Supporting Trial Participation in People with the Huntington's Gene: A Patient-Centered, Theory-Guided Survey of Barriers and Enablers.

Background: Under-recruitment regularly impedes clinical trials, leading to wasted resources and opportunity costs. Methods for designing trial participation strategies rarely consider behavior change theory.

Objective: Informed by the Theoretical Domains Framework, we identified factors important to participating in Huntington's disease research and provide examples of how such a theory-informed approach can make specific suggestions about how to design targeted recruitment strategies.

Building Capacity for Patient-Oriented Research: Utilizing Decision Aids to Translate Evidence into Practice, Policy and Outcomes.

Background: The aim of this project was to engage with patient partners to translate knowledge about the decision aids and develop a scaling-up strategy for wider effects and reach.

Method: This project was guided by the World Health Organization and IDEAS (Integrate, Design, Assess and Share) frameworks for design thinking (e.g.

Report from the Ready for the Next Round Thought-Leadership Roundtables on Building Resilience in Cancer Care and Control in Canada-Colorectal Cancer Canada; 2021.

(1) Background: The COVID-19 pandemic illuminated vulnerabilities in the Canadian health care system and exposed gaps and challenges across the cancer care continuum. Canada is experiencing significant disruptions to cancer-related services, and the impact these disruptions (delays/deferrals/cancellations) have on the health care system and patients are yet to be determined. Given the potential adverse ramifications, how can Canada's health care systems build resilience for future threats? (2) Methods: To answer this question, CCC facilitated a series of four thought-leadership roundtables, each representing the views of four different stakeholder groups: patients, physicians, health care system leaders, and researchers.

Patient engagement partnerships in clinical trials (PEP-CT): protocol for the systematic development and testing of patient partner and investigator decision aids.

Introduction: Building capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials.

Methods And Analysis: Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing.

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

Background: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial.

A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation.

Objectives: Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little empirically supported guidance for trialists seeking to optimize their trial recruitment strategies. We propose that the challenges of recruitment can be better understood and addressed by thinking of research participation as one or more behaviors, subject to the same forces as other human behaviors. In this article, we describe an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation.

Patient Engagement Partnerships in Clinical Trials: Development of Patient Partner and Investigator Decision Aids.

Background: A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research.

Objectives: The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials.

Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.

Background: Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture.

Survey of Awareness and Perceptions of Canadians on the Benefits and Risks of Clinical Trials.

Background: Little is known about the Canadian public's perspective regarding clinical trials.

Methods: We surveyed 1602 Ontario and British Columbia residents to ascertain their understanding of and willingness to participate in clinical trials.

Results: Clinical trials are regarded positively with overall perceptions that they provide societal and personal benefits.

Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol.

Background: There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resources from governments worldwide for patient-centered research, have created an unprecedented opportunity to advance the conduct of pragmatic trials, which can ultimately improve patient health and health system outcomes. Such trials raise ethical issues that have not yet been fully addressed, with existing literature concentrating on regulations in specific jurisdictions rather than arguments grounded in ethical principles.

Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16.

Purpose: We conducted a multicenter, randomized trial to compare progression-free survival (PFS), overall survival (OS), and quality of life in women with metastatic breast cancer (MBC) receiving high-dose chemotherapy plus autologous stem-cell transplantation (ASCT; HDCT) compared with standard-dose therapy.

Patient And Methods: Between April 1997 and December 2000, 386 women with MBC and no prior chemotherapy for metastatic disease were registered. After initial response to anthracycline- or taxane-based induction chemotherapy, 224 patients were randomly assigned: 112 to high-dose cyclophosphamide, mitoxantrone, and carboplatin chemotherapy and ASCT (HDCT), and 112 to standard therapy (ST).

Phase III study of N,N-diethyl-2-[4-(phenylmethyl) phenoxy]ethanamine (BMS-217380-01) combined with doxorubicin versus doxorubicin alone in metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group Study MA.19.

Purpose: N,N-diethyl-2-[4-(phenylmethyl)phenoxy]ethanamine (DPPE; tesmilifene) is a novel agent that augments chemotherapy cytotoxicity in vitro and in vivo. A phase II trial combining DPPE and doxorubicin (DOX) in metastatic breast carcinoma showed increased response over that expected with DOX. We report a phase III trial comparing DOX with DPPE plus DOX in metastatic or recurrent breast cancer.