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Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study
BACKGROUND: 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 bo...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576350/ https://www.ncbi.nlm.nih.gov/pubmed/37838682 http://dx.doi.org/10.1186/s13063-023-07703-4 |
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author | Wheelwright, Sally Matthews, Lucy Jenkins, Valerie May, Shirley Rea, Daniel Fairbrother, Pat Gaunt, Claire Young, Jennie Pirrie, Sarah Wallis, Matthew G. Fallowfield, Lesley |
author_facet | Wheelwright, Sally Matthews, Lucy Jenkins, Valerie May, Shirley Rea, Daniel Fairbrother, Pat Gaunt, Claire Young, Jennie Pirrie, Sarah Wallis, Matthew G. Fallowfield, Lesley |
author_sort | Wheelwright, Sally |
collection | PubMed |
description | BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN27544579, prospectively registered on 22 May 2014 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07703-4. |
format | Online Article Text |
id | pubmed-10576350 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-105763502023-10-15 Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study Wheelwright, Sally Matthews, Lucy Jenkins, Valerie May, Shirley Rea, Daniel Fairbrother, Pat Gaunt, Claire Young, Jennie Pirrie, Sarah Wallis, Matthew G. Fallowfield, Lesley Trials Research BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN27544579, prospectively registered on 22 May 2014 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07703-4. BioMed Central 2023-10-14 /pmc/articles/PMC10576350/ /pubmed/37838682 http://dx.doi.org/10.1186/s13063-023-07703-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Wheelwright, Sally Matthews, Lucy Jenkins, Valerie May, Shirley Rea, Daniel Fairbrother, Pat Gaunt, Claire Young, Jennie Pirrie, Sarah Wallis, Matthew G. Fallowfield, Lesley Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title | Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title_full | Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title_fullStr | Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title_full_unstemmed | Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title_short | Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study |
title_sort | recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the loris study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576350/ https://www.ncbi.nlm.nih.gov/pubmed/37838682 http://dx.doi.org/10.1186/s13063-023-07703-4 |
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