Cancer clinical trials – Survey evaluating patient participation and acceptance in a university-based Comprehensive Cancer Center (CCC)

Kessel, Kerstin A.; Vogel, Marco M. E.; Kessel, Carmen; Bier, H.; Biedermann, Tilo; Friess, Helmut; Herschbach, Peter; Eisenhart-Rothe, Rüdiger von; Meyer, Bernhard; Kiechle, Marion; Keller, Ulrich; Peschel, Christian; Bassermann, Florian; Schmid, Roland M.; Schwaiger, Markus; Combs, Stephanie E.

doi:10.1016/j.ctro.2018.10.001

Cited by 7 publications

(4 citation statements)

References 19 publications

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“…To address the setback of the CTN not being used to its fullest potential, pre-screening new cancer patients for clinical trial accessibility before treatment commences has been proposed. This idea has been supported by physicians in past studies [ 9 , 10 ]. Optimal procedures and additional studies will be required for moving forward with this proposal.…”

Section: Discussionmentioning

confidence: 59%

Identifying and addressing a new barrier to community-based patients accessing cancer clinical trials

Fenech,

Miklas,

Hussein

et al. 2024

Contemporary Clinical Trials Communications

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Section: Discussionmentioning

confidence: 59%

Identifying and addressing a new barrier to community-based patients accessing cancer clinical trials

Fenech,

Miklas,

Hussein

et al. 2024

Contemporary Clinical Trials Communications

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“…The Attitudes towards Clinical Trial Participation Questionnaire (ACT-Q) is a brief trial-specific questionnaire to quantify FIT-P-MND’s attitudes towards involvement in research, and multi-arm clinical trials in particular ( table 5 ). Developed by the investigators, based on Kessel’s survey 25 and Ellis’ tripartite model 17 on factors impacting trial engagement.…”

Section: Analysis Planmentioning

confidence: 99%

Prospective observational cohort study of factors influencing trial participation in people with motor neuron disease (FIT-participation-MND): a protocol

et al. 2021

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IntroductionMotor neuron disease (MND) is a rapidly progressive and fatal neurodegenerative disorder with limited treatment options. The Motor Neuron Disease Systematic Multi-Arm Randomised Adaptive Trial (MND-SMART) is a multisite UK trial seeking to address the paucity in effective disease-modifying drugs for people with MND (pwMND). Historically, neurological trials have been plagued by suboptimal recruitment and high rates of attrition. Failure to recruit and/or retain participants can cause insufficiently representative samples, terminated trials or invalid conclusions. This study investigates patient-specific factors affecting recruitment and retention of pwMND to MND-SMART. Improved understanding of these factors may improve trial protocol design, optimise recruitment and retention.Methods and analysisPwMND on the Scottish MND Register, Clinical Audit Research and Evaluation of MND (CARE-MND), will be invited to participate in a prospective observational cohort study that investigates factors affecting trial participation and attrition. We hypothesise that patient-specific factors will significantly affect trial recruitment and retention. Participants will complete the Hospital Anxiety and Depression Scale, 9-Item Patient Health Questionnaire and State-Trait Anxiety Inventory-Form Y to evaluate neuropsychiatric symptoms, the ALS-Specific Quality of Life Questionnaire-Brief Form and Centre for Disease Control and Prevention-Health-Related Quality of Life for quality of life and a novel study-specific questionnaire on Attitudes towards Clinical Trial Participation (ACT-Q). Clinical data on phenotype, cognition (Edinburgh Cognitive and Behavioural ALS Screen) and physical functioning (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) will also be collated. Caregivers will complete the Brief Dimensional Apathy Scale. After 12 months, a data request to MND-SMART will evaluate recruitment and retention. Descriptive statistics will summarise and compare assessments and participants reaching impairment thresholds. Variable groupings: attitudes, quality of life, cognition, behaviour, physical functioning, neuropsychiatric and phenotype. Univariate and multivariable logistic regression will explore association with participation/withdrawal in MND-SMART; presented as ORs and 95% CIs.Ethics and disseminationEthical approval was provided by the West of Scotland Research Ethics Committee 3 (20/WS/0067) on 12 May 2020. The results of this study will be published in a peer-reviewed journal, presented at academic conferences and disseminated to participants and the public.

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“…There are few successful examples of substantive patient contribution to clinical trial design and process, especially while actively participating in the trial [ 7 , 8 ]. Those instruments that do exist to evaluate participant feedback have generally only been developed and evaluated in a specific trial design or for implementation in one indication [ 9 ]. Therefore, there is an unmet need for an instrument that could comprehensively evaluate participant experience in a variety of clinical trials globally, across a range of therapeutic indications, among diverse populations, and at key points throughout a clinical trial [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)

Greene

Elmer

Ludlam

et al. 2020

Ther Innov Regul Sci

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Objectives The Study Participant Feedback Questionnaire (SPFQ) is a patient-completed tool designed to assess patient experiences and satisfaction with aspects associated with being involved in a clinical trial. Originally developed in oncology and among English-speaking participants, the aim of the current study was to evaluate the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries. Methods Semi-structured qualitative telephone interviews were conducted with 80 participants across eight non-Englishspeaking countries (in Europe, South America and Asia) who had received an investigational medicinal product as part of a clinical trial in the past three years. Interviews comprised concept elicitation to identify concepts of importance to participants' trial experiences, and cognitive debriefing to assess understanding and perceived importance of SPFQ instructions, items and response options. Results Concept elicitation findings supported the content validity of the SPFQ. During cognitive debriefing, SPFQ instructions and the majority of items were well understood by participants. Participants generally considered the SPFQ items important to their clinical trial experience, albeit a handful of items assessed concepts that had not been experienced by trial participants or were redundant with other SPFQ items. The instructions, response options and recall period of the SPFQ were generally well understood. No country-level differences in understanding or importance were apparent. Conclusion Study findings provide evidence for the content and cross-cultural validity of the SPFQ and support implementation of the SPFQ as a means of obtaining participant feedback across global development programmes in a variety of indications.

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Cancer clinical trials – Survey evaluating patient participation and acceptance in a university-based Comprehensive Cancer Center (CCC)

Cited by 7 publications

References 19 publications

Identifying and addressing a new barrier to community-based patients accessing cancer clinical trials

Identifying and addressing a new barrier to community-based patients accessing cancer clinical trials

Prospective observational cohort study of factors influencing trial participation in people with motor neuron disease (FIT-participation-MND): a protocol

Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)

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