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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.

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.

Towards a community-driven definition of community wellbeing: A qualitative study of residents

by Camilla Michalski, Apira Ragunathan, Adrian Foster, Lief Pagalan, Casey Chu, Lori M. Diemert, John F. Helliwell, Diana Urajnik, Ruth Speidel, Tina Malti, Dianne Fierheller, Laura Fusca, Ian Zenlea, Scott McKean, Laura C. Rosella

Background

Understanding what promotes or hinders a community’s capacity to serve the priorities of its residents is essential for the alignment of citizen needs and governance. Participatory approaches that engage community residents on the topic of community wellbeing are useful methods for defining outcomes that reflect a community’s goals and priorities. Using qualitative focus group methods, the aim of this study was to outline bottom-up definitions of community wellbeing from a diverse pool of community residents in Ontario, Canada.

Methods

Semi-structured, two-hour group interviews were conducted with adult (≥18 years) participants (N = 15) residing in four communities across Canada’s largest province of Ontario. Participants were purposively selected from a pool of screening questionnaires to ensure diverse group compositions based on race, gender, age, and educational attainment. Interviews were thematically analysed using descriptive and interpretive methods to characterize resident conceptions of community wellbeing.

Results

Focus group participants were between 18 and 75 years of age and most had lived in their local community for 5 or more years. Four major themes emerged: (1) a sense of community belonging is cultivated through shared spaces, routines, support, and identities; (2) a community constitutes the amenities and social contexts that enable residents to thrive; (3) effective regional decision-making must be community-informed; and (4) the wellbeing of a community relies on equal opportunities for engagement and participation.

Conclusions

Residents described their communities and their associated wellbeing as a combination of accessible amenities and opportunities to engage without marginalization. This study underscores the value of participatory approaches in community wellbeing research, where the viewpoint and life experience of residents is used to inform local decision-making and service delivery. Future research will capture more diverse perspectives towards community belonging, particularly from community newcomers, for the development of regionally appropriate indicators of community wellbeing.

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