Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them

Brehaut, Jamie; Carroll, Kelly; Gordon, Jenn; Presseau, Justin; Richards, Dawn P.; Fergusson, Dean; Graham, Ian D.; Marlin, Susan

doi:10.3390/curroncol28030187

Cited by 4 publications

(3 citation statements)

References 25 publications

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“…There are emerging examples in the literature of (components of) similar behavioural approaches being used to target trial recruitment to diagnose the problem but also some that extend to the development of theory-informed interventions, in this case targeting urologists to recruit from underserved populations in oncology [ 22 – 25 ]. Encouraging other trial teams to conceptualise trial problems as behaviours and develop behaviour change interventions targeting trial retention will allow the generation of a cumulative evidence base.…”

Section: Discussionmentioning

confidence: 99%

The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials

Newlands

Duncan

Treweek

et al. 2022

Trials

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Background A failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. Methods This study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire. Results Eight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable. Conclusions This is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.

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Section: Discussionmentioning

confidence: 99%

The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials

Newlands

Duncan

Treweek

et al. 2022

Trials

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“…One influence on people's decision to participate in research is the social influence of trust relationships. Family and friends, for example, can have a strong influence on the decision to participate [28,29]. The trust participants have in researchers or institutions (e.g., a university or hospital) may also be a reason to participate [30][31][32], while distrust in pharmaceutical companies has been connected to a decreased willingness to participate in their trials [33].…”

Section: Is It Ethical To Leverage Trust Relationships?mentioning

confidence: 99%

Changing patient preferences toward better trial recruitment: an ethical analysis

Hey

Weijer

et al. 2023

Trials

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While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of behavioral influences during recruitment is in tension with the ethical principle of respect for persons, as at least some of these influences could be used to manipulate potential participants. In this paper, we examine this tension by discussing two types of behavioral influences: one example involves physician recommendations, and the other involves framing of information to exploit cognitive biases. We argue that despite the apparent tension with ethical principles, influencing trial participants through behavior change strategies can be ethically acceptable. However, we argue that trialists have a positive obligation to analyze their recruitment strategies for behavioral influences and disclose these upfront to the research ethics committee. But we also acknowledge that since neither trialists nor ethics committees are presently well equipped to perform these analyses, additional resources and guidance are needed. We close by outlining a path toward the development of such guidance.

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“…There are emerging examples in the literature of (components of) similar behavioural approaches being used to target trial recruitment to diagnose the problem but also some that extend to the development of theory-informed interventions, in this case targeting urologists to recruit from underserved populations in oncology [19][20][21][22]. Encouraging other trial teams to conceptualise trial problems as behaviours and develop behaviour change interventions targeting trial retention will allow the generation of a cumulative evidence base.…”

Section: Goal-setting To Improve Questionnaire Returnmentioning

confidence: 99%

The Development of Theory-Informed Participant-Centred Interventions to Maximise Participant Retention in Randomised Controlled Trials

Newlands

Duncan

Treweek

et al. 2021

Preprint

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BackgroundA failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention. MethodsThis study used a multi-phase sequential mixed methods approach informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions based on participant accounts were described and developed in a co-design workshop with trial participants. We then assessed acceptability and feasibility of two of the prioritised retention interventions during a focus group, which also included a questionnaire, involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). ResultsEight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed based on suggestions provided by trial participants: 1. Incentives and rewards for follow-up clinic attendance; 2. Goal setting for improving questionnaire return; 3. Self-monitoring to improve questionnaire return and/or clinic attendance; and 4. Motivational information to improve questionnaire return and clinic attendance. Seventeen trial stakeholders (participants, trialists, ethics committee members) contributed to the evaluation of acceptability and feasibility of the retention interventions, which were generally positive with some areas for consideration highlighted. ConclusionsThis is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess their effectiveness and assess resource implications.

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Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them

Cited by 4 publications

References 25 publications

The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials

The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials

Changing patient preferences toward better trial recruitment: an ethical analysis

The Development of Theory-Informed Participant-Centred Interventions to Maximise Participant Retention in Randomised Controlled Trials

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