학술논문
Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study
Document Type
Report
Author
Wheelwright, Sally; Matthews, Lucy; Jenkins, Valerie; May, Shirley; Rea, Daniel; Fairbrother, Pat; Gaunt, Claire; Young, Jennie; Pirrie, Sarah; Wallis, Matthew G.; Fallowfield, Lesley; Bartlett, John M. S.; Billingham, Lucinda; Bowden, Sarah; Brace-McDonnell, Samantha; Brookes, Cassandra; Cain, Henry; Dodwell, David; Evans, Andrew; Fairbrother, Patricia; Ferguson, Douglas; Francis, Adele; Hanby, Andrew; Hoar, Fiona; Holt, Simon; Kirwan, Cliona; McIntosh, Stuart; Pinder, Sarah E.; Reed, Malcolm; Roberts, Tracy; Rusby, Jennifer; Sharma, Nisha; Sibley, Pauline; Thomas, Jeremy; Wilcox, Maggie
Source
Trials. October 14, 2023, Vol. 24 Issue 1
Subject
Language
English
ISSN
1745-6215
Abstract
Author(s): Sally Wheelwright[sup.1], Lucy Matthews[sup.1], Valerie Jenkins[sup.1], Shirley May[sup.1], Daniel Rea[sup.2], Pat Fairbrother[sup.3], Claire Gaunt[sup.2], Jennie Young[sup.2], Sarah Pirrie[sup.2], Matthew G. Wallis[sup.4], Lesley Fallowfield[sup.1], John M. S. Bartlett, Lucinda Billingham, [...]
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 [greater than or equal to] 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 Keywords: DCIS, LORIS, Patient preference, Patient interviews, Trials, Randomisation
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 [greater than or equal to] 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 Keywords: DCIS, LORIS, Patient preference, Patient interviews, Trials, Randomisation