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Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study

The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients...

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Published in:Current controlled trials in cardiovascular medicine 2023-10, Vol.24 (1), p.670-670, Article 670
Main Authors: Wheelwright, Sally, Matthews, Lucy, Jenkins, Valerie, May, Shirley, Rea, Daniel, Fairbrother, Pat, Gaunt, Claire, Young, Jennie, Pirrie, Sarah, Wallis, Matthew G, Fallowfield, Lesley
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cited_by cdi_FETCH-LOGICAL-c564t-e1afeb80c7799d1d5c80d2e6dbbde628f0ed8c567abbe81c1939bd360d69c8c33
cites cdi_FETCH-LOGICAL-c564t-e1afeb80c7799d1d5c80d2e6dbbde628f0ed8c567abbe81c1939bd360d69c8c33
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container_title Current controlled trials in cardiovascular medicine
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creator Wheelwright, Sally
Matthews, Lucy
Jenkins, Valerie
May, Shirley
Rea, Daniel
Fairbrother, Pat
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Young, Jennie
Pirrie, Sarah
Wallis, Matthew G
Fallowfield, Lesley
description The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented. Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews. Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference. Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials. ISRCTN27544579, prospectively registered on 22 May 2014.
doi_str_mv 10.1186/s13063-023-07703-4
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Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented. Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews. Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference. Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials. 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BioMed Central Ltd., part of Springer Nature.</rights><rights>COPYRIGHT 2023 BioMed Central Ltd.</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). 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Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented. Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews. 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subjects Analysis
Anxiety
Biopsy
Breast cancer
Cancer
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating - diagnosis
Carcinoma, Intraductal, Noninfiltrating - surgery
Care and treatment
Clinical trials
Consent
DCIS
Decision making
Diagnosis
Endocrine therapy
Female
Health Status
Health surveys
Humans
Interviews
LORIS
Mammography
Medical prognosis
Medical screening
Middle Aged
Participation
Patient interviews
Patient preference
Patient Selection
Patients
Personal preferences (Social sciences)
Questionnaires
Randomisation
Registration
Surgery
Trials
Womens health
Workshops
title Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study
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