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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.

Perinatal healthcare for women at risk of childrens social care involvement: a qualitative survey of professionals in England

Por: Grant · C. · Bicknell-Morel · T. · Lever Taylor · B. · Powell · C. · Blackburn · R. M. · Lacey · R. · Woodman · J.
Background

Women with complex health needs are more at risk of having children’s social care involvement with their newborns than other mothers. Around the time of pregnancy, there are opportunities for health services to support women with these needs and mitigate the risk of mother–baby separation. Yet little is known about healthcare professionals’ experiences of providing this support.

Methods

We administered an online survey to perinatal healthcare professionals across England (n=70 responders), including midwives, obstetricians, perinatal psychologists/psychiatrists and health visitors. We asked about their experiences of providing care for pregnant women with chronic physical conditions, mental health needs, intellectual/developmental disabilities and substance use disorders, who might be at risk of children’s social care involvement. We conducted a framework analysis.

Results

We constructed five themes from participant data. These include (1) inaccessible healthcare for women with complex needs, (2) the challenges and importance of restoring trust, (3) services focusing on individuals, not families, (4) the necessity and caution around multidisciplinary support and (5) underfunded services inhibiting good practice.

Conclusions

Women who are at risk of children’s social care involvement will likely experience perinatal healthcare inequities. Our findings suggest that current perinatal healthcare provision for this population is inadequate and national guidelines need updated to inform support.

Electroacupuncture use for treatment of taxane-induced peripheral neuropathy in patients with breast cancer: protocol for a pilot, randomised, blinded, sham-controlled trial (EA for CIPN)

Por: Choi · V. · Park · S. B. · Lacey · J. · Kumar · S. · Heller · G. · Grimison · P.
Introduction

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy.

Methods and analysis

The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy.

Ethics and dissemination

The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent’s Hospital Sydney and Chris O’Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

ACTRN12622000081718.

Does Health & Her app use improve menopausal symptoms? A longitudinal cohort study

Por: Andrews · R. · Lancastle · D. · Bache · K. · Lacey · A. S.
Objectives

The Health & Her app provides menopausal women with a means of monitoring their symptoms, symptom triggers and menstrual periods, and enables them to engage in a variety of digital activities designed to promote well-being. This study aimed to examine whether sustained weekly engagement with the app is associated with improvements in menopausal symptoms.

Design

A pre–post longitudinal cohort study.

Setting

Analysed data collected from Health & Her app users.

Participants

1900 women who provided symptom data via the app across a 2-month period.

Primary and secondary outcome measures

Symptom changes from baseline to 2 months was the outcome measure. A linear mixed effects model explored whether levels of weekly app engagement influenced symptom changes. Secondary analyses explored whether app-usage factors such as total number of days spent logging symptoms, reporting triggers, reporting menstrual periods and using in-app activities were independently predictive of symptom changes from baseline. Covariates included hormone replacement therapy use, hormonal contraceptive use, present comorbidities, age and dietary supplement use.

Results

Findings demonstrated that greater engagement with the Health & Her app for 2 months was associated with greater reductions in symptoms over time. Daily use of in-app activities and logging symptoms and menstrual periods were each independently associated with symptom reductions.

Conclusions

This study demonstrated that greater weekly engagement with the app was associated with greater reductions in symptoms. It is recommended that women be made aware of menopause-specific apps, such as that provided by Health & Her, to support them to manage their symptoms.

Planning for healthcare services during the COVID-19 pandemic in the Southeast of England: a system dynamics modelling approach

Por: George · A. · Lacey · P. · Badrinath · P. · Gray · A. · Turner · P. · Harwood · C. · Gregson · M.
Objectives

To develop, test, validate and implement a system dynamics model to simulate the pandemic progress and the impact of various interventions on viral spread, healthcare utilisation and demand in secondary care.

Design

We adopted the system dynamics model incorporating susceptible, exposed, infection and recovery framework to simulate the progress of the pandemic and how the interventions for the COVID-19 response influence the outcomes with a focus on secondary care.

Setting

This study was carried out covering all the local health systems in Southeast of England with a catchment population of six million with a specific focus on Kent and Medway system.

Participants

Six local health systems in Southeast of England using Kent and Medway as a case study.

Interventions

Short to medium ‘what if’ scenarios incorporating human behaviour, non-pharmaceutical interventions and medical interventions were tested using the model with regular and continuous feedback of the model results to the local health system leaders for monitoring, planning and rapid response as needed.

Main outcome measures

Daily output from the model which included number infected in the population, hospital admissions needing COVID-19 care, occupied general beds, continuous positive airway pressure beds, intensive care beds, hospital discharge pathways and deaths.

Results

We successfully implemented a regional series of models based on the local population needs which were used in healthcare planning as part of the pandemic response.

Conclusions

In this study, we have demonstrated the utility of system dynamics modelling incorporating local intelligence and collaborative working during the pandemic to respond rapidly and take decisions to protect the population. This led to strengthened cooperation among partners and ensured that the local population healthcare needs were met.

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