Abstract

Introduction We designed a randomized controlled trial with a complex intervention where nurse-navigators in whole cancer trajectories address healthcare sectorial gaps and act as integration hubs for psychosocial care from healthcare- and social systems. How could we refine the intervention and measure the primary outcome?MethodsBased on literature search and discussions among clinician-scientists, ideas of effect types were specified and outcomes selected, notably self-efficacy. Bandura’s theory of self-efficacy states: your judgement of own ability to meet challenges increase, if you or a known another has overcome similar situations, if you have relevant knowledge, and/or significant others trust your abilities(1). Discussions with lay-persons allowed us to transform the theory to actions, and pilot-audit it.ResultsThe navigators must screen for self-efficacy and act upon results within the frame of navigation(2,3). If, for instance, a person is afraid to die of cancer, the navigator must take this as point of departure: examine the patient’s knowledge and experienced similar situations, and from here educate and point out potentially useful resources for the patient. Pilot audits showed, that the intervention can be refined in clarifying the role of navigators and delivered as intended. A validated questionnaire of self-efficacy for cancer was chosen(4) and should be analyzed as group differences in change, from enrolment in a “possible-cancer-trajectory” to “end-of-cancer-treatment”.Discussion If patients in the intervention arm do better regarding self-efficacy than those receiving standard care, our complex intervention contributes to Integrated Care. In this case, the above described attitude in connecting patients to relevant psychosocial support opportunities whoever offers them will be recommended. However, the same continuously available nurse navigator throughout cancer trajectories might foster her as a significant other to the patient(5), and when signalling trust in the patient’s ability to act, the nurse navigator, as such, might support patient experienced self-efficacy. Therefore, this construct will be recommended as well.Conclusion Designing a coherent theoretical basis-intervention, involving people and piloting helped to refine the complex intervention and confirmed the relevance of self-efficacy as primary outcome.Lessons learnedBreaking down theories underlying wishes for effect, makes it possible to refine a complex intervention and audit it.LimitationsSelf-efficacy is a part of a larger complex intervention on Danes.Suggestions for future researchMore focus on reporting theories underlying complex interventions is needed.

Highlights

  • We designed a randomized controlled trial with a complex intervention where nurse-navigators in whole cancer trajectories address healthcare sectorial gaps and act as integration hubs for psychosocial care from healthcare- and social systems

  • For instance, a person is afraid to die of cancer, the navigator must take this as point of departure: examine the patient’s knowledge and experienced similar situations, and from here educate and point out potentially useful resources for the patient

  • If patients in the intervention arm do better regarding self-efficacy than those receiving standard care, our complex intervention contributes to Integrated Care

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Summary

Introduction

How could we refine the intervention and measure the primary outcome?

Methods
Results
Discussion
Conclusion
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