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Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)

Por: Pal · A. · Stapleton · S. · Yap · C. · Lai-Kwon · J. · Daly · R. · Magkos · D. · Baikady · B. R. · Minchom · A. · Banerji · U. · De Bono · J. · Karikios · D. · Boyle · F. · Lopez · J.
Introduction

Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.

Methods and analysis

This is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).

Ethics and dissemination

Ethics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.

Trial registration number

NCT04407676; Pre-results.

A qualitative exploration of prodromal myocardial infarction fatigue experienced by women

Abstract

Aims and objectives

The purpose of this study was to explore adult women's unique and shared experiences of prodromal myocardial infarction fatigue.

Background

Fatigue is the most prevalent symptom experienced by women in the weeks and months before myocardial infarction. However, dimensions of this fatigue, such as timing, distress, intensity, quality, patterns and associated characteristics have not been established through studies of this symptom. A lack of understanding of the characteristics of myocardial infarction fatigue and the context in which it occurs makes clinical decision‐making difficult.

Design

A qualitative, multiple case study guided by the Theory of Unpleasant Symptoms.

Methods

Women were purposively enrolled from a large hospital in the Midwestern USA. Semi‐structured, audio‐recorded interviews were conducted during hospitalisation and at 2–3 months postdischarge; women were also provided with a journal. A supplementary interview with family members and electronic health record review also assisted in data triangulation. Analysis was inductive and conducted within and across cases, using coding and categorisation, counting, clustering, visual displays of data and thematic development. The SRQR checklist was used in reporting the study.

Results

Ten women, with a median age of 60, participated. Fatigue was described primarily using the terms tiredness and lack of energy, though some women described generalised weakness and cognitive fog. This fatigue was unusual and a notable change from baseline. Many women described significant difficulties performing activities of daily living due to fatigue.

Conclusions

The findings of this study will advance symptom science and an understanding of prodromal myocardial infarction fatigue. Future instrument development or selection of instruments for quantitative work will be aided by this study.

Relevance to clinical practice

This study provides a clearer picture of prodromal myocardial infarction fatigue experienced by women, aiding healthcare professionals in understanding and identifying this symptom.

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