scholarly journals The Challenge of Equipoise: Qualitative Interviews Exploring the Views of Health Professionals and Women With Multiple Ipsilateral Breast Cancer in a Surgical Randomised Controlled Trial.

2021 ◽  
Author(s):  
Jenny Ingram ◽  
Lucy Beasant ◽  
John Benson ◽  
Adrian Murray Brunt ◽  
Anthony Maxwell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Trial Participation ◽  
Multidisciplinary Teams ◽  
Ipsilateral Breast ◽  
Surgical Interventions ◽  
Surgical Trial ◽  
Breast Care

Abstract BackgroundA multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.MethodsInterviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.ResultsOverarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment as ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ all played a part in whether patients agreed to take part in the trial.ConclusionsBarriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) registered 20/04/2018, https://www.isrctn.com/ISRCTN17987569; and ClinicalTrials.gov (NCT03514654).

scholarly journals The challenge of equipoise: qualitative interviews exploring the views of health professionals and women with multiple ipsilateral breast cancer in a surgical randomised controlled trial

2021 ◽  
Author(s):  
Jenny Ingram ◽  
Lucy Beasant ◽  
John Benson ◽  
Adrian Murray Brunt ◽  
Anthony Maxwell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Ipsilateral Breast ◽  
Surgical Interventions ◽  
Surgical Trial ◽  
Patient Advice ◽  
Randomised Controlled

Abstract Background. A multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer (MIBC) randomised to therapeutic mammoplasty or mastectomy, has been conducted. The MIAMI feasibility trial aimed to investigate recruitment of sufficient numbers of women to this surgical trial, however only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.Methods. Interviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.Results. Overarching themes of 1) influences on equipoise and recruitment and 2) effects of a lack of equipoise were generated. Within these themes health professional themes described the barriers to recruitment in ‘the treatment landscape has changed’; staff preferences and beliefs’ which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of ‘altruism and timing of trial approach’; ‘influences from consultants and others’; and ‘diagnostic journey doubts’ played a part in whether patients agreed to take part in the trial.Conclusions. Barriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registration numbers: ISRCTN (ISRCTN17987569) and ClinicalTrials.gov (NCT03514654).

Barriers to participation in breast cancer trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6593-6593
Author(s):  
O. Herasme ◽  
J. Goldberg ◽  
R. Sandoval ◽  
C. Harris ◽  
Y. Ortiz-Pride ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Child Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Demographic Factors ◽  
Trial Participation ◽  
Barriers To Participation ◽  
Cancer Trials

6593 Background: Clinical cancer trials allow investigators to test the effectiveness and safety of new cancer drugs and treatments. Historically, fewer that 5% of cancer patients have participated in clinical trials. The purpose of this study was to assess attitudes, beliefs, and practical barriers to clinical trial recruitment. Methods: Women were recruited in the Herbert Irving Comprehensive Cancer Center while waiting for routine breast screening or for oncology care in connection with a diagnosis of breast cancer. The 29-item survey questionnaire covered demographic factors, prior cancer diagnosis or risk factors, past experience with clinical trials if any, willingness to participate in different types of trials, and attitudinal and practical barriers to participation. Results: Of 329 respondents, 48.9% were non- Hispanic white, 10.9% non-Hispanic black, 34.9% Hispanic, and 5.30% other/unknown. The mean age of participants was 52.5 (SD=12.1). Of 131 (39.8%) participants reporting that they had been asked to participate in clinical trial, 82 were white, 17 black and 32 Hispanic. Of those who enrolled, 64 were white, 14 were black, and 19 Hispanic. Of those asked to participate 56/63 breast cancer patients (88.9%) and 44/68 others (64.7%) enrolled (P=0.002). Of 48 who reported that they had child care responsibilities, 33 enrolled (68.8) compared to 67/83 (80.7%) of those without such responsibilities (P=0.07). Of the total sample, 88/220 (40.0%) of those without childcare responsibilities but only 32/109 (29.4) said they would be willing to participate in a placebo-controlled trial. Respondents were twice as likely to say they would participate in a trial comparing two active agents as a placebo-controlled trial. Conclusion: Our findings suggest that being asked to participate in a clinical trial may be associated with demographic factors, and that specific circumstances, such as child care responsibilities, may also affect trial participation. Awareness of these barriers may help investigators to develop effective strategies for overcoming them and for improving trial participation overall. No significant financial relationships to disclose.

scholarly journals Evaluating Palin Stammering Therapy for School Children (Palin STSC 8-14): Protocol for a Feasibility Randomised Control Trial Comparing Palin STSC(8-14) with Usual Treatment

2021 ◽  
Author(s):  
Sharon K Millard ◽  
Suzanne Murphy ◽  
Garry Barton ◽  
Maria Lethersich ◽  
Lorna Rixon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Relations ◽  
School Children ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Treatment As Usual ◽  
Children And Parents ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884

scholarly journals Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial

2021 ◽  
Vol 20 ◽  
pp. 153473542097766
Author(s):  
Olivia Febvey-Combes ◽  
Elodie Jobard ◽  
Adrien Rossary ◽  
Vincent Pialoux ◽  
Aude-Marie Foucaut ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Cancer Treatment ◽  
Controlled Trial ◽  
Activity Level ◽  
Feasibility Trial ◽  
Circulating Biomarkers ◽  
Nutritional Counseling ◽  
Mixed Effect ◽  
Randomized Controlled

Purpose: Exercise has been shown to improve physical and psychological conditions during cancer therapy, but mechanisms remain poorly understood. The purpose of the present study was to report the results of cancer-related biomarkers and metabolomics outcomes from the PASAPAS feasibility study. Methods: In the PASAPAS randomized controlled trial, 61 women beginning adjuvant chemotherapy for localized breast cancer were randomized in a 6-month program of weekly aerobic exercises associated with nutritional counseling versus usual care with nutritional counseling. In the present analysis of 58 women for whom blood samples were available, first, circulating levels of biomarkers (ie, insulin, insulin-like growth factor 1, estradiol, adiponectin, leptin, interleukin-6, and tumor necrosis factor α) were measured at baseline and 6-month follow-up. Changes in biomarkers were compared between exercisers (n = 40) and controls (n = 18) using mixed-effect models. Second, serum metabolites were studied using an untargeted 1H nuclear magnetic resonance spectroscopy, and orthogonal partial least squares analyses were performed to discriminate exercisers and controls at baseline and at 6 months. Results: Over the 6-month intervention, no statistically significant differences were observed between exercisers and controls regarding changes in biomarkers and metabolomic profiles. Conclusion: The present analysis of the PASAPAS feasibility trial did not reveal any improvement in circulating biomarkers nor identified metabolic signatures in exercisers versus controls during adjuvant breast cancer treatment. Larger studies preferably in women with poor physical activity level to avoid ceiling effect, testing different doses and types of exercise on additional biological pathways, could allow to clarify the mechanisms mediating beneficial effects of physical exercise during cancer treatment. Trial registration: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1

The Kick-Smart Program: A Randomised Feasibility Trial Evaluating the Feasibility and Efficacy of a Primary-School Based Martial Arts Program Integrating Mathematics, Physical Fitness and Well-Being

2021 ◽  
Vol 9 (3) ◽  
pp. 47
Author(s):  
Louis David Burt ◽  
Nicholas Riley ◽  
Robert John Parkes ◽  
Narelle Eather
Keyword(s):  
Primary School ◽  
Martial Arts ◽  
Controlled Trial ◽  
School Setting ◽  
Well Being ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Significant Treatment ◽  
And Mathematics ◽  
Randomised Controlled

The objective of this study was to evaluate the feasibility and efficacy of the ‘Kick-Smart’ martial arts programme using a randomised controlled-trial conducted in one Australian primary school. Kick-Smart involved children 9-11yrs (n= 46) randomised into treatment or wait-list control conditions. Kick-Smart consisted of 2x60min curriculum sessions/week for 6-weeks during school hours. Positive feedback was received from students and teachers regarding program enjoyment, perceived benefits and future plans. Significant treatment effects favouring the Kick-Smart group for muscular fitness and mathematics achievement demonstrates preliminary efficacy. Findings indicate Kick-Smart is feasible for delivery in a primary school setting and effective for improving selected fitness and academic outcomes. Further evidence for the effectiveness of Kick-Smart via a larger randomised control trial is recommended.

scholarly journals Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katie Biggs ◽  
Daniel Hind ◽  
Mike Bradburn ◽  
Lizzie Swaby ◽  
Steve Brown
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Surgical Interventions ◽  
Surgical Trial ◽  
Patient Reported ◽  
Timely Fashion ◽  
Reported Data ◽  
Randomised Controlled ◽  
Recruitment Target

Abstract Background Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention. Methods Procedures and processes related to implementation of a multi-centre pragmatic surgical randomised controlled trial are discussed. In this surgical trial, forecasting of consent rates based on similar trials and micro-costing of study activities with research partners were undertaken and a video was produced targeting recruiting staff with the aim of aiding recruitment. The baseline assessments were reviewed to ensure the timing did not impact on the outcome. Attrition due to procedure waiting time was monitored and data were triangulated for the primary outcome to ensure adequate follow-up data. Results Forecasting and costing ensured that the recruitment window was of adequate length and adequate resource was available for study procedures at multiple clinics in each hospital. Recruiting staff found the recruitment video useful. The comparison of patient-reported data collected prior to randomisation and prior to treatment provided confidence in the baseline data. Knowledge of participant dropout due to delays in treatment meant we were able to increase the recruitment target in a timely fashion, and along with the triangulation of data sources, this ensured adequate follow-up of randomised participants. Conclusions This paper provides a range of evidence-based and experience-based approaches which, collectively, resulted in meeting our study objectives and from which lessons may be transferable. Trial registration ISRCTN, ISRCTN41394716. Registered on 10 May 2012. UKCRN Study ID: 12486.

scholarly journals The effect of animated consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Elizabeth Nelson ◽  
Cade Shadbolt ◽  
Samantha Bunzli ◽  
Angela Cochrane ◽  
Peter Choong ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Controlled Trial ◽  
Trial Registration ◽  
Feasibility Trial ◽  
Participant Recruitment ◽  
Surgical Trials ◽  
Written Information ◽  
Surgical Trial ◽  
Recruitment Challenges ◽  
Arthroscopic Subacromial Decompression

Abstract Background Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients’ willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved? Methods This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in. Discussion This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges. Trial registration ANZCTR, ACTRN12620001132932, date October 30, 2020

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