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Mesalamine for Colorectal Cancer Prevention Programme in Lynch syndrome (MesaCAPP): a multicentre, multinational, randomised, two-arm, double-blind, phase II clinical study with mesalamine or placebo in carriers with Lynch syndrome - a study protocol

Por: Backman · A.-S. · Frank · A. · Lindberg · L. J. · Ljungman · D. · Silander · G. · Gustafsson · R. J. · Bozso · T. · Schmidt · P. T. · Ingre · M. · Mittlbock · M. · Löwbeer · C. · Marsal · J. · Lindblom · A. · Tham · E. · Therkildsen · C. · Gasche · C. · The International MesaCAPP Stu
Introduction

Lynch syndrome (LS) carriers have a 20–46% lifetime risk of colorectal cancer (CRC) due to mismatch repair gene variants. Mesalamine (5-ASA, 5-aminosalicylic acid), used safely in patients with ulcerative colitis, may reduce CRC risk in LS by decreasing microsatellite instability, a key driver of LS-related cancer. This study evaluates 5-ASA’s efficacy as a tolerable chemopreventive drug, aiming to improve long-term CRC prevention in LS.

Methods and analysis

This multicentre, multinational, randomised, double-blind, two-arm, phase II clinical study will compare the effects of a 2-year daily intake of 5-ASA (2000 mg) to placebo in LS carriers. The primary objective is to assess whether mesalamine reduces colorectal neoplasia, both benign and malignant, compared with placebo in LS carriers, as detected by colonoscopy at the end of the treatment period (24 months±1 month) and on study completion. Secondary objectives include evaluating whether 5-ASA reduces neoplasia/tumour multiplicity and progression compared with placebo at specified time points, examining variations in the effects of 5-ASA versus placebo based on cancer history, sex and age (

Ethics and dissemination

The trial is currently open for enrolment, having received ethical approval from the Regional Ethical Review Board in Stockholm and funding from the Swedish Research Council. The study protocol is the finalised V.10.0 (11 April 2024), transitioned to the European Clinical Trials Information System. LS remains underdiagnosed, which may limit recruitment. The results are of global interest and will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

ClinicalTrials.gov: NCT04920149. EudraCT: 2019-003011-55. EU CT: 2024-514765-19-01.

Reflection Supports Newly Graduated Nurses' Professional Development When Transitioning Into Practice

ABSTRACT

Aim

To describe newly graduated nurses' experiences of reflection as a support for professional development during the initial months of their transition while caring for patients in a hospital setting.

Design

A qualitative descriptive design.

Methods

Four focus groups with 20 newly graduated nurses participating in a professional development programme at aregion in Sweden were conducted in 2023. The data were analysed using qualitative content analysis.

Findings

The analysis identified one main category: Reflection supports newly graduated nurses' professional development during their transition. This main category includes three generic categories: (1) Reflection with peers in a regularly structured dialogue group strengthens the professional role; (2) reflection with experienced healthcare instructors in learning activities enhances the mastery of care tasks; and (3) reflection with experienced colleagues in the workplace enhances task performance. Structured reflection in dialogue groups and interactive learning activities within the Professional Development Programme facilitated deeper reflections on caring experiences.

Conclusions

Newly graduated nurses reported that regularly structured reflection, adequate space, and established trust were essential to their professional development. While the professional development programme provided opportunities, variations in the workplace environment led to unequal conditions for reflective practice.

Implications for the Profession

Addressing the need for reflection among newly graduated nurses is crucial for organisations to facilitate their transition. Establishing structures for reflection on caring experiences within introduction programmes can support their professional development.

Impact

Reflective practice in complex and challenging hospital settings can support the professional development of newly graduated nurses.

Reporting Method

The Consolidated Criteria for Reporting Qualitative Research (COREQ) was adhered to.

Patient or Public Contributions

No patient or public contributions.

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