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How can a remotely delivered, personalised physical activity intervention for people with high risk of breast, lung and bowel cancer recurrence be implemented in England? Protocol for a mixed-methods process evaluation embedded in a feasibility basket tri

Por: Jackson · G. · Pearson · M. · Bullock · A. F. · Cohen · J. · Huang · C. · Lind · M. · Saxton · J. · Wilson · C. · Twiddy · M. · Forbes · C. C.
Introduction

Randomised controlled trials (RCTs) are essential to determine intervention effectiveness yet they often fail to capture how and why interventions succeed or fail in different contexts. Embedding a process evaluation alongside a clinical trial allows exploration of implementation processes, intervention fidelity and contextual influences. The CANFit trial is a basket-design RCT evaluating a personalised, remotely delivered exercise intervention for people diagnosed with breast, lung and bowel cancer with increased risk of recurrence. This embedded process evaluation aims to understand how individual, team and organisational factors influence intervention delivery and uptake.

Methods and analysis

A concurrent, mixed-methods process evaluation will be conducted using a hybrid type 1 design. Data will be collected from multiple sources, including participant and trainer questionnaires, semi-structured interviews, intervention adherence logs, trainer diaries and observations. Five core implementation outcomes, guided by Proctor’s framework—acceptability, appropriateness, fidelity, penetration and sustainability—will structure the evaluation. Quantitative data will be analysed descriptively and qualitative data will undergo framework analysis using both deductive and inductive coding. Data integration will occur through a convergent mixed-methods approach, using context-mechanism-outcome (CMO) configurations to refine programme theory.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and the UK NHS Health Research Authority (ID: 327663). All participants will provide informed consent before taking part. Data will be handled according to General Data Protection Regulation and University of Hull data management policies. Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder reports and lay summaries for participants and the public.

Trial registration number

ISRCTN97662203.

What is known about flexible assertive community treatment across populations and contexts? A scoping review protocol

Por: Tang · F. · Evans · C. · Bogdan · A. · Bullock · H. · Westen · K. · Kroon · H. · Delespaul · P.
Introduction

The objective of this scoping review is to elucidate contexts in which Flexible Assertive Community Treatment (FACT) has been utilised, which populations it has served, how it has been adapted and what outcomes it has achieved. FACT is a model of mental healthcare where patients are transitioned along a continuum of high-intensity outreach-based treatment and lower-intensity case management, according to need. Despite being adopted globally, a review of the evidence on the FACT model has not been conducted since 2014.

Methods and analysis

This study will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A structured search of several electronic databases (MedLine, CINAHL, PsycINFO, Psychology & Behavioural Sciences, Embase, Scopus, Sociological Abstracts and ASSIA Social Sciences Index Abstracts) will be conducted to locate relevant studies addressing models of care that adhere to the core components of the FACT model and that were published in English or Dutch from 2003 (model conception date) to the present day. To explore the range of populations served by FACT, we will not limit participant populations by age or diagnosis. With respect to FACT adaptations, we will include articles that explore modifications to the structure of FACT such as staffing complement, caseloads or interface with other health and social services. Articles identified from our structured searches will be screened independently by two reviewers. Data from included articles will be extracted, analysed and presented on tables and visual graphs, and summarised in a narrative report.

Ethics and dissemination

Our scoping review does not require ethics approval as it does not involve human subjects and will draw evidence from published peer-reviewed articles. Our findings will be disseminated through journal publication, presentations at relevant conferences and distribution across our networks and those of our partners, including healthcare providers, researchers and other key stakeholders.

Phase II randomised controlled basket feasibility trial of a personalised, remotely delivered exercise programme on disease-free survival among early-stage, high-risk cancers: CANFit study protocol

Por: Bullock · A. F. · Cohen · J. · Huang · C. · Jackson · G. · Lind · M. · Pearson · M. · Richardson · G. · Saxton · J. · Twiddy · M. · Wilson · C. · Forbes · C.
Introduction

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

Methods and analysis

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

Trial registration number

ISRCTN97662203.

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