@article{nokey,

title = {Understanding the patient journey: Barriers, facilitators, and expectations in joining a chemotherapy de-escalation trial among premenopausal patients with breast cancer},

url = {https://www.sciencedirect.com/science/article/pii/S0960977626000809},

doi = { 10.1016/j.breast.2026.104770},

issn = {0960-9776},

year  = {2026},

date = {2026-03-25},

urldate = {2026-03-25},

journal = {The Breast},

volume = {87},

pages = {11},

abstract = {Background

De-escalation trials aim to balance clinical outcomes and quality of life (QoL), especially for premenopausal women with early breast cancer (BC), who often experience a greater treatment burden affecting their physical and psychosocial well-being. We sought to understand their patient journey—barriers, facilitators, and expectations—when joining de-escalation trials to inform patient-centered design and implementation.



Methods

OPTIMA-YOUNG, an EU-co-funded international trial, investigates a genomic assay-guided approach to de-escalate chemotherapy in premenopausal patients with early-stage hormone receptor (HR) + BC. A Co-creation Board of patients and healthcare professionals (HCPs) ensured stakeholder involvement throughout the trial. Focus groups (FGs) explored decision-making, needs, and QoL priorities related to joining a de-escalation clinical trial. Discussions were recorded, transcribed, anonymized, and analyzed using MAXQDA software.



Results

The three FGs included 20 participants (11 patients, 9 HCPs) from 14 countries. Three themes emerged: 1) emotional and cognitive responses to BC diagnosis/treatment; 2) environmental, HCP, and social influences on choices; 3) coping with side effects and QoL challenges. Barriers to joining a de-escalation trial included limited emotional support at diagnosis, cross-country variations in shared decision-making, poor communication on long-term side effects, fear of recurrence, and HCPs’ tendency to overtreat younger patients. Developing training for patients and HCPs was seen essential for improving communication, shared decision-making skills, and enhancing symptom management and QoL.



Conclusions

This pre-implementation study identified factors at the patient, HCP, and system levels that, if addressed, could improve the trial experience. Insights helped refine the OPTIMA-YOUNG protocol and implementation plan and may inform future de-escalation trials.

},

note = {Source: This research is part of the Path-for-Young EU-funded project.},

keywords = {Clinical Development / Trials, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Lessons learnt from developing an ethnically diverse patient and public involvement group for breast cancer research},

url = {https://bmjopen.bmj.com/content/15/3/e091888},

doi = {10.1136/bmjopen-2024-091888},

year  = {2025},

date = {2025-03-03},

urldate = {2025-03-03},

journal = {BMJ Open},

volume = {15},

abstract = {Objective: There is evidence that those who typically contribute to patient and public involvement (PPI) activities do not reflect the diversity of the population, and individuals from underserved groups are less likely to participate in healthcare research. For some researchers, understanding how to embed diversity into their PPI work can be confusing and challenging. The aim of this communication article is to reflect on our experiences and share the lessons learnt from developing an ethnically diverse PPI group to co-deliver breast cancer research.



Key points: Researchers must be realistic about timelines at both the grant application stage and during the research project, as finding contributors for inclusive and diverse PPI work takes time. Researchers will benefit from utilisation of existing expertise and resources within existing PPI teams at research institutions. It is vitally important to be clear about what researchers need in terms of contributors and what the PPI activities will be at different stages of the research project.



Conclusions: Conducting effective, diverse and meaningful PPI is a research skill that needs to be learnt and practised just like any other. Well-developed inclusive PPI has significant benefits for both researchers and the public.},

note = {Source: BMJ Open},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = { World Cafés as a participatory  approach to understanding research agendas  in primary care with underserved communities:  reflections, challenges and lessons learned},

url = {https://doi.org/10.1186/s40900-023-00509-3},

doi = {10.1186/s40900-023-00509-3},

year  = {2024},

date = {2024-07-02},

urldate = {2024-07-02},

journal = {Research Involvement and Engagement},

volume = {10},

note = {Source: BioMed Central, Springer Nature},

keywords = {Inclusion and Representativeness in Clinical Research, Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Co-creation of the Global Patient Experience Data Navigator: a multi-stakeholder initiative to ensure the patient voice is represented in health decision-making},

author = {Tom Willgoss, Omar A. Escontrias, Carole Scrafton, Elisabeth Oehrlein, Victoria Livingstone, Fiona C. Chaplin, Maddalena Benivento, Hayley Chapman & Nicholas Brooke},

url = {https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-023-00503-9},

year  = {2023},

date = {2023-10-12},

note = {Source: Published in Research Involvement and Engagement},

keywords = {Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Considerations for patient and public involvement and engagement in health research},

author = {Olalekan Lee Aiyegbusi, Christel McMullan, Sarah E. Hughes, Grace M. Turner, Anuradhaa Subramanian, Richard Hotham, Elin Haf Davies, Chris Frost, Yvonne Alder, Lisa Agyen, Lewis Buckland, Jennifer Camaradou, Amy Chong, Felicity Jeyes, Sumita Kumar, Karen L. Matthews, Patricia Moore, Jane Ormerod, Gary Price, Michael Saint-Cricq, David Stanton, Anita Walker, Shamil Haroon, Alastair K. Denniston, TLC Study Group},

url = {https://www.nature.com/articles/s41591-023-02445-x},

year  = {2023},

date = {2023-07-20},

abstract = {Patient and public involvement and engagement (PPIE) can provide valuable insights into the experiences of those living with and affected by a disease or health condition. Inclusive collaboration between patients, the public and researchers can lead to productive relationships, ensuring that health research addresses patient needs. Guidelines are available to support effective PPIE; however, evaluation of the impact of PPIE strategies in health research is limited. In this Review, we evaluate the impact of PPIE in the ‘Therapies for Long COVID in non-hospitalised individuals’ (TLC) Study, using a combination of group discussions and interviews with patient partners and researchers. We identify areas of good practice and reflect on areas for improvement. Using these insights and the results of a survey, we synthesize two checklists of considerations for PPIE, and we propose that research teams use these checklists to optimize the impact of PPIE for both patients and researchers in future studies.},

note = {Source: Published in Nature Medicine},

keywords = {Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {A systematic review of models of patient engagement in the development and life cycle management of medicines},

author = {F.I. Auwal, C. Copeland, E.J. Clark, C. Naraynassamy, G.R. McClelland},

url = {https://www.sciencedirect.com/science/article/pii/S1359644623002180?via%3Dihub},

year  = {2023},

date = {2023-07-13},

note = {Source: Elsevier},

keywords = {Patient Involvement},

pubstate = {published},

tppubtype = {article}

}

@article{nokey,

title = {Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions},

author = {Faulkner, S.D., Somers, F., Boudes, M. et al.},

url = {https://link.springer.com/article/10.1007/s40290-022-00458-4},

year  = {2023},

date = {2023-01-18},

abstract = {The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show ‘value add’ of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients’ lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.},

note = {Source: Published in Springer Link},

keywords = {Patient Involvement},

pubstate = {published},

tppubtype = {article}

}