How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration.

BACKGROUND: Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participants' experiences, and may benefit individual studies' objectives and research in general. A group of public contributors and researchers at the Clinical Trials Research Unit, University of Leeds, aimed to develop a communication template and researcher guidance. This would address how to provide information sensitively around the time when participants stop or significantly reduce their level of participation. METHODS: The project lead used scoping review methods to identify relevant prior evidence and derive a list of potential information topics to communicate to participants who stop taking part. The topic list was reviewed by research professionals and public contributors before finalisation. Further public contributors were identified from a range of networks. The contributors formed a 'development group', to work on the detail of the planned resources, and a larger 'review group' to review the draft output before finalisation. The involvement was planned so that the development group could shape the direction and pace of the work. RESULTS: The literature review identified 413 relevant reports, resulting in 94 information topics. The review suggested that this issue has not been well explored previously. Some evidence suggested early-stopping participants are sometimes excluded from important communications (such as study results) without clear justification. The development group agreed early to focus on guidance with reusable examples rather than a template. We took time to explore different perspectives and made decisions by informal consensus. Review group feedback was broadly positive but highlighted the need to improve resource navigability, leading to its final online form. CONCLUSIONS: We co-developed a resource to provide support to research participants who stop taking part. A strength of this work is that several of the public contributors have direct lived experience of stopping research participation. We encourage others to review the resource and consider how they support these participants in their studies. Our work highlights the value of researchers and participants working together, including on complex and ethically challenging topics.

Participants in research sometimes stop taking part early. This can sometimes be stressful or difficult for them. Giving them information they want or need around that time could help them and the research. Public contributors and researchers worked together on this project. We wanted to help researchers get information to research participants who stop taking part. Some of the public contributors had experiences of stopping research participation early.The project lead first made a rough plan for the project, with public contributors' help. He left the plan open so the public contributors could help shape the project. The project lead searched for relevant information in published literature. This search showed there has not been much work before on how to help participants who stop taking part. He used the search results to make a list of topics that could be useful to give participants who stop taking part. He asked public contributors and researchers to review the list.Public contributors then joined one of two groups. A smaller group worked on the detail of the planned guidance. A larger group reviewed the draft guidance.The smaller group worked together to make the final guidance in six online meetings. The guidance includes example wording for others to use in their own participant communications. The reviewer group generally liked the guidance but had comments on making it easier to use. The final resource is available online and a link is in the references to this article.

CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer.

AIM: Excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial. METHODS: CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence. CONCLUSION: CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.

Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions.

Real-world evidence (RWE) research helps determine whether outcomes observed in clinical trials happen in real-life clinical practice. RWE research may help patients receive more appropriate treatment, closer to their needs and wishes. RWE for metastatic colorectal cancer is currently limited. The PROMETCO RWE study is an important example of an ongoing initiative that focuses on patient-reported outcomes in metastatic colorectal cancer. Patients play an active role throughout the RWE research process, including study design, participation and results dissemination. This involvement can encourage greater patient empowerment through active engagement, potentially resulting in various benefits that can lead to improved clinical outcomes. Greater patient engagement can increase involvement in RWE, helping more patients to access the benefits of RWE research. Clinical Trial Registration: NCT03935763 (ClinicalTrials.gov).

Real-world evidence (RWE) research provides information that is essential to improving medical treatment. When it comes to metastatic colorectal cancer ­ cancer that has spread to other parts of the body ­ only a few RWE studies have been conducted. RWE studies, such as the ongoing PROMETCO study in patients with metastatic colorectal cancer, differ from clinical trials in that they include a wider range of people with fewer restrictions on type of treatments received. They can also place more attention to the patients' own opinions. By joining RWE studies, patients are likely to become more interested in their disease and take a more active role in their treatment. In the end, this can help to improve their quality of life and possibly improve the outcomes of their treatment. Doctors need to work in partnership with patients to increase participation in RWE studies.

Usability of myfood24 Healthcare and Mathematical Diet Optimisation in Clinical Populations: A Pilot Feasibility Randomised Controlled Trial.

Monitoring nutritional intake is of clinical value, but few existing tools offer electronic dietary recording, instant nutritional analysis, and a platform connecting healthcare teams with patients that provides timely, personalised support. This feasibility randomised controlled trial tests the usability of 'myfood24 Healthcare', a dietary assessment app and healthcare professional website, in two clinical populations. Patients were recruited from a weight management programme (n21) and from a group of gastroenterology surgery outpatients (n = 27). They were randomised into three groups: standard care, myfood24, or myfood24 + diet optimisation (automated suggestions for dietary improvement). The participants were asked to record their diet at least four times over eight weeks. During the study, healthcare professionals viewed recorded dietary information to facilitate discussions about diet and nutritional targets. The participants provided feedback on usability and acceptability. A total of 48 patients were recruited, and 16 were randomised to each of the three groups. Compliance among app users (n = 32) was reasonable, with 25 (78%) using it at least once and 16 (50%) recording intake for four days or more. Among users, the mean (standard deviation) number of days used was 14.0 (17.5), and the median (interquartile range) was six (2.5-17.0) over 2 months. Feedback questionnaires were completed by only 23 of 46 participants (50%). The mean System Usability Score (n = 16) was 59 (95% confidence interval, 48-70). Patient and healthcare professional feedback indicates a need for more user training and the improvement of some key app features such as the food search function. This feasibility study shows that myfood24 Healthcare is acceptable for patients and healthcare professionals. These data will inform app refinements and its application in a larger clinical effectiveness trial.

SafeSpace: what is the feasibility and acceptability of a codesigned virtual reality intervention, incorporating compassionate mind training, to support people undergoing cancer treatment in a clinical setting?

OBJECTIVES: The SafeSpace study codesigned and tested a virtual reality (VR) intervention, incorporating relaxation and compassionate mind training to determine acceptability/feasibility in an oncology setting and evaluate impact on physical/psychological well-being and quality of life. DESIGN: A two-phase study. Phase I determined key characteristics using an experienced-based codesign approach. Phase II evaluated the intervention using various measures and qualitative interviews in a mixed methods approach. Descriptive statistics were used to analyse measures data and framework analysis to analyse interviews. SETTING: A specialist cancer centre, UK. PARTICIPANTS: 11 in phase I and 21 in phase II. Participants were in cancer treatment, recovery or palliative care. PRIMARY AND SECONDARY OUTCOME: Primary outcome: acceptability of the intervention, assessed by >60% uptake of three sessions. SECONDARY OUTCOMES: impact on psychological well-being using EQ-5D/QLQ-C30, Profile of Mood Scale, Warwick and Edinburgh Mental Well-being Scale, Depression and Anxiety Severity Scale 21, Self-Compassion Scale, Acceptance and Action Questionnaire and a locally developed questionnaire to capture self-compassion post use. Physiological impact was assessed by change in heart rate (HR)/HR variability and electrodermal activity (EDA). RESULTS: Twenty participants (mean age=48.7 years; SD=16.87); 65% (n=13) completed three sessions. Mental well-being improved following each use and from baseline to after session 3 (VR 1-z=2.846, p≤0.01; VR 2-z=2.501, p≤0.01; VR 3-z=2.492, p≤0.01). There was statistically significant difference in mean scores for EDA at mid-session and post session compared with pre session (F (1.658, 4.973)=13.364, p<0.05). There was statistically significant reduction in stress levels from baseline to post session 3. Participants found the intervention acceptable and highlighted areas for development. CONCLUSION: The intervention is acceptable and feasible and has shown positive effects on mental well-being/stress in the oncology setting. Larger studies are needed to confirm findings.

Chest X-ray sensitivity and lung cancer outcomes: a retrospective observational study.

BACKGROUND: Chest X-ray (CXR) is the first-line investigation for lung cancer in many healthcare systems. An understanding of the consequences of false-negative CXRs on time to diagnosis, stage, and survival is limited. AIM: To determine the sensitivity of CXR for lung cancer and to compare stage at diagnosis, time to diagnosis, and survival between those with CXR that detected, or did not detect, lung cancer. DESIGN AND SETTING: Retrospective observational study using routinely collected healthcare data. METHOD: All patients diagnosed with lung cancer in Leeds Teaching Hospitals NHS Trust during 2008-2015 who had a GP-requested CXR in the year before diagnosis were categorised based on the result of the earliest CXR performed in that period. The sensitivity of CXR was calculated and analyses were performed with respect to time to diagnosis, survival, and stage at diagnosis. RESULTS: CXR was negative for 17.7% of patients (n = 376/2129). Median time from initial CXR to diagnosis was 43 days for those with a positive CXR and 204 days for those with a negative CXR. Of those with a positive CXR, 29.8% (95% confidence interval [CI] = 27.9% to 31.8%) were diagnosed at stage I or II, compared with 33.5% (95% CI = 28.8% to 38.6%) with a negative CXR. CONCLUSION: GPs should consider lung cancer in patients with persistent symptoms even when CXR is negative. Despite longer duration to diagnosis for those with false-negative CXRs, there was no evidence of an adverse impact on stage at diagnosis or survival; however, this comparison is likely to be affected by confounding variables.