Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study.
DCIS
LORIS
Patient interviews
Patient preference
Randomisation
Trials
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
14 Oct 2023
14 Oct 2023
Historique:
received:
20
04
2023
accepted:
04
10
2023
medline:
23
10
2023
pubmed:
15
10
2023
entrez:
14
10
2023
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
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
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
BACKGROUND
ISRCTN27544579, prospectively registered on 22 May 2014.
Identifiants
pubmed: 37838682
doi: 10.1186/s13063-023-07703-4
pii: 10.1186/s13063-023-07703-4
pmc: PMC10576350
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
670Subventions
Organisme : Health Technology Assessment Programme
ID : 11/36/16
Investigateurs
John M S Bartlett
(JMS)
Lucinda Billingham
(L)
Sarah Bowden
(S)
Samantha Brace-McDonnell
(S)
Cassandra Brookes
(C)
Henry Cain
(H)
David Dodwell
(D)
Andrew Evans
(A)
Patricia Fairbrother
(P)
Douglas Ferguson
(D)
Adele Francis
(A)
Andrew Hanby
(A)
Fiona Hoar
(F)
Simon Holt
(S)
Cliona Kirwan
(C)
Stuart McIntosh
(S)
Sarah E Pinder
(SE)
Malcolm Reed
(M)
Tracy Roberts
(T)
Jennifer Rusby
(J)
Nisha Sharma
(N)
Pauline Sibley
(P)
Jeremy Thomas
(J)
Maggie Wilcox
(M)
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Grimm LJ, Rahbar H, Abdelmalak M, Hall AH, Ryser MD. Ductal carcinoma in situ: state-of-the-art review. Radiology. 2022;302(2):246–55.
doi: 10.1148/radiol.211839
pubmed: 34931856
Virnig BA, Tuttle TM, Shamliyan T, Kane RL. Ductal carcinoma in situ of the breast: a systematic review of incidence, treatment, and outcomes. J Natl Cancer Inst. 2010;102(3):170–8.
doi: 10.1093/jnci/djp482
pubmed: 20071685
NHS Breast Screening Programme, Association of Breast Surgery. An audit of screen detected breast cancers for the screening year April 2020 to March 2021. 2022.
Marmot MG, Altman DG, Cameron DA, Dewar JA, Thompson SG, Wilcox M. The benefits and harms of breast cancer screening: an independent review. Br J Cancer. 2013;108(11):2205–40.
doi: 10.1038/bjc.2013.177
pubmed: 23744281
pmcid: 3693450
Groen EJ, Elshof LE, Visser LL, Rutgers EJT, Winter-Warnars HAO, Lips EH, et al. Finding the balance between over- and under-treatment of ductal carcinoma in situ (DCIS). Breast. 2017;31:274–83.
doi: 10.1016/j.breast.2016.09.001
pubmed: 27671693
Nickel B, Moynihan R, Barratt A, Brito JP, McCaffery K. Renaming low risk conditions labelled as cancer. BMJ. 2018;362:k3322.
doi: 10.1136/bmj.k3322
pubmed: 30100549
Francis A, Fallowfield L, Rea D. The LORIS trial: addressing overtreatment of ductal carcinoma in situ. Clin Oncol (R Coll Radiol). 2015;27(1):6–8.
doi: 10.1016/j.clon.2014.09.015
pubmed: 25445552
Francis A, Thomas J, Fallowfield L, Wallis M, Bartlett JM, Brookes C, et al. Addressing overtreatment of screen detected DCIS; the LORIS trial. Eur J Cancer. 2015;51(16):2296–303.
doi: 10.1016/j.ejca.2015.07.017
pubmed: 26296293
Hwang ES, Hyslop T, Lynch T, Frank E, Pinto D, Basila D, et al. The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS). BMJ Open. 2019;9(3):e026797.
doi: 10.1136/bmjopen-2018-026797
pubmed: 30862637
pmcid: 6429899
Elshof LE, Tryfonidis K, Slaets L, van Leeuwen-Stok AE, Skinner VP, Dif N, et al. Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - the LORD study. Eur J Cancer. 2015;51(12):1497–510.
doi: 10.1016/j.ejca.2015.05.008
pubmed: 26025767
Kanbayashi C, Iwata H. Current approach and future perspective for ductal carcinoma in situ of the breast. Jpn J Clin Oncol. 2017;47(8):671–7.
doi: 10.1093/jjco/hyx059
pubmed: 28486668
pmcid: 5896693
Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82(11):1783–8.
doi: 10.1054/bjoc.2000.1142
pubmed: 10839291
pmcid: 2363224
Spielberger C. State-trait inventory for adults: sampler set, manual, test and scoring key. Redwood City: Mind Gardens; 1983.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.
doi: 10.1007/s11136-011-9903-x
pubmed: 21479777
pmcid: 3220807
Ware JE, Sherbourne CD. The Mos 36-item short-form health survey (Sf-36). 1. Conceptual-framework and item selection. Med Care. 1992;30(6):473–83.
doi: 10.1097/00005650-199206000-00002
pubmed: 1593914
Shunmugasundaram C, Rutherford C, Butow PN, Sundaresan P, Dhillon HM. What are the optimal measures to identify anxiety and depression in people diagnosed with head and neck cancer (HNC): a systematic review. J Patient Rep Outcomes. 2020;4(1):26.
doi: 10.1186/s41687-020-00189-7
pubmed: 32328839
pmcid: 7181465
Fallowfield L, Francis A, Catt S, Mackenzie M, Jenkins V. Time for a low-risk DCIS trial: harnessing public and patient involvement. Lancet Oncol. 2012;13(12):1183–5.
doi: 10.1016/S1470-2045(12)70503-X
pubmed: 23122782
Fallowfield L, Matthews L, Francis A, Jenkins V, Rea D. Low grade Ductal Carcinoma in situ (DCIS): how best to describe it? Breast. 2014;23(5):693–6.
doi: 10.1016/j.breast.2014.06.013
pubmed: 24986765
University of Birmingham Cancer Research UK Clinical Trials Unit LORIS. Available from: https://www.birmingham.ac.uk/research/activity/mds/trials/crctu/trials/loris/index.aspx . Accessed 9 Jan 2023.
Jenkins V, Farewell D, Batt L, Maughan T, Branston L, Langridge C, et al. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103(12):1801–7.
doi: 10.1038/sj.bjc.6606004
pubmed: 21119659
pmcid: 3008615
Jenkins V, Fallowfield L, Cox A. The preferences of 600 patients for different descriptions of randomisation. Br J Cancer. 2005;92(5):807–10.
doi: 10.1038/sj.bjc.6602445
pubmed: 15726098
pmcid: 2361925
Fallowfield L, Langridge C, Jenkins V. Communication skills training for breast cancer teams talking about trials. Breast. 2014;23(2):193–7.
doi: 10.1016/j.breast.2013.11.009
pubmed: 24342374
Jenkins V, Fallowfield L, Solis-Trapala I, Langridge C, Farewell V. Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. BMJ. 2005;330(7488):400.
doi: 10.1136/bmj.38366.562685.8F
pubmed: 15705666
pmcid: 549112
Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A, et al. Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020;10:MR000045.
pubmed: 33026107
Gesualdo F, Daverio M, Palazzani L, Dimitriou D, Diez-Domingo J, Fons-Martinez J, et al. Digital tools in the informed consent process: a systematic review. BMC Med Ethics. 2021;22(1):18.
doi: 10.1186/s12910-021-00585-8
pubmed: 33639926
pmcid: 7913441
DCIS precision. LORD. Available from: https://www.dcisprecision.org/clinical-trials/lord/ . Accessed 9 Jan 2023.