Protocol for a pilot and feasibility study evaluating a complex nurse-led patient education intervention to promote cancer patient engagement in healthy lifestyle (O-PHE programme)

IntroductionLiterature suggests that patient engagement in healthy lifestyle is of crucial importance in ensuring a more effective management of side effects of cancer therapies and better quality of life for patients. While many studies describe educational interventions to promote healthy lifestyles, few are focused on promoting active patient engagement in this field. This protocol paper outlines a study to determine the feasibility of a complex nurse-led patient education intervention aimed to promote cancer patient engagement in a healthy lifestyle.Method and analysisThis is a randomised pilot and feasibility study. Research nurses will recruit 40 adult patients newly diagnosed with cancer. Consenting participants will be randomised to undergo the patient engagement in healthy lifestyle intervention or the control group by means of a four-block randomisation procedure. The intervention will be delivered by a clinical nurse trained in patient engagement strategies. The primary outcome will be a description of study feasibility (recruitment and retention rates, protocol adherence and stakeholder acceptability). Secondary outcomes include changes between and within groups in healthy lifestyle behaviours (ie, increase in healthy diet, smoke cessation or reduction, increase in physical activity), in quality-of-life rates after the intervention, in patient engagement levels, in the perception of the quality of care, in nutritional status; the number of recurrences or the onset of new cancer diagnosis; the number of hospitalization.Ethics and disseminationThe study protocol has been approved by the Canton Ticino Ethical Committee (Protocol ID: 2020-02477 TI). The results will be published in peer-reviewed journals and will be presented at national and international congresses. Finally, patients' organisations, such as the Swiss Cancer League, will be involved in the dissemination process. This study will inform the decision to proceed with a randomised controlled trial to assess the effect of this intervention.

Automated summary

This study aims to determine the feasibility of a complex nurse-led patient education intervention to promote cancer patient engagement in a healthy lifestyle. The intervention will be delivered by a trained clinical nurse, and the primary outcome measures include recruitment and retention rates, protocol adherence, and stakeholder acceptability. Secondary outcome measures include changes in healthy lifestyle behaviors, quality of life ratings, patient engagement levels, perception of care quality, nutritional status, recurrence or onset of new cancer diagnosis, and hospitalization rates.