Based on the assumption that child solitary pretend play reflects the child’s ‘baseline’ pretend play ability, in this study, we investigated children’s pretend play at its peak, i.e., during the preschool age, without the facilitation of another player. The overall objective was to investigate if parental mentalizing increases pretend play complexity in children.

Methods

The sample consisted 99 Danish mothers and their 4-year-old children. Employing a cross-sectional design, we hypothesized that parental mental state language, as an indicator of ‘online’ mentalizing during interaction with the child, is a mechanism through which ‘offline’ mentalizing, measured as parental reflective functioning, is associated with child solitary pretend play. Child pretend play complexity was observed and coded with an adapted version of the 12-Step Play Scale. Maternal offline mentalizing was assessed with the Parental Reflective Functioning Questionnaire, and maternal online mentalizing was assessed by coding the mothers’ mental state language during interaction with the child using a modified version of the mind-mindedness coding scheme.

Results

While there was no direct effect of maternal offline reflective functioning on child pretend play, online mental state language mediated the link between offline maternal reflective functioning and child pretend play.

Conclusions

These results provide support for the theoretically assumed link between parental mentalizing and children’s capacity for pretend play. Furthermore, our study contributes to the literature on parental mentalization, suggesting that parental mentalizing facilitates child development only if the parent can translate this ability into ’mentalizing in action’.

Characterising the gut microbiome of stranded harbour seals (<i>Phoca vitulina</i>) in rehabilitation

by Ana Rubio-Garcia, Aldert L. Zomer, Ruoshui Guo, John W. A. Rossen, Jan H. van Zeijl, Jaap A. Wagenaar, Roosmarijn E. C. Luiken

Animal rehabilitation centres provide a unique opportunity to study the microbiome of wild animals because subjects will be handled for their treatment and can therefore be sampled longitudinally. However, rehabilitation may have unintended consequences on the animals’ microbiome because of a less varied and suboptimal diet, possible medical treatment and exposure to a different environment and human handlers. Our study describes the gut microbiome of two large seal cohorts, 50 pups (0–30 days old at arrival) and 23 weaners (more than 60 days old at arrival) of stranded harbour seals admitted for rehabilitation at the Sealcentre Pieterburen in the Netherlands, and the effect of rehabilitation on it. Faecal samples were collected from all seals at arrival, two times during rehabilitation and before release. Only seals that did not receive antimicrobial treatment were included in the study. The average time in rehabilitation was 95 days for the pups and 63 days for the weaners. We observed that during rehabilitation, there was an increase in the relative abundance of some of the Campylobacterota spp and Actinobacteriota spp. The alpha diversity of the pups’ microbiome increased significantly during their rehabilitation (p-value
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