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BACKGROUND The Symptom Navi Program (SNP) is a nurse-led intervention supporting basic symptom self-management for patients with any cancer diagnosis. The SNP has been accepted by patients and healthcare professionals alike. OBJECTIVE The aims of this study were to pilot the SNP and evaluate patient-reported symptom outcomes, nursing support for symptom management, and patient safety. METHODS Using a cluster-randomized design, we randomized centers to the intervention (SNP) or control group (usual care). Adult patients starting first-line systemic cancer treatment were included. The primary outcome was the change in symptom interference with daily functions from treatment onset to 16 weeks. Secondary outcomes included changes in symptom severity, symptom burden, self-efficacy, and perceived symptom management support and patient safety. We used linear and logistic mixed-effects models to pilot-test differences in mean changes between groups. The trial was registered with ClinicalTrials.gov (NCT03649984). RESULTS Changes in symptom interference with daily functions did not differ (mean difference at 16 weeks: -0.50; 95% confidence interval, -1.38 to 0.38; P = 0.25) between SNP (3 centers, 49 patients) and control (5 centers, 85 patients) as for all other outcomes. No adverse events were reported. CONCLUSIONS Our preliminary findings did not indicate an effect of the SNP on patient-reported symptom outcomes, self-efficacy, or symptom management support. Inadequate power and SNP components (eg, insufficient training, low number of follow-up consultations) may be attributed to the lack of an observed effect. IMPLICATIONS FOR PRACTICE The SNP training content and intervention procedures merit reconsideration.

IntroductionSelf-management interventions show promising results on symptom outcomes and self-management behaviours. The Symptom Navi© Programme (SN©P) is a nurse-led intervention supporting patients’ symptom self-management during anticancer treatment. It consists of written patient information (Symptom Navi© Flyers (SN©Flyers)), semistructured consultations and a training manual for nurses.Methods and analysisThis pilot study will evaluate the implementation of the SN©P based on the Reach Effectiveness—Adoption Implementation Maintenance framework at Swiss outpatient cancer centres. We will use a cluster-randomised design and randomise the nine participating centres to the intervention or usual care group. We expect to include 140 adult cancer patients receiving first-line systemic anticancer treatment. Trained nurses at the intervention clusters will provide at least two semistructured consultations with the involvement of SN©Flyers. Outcomes include patients’ accrual and retention rates, patient-reported interference of symptoms with daily functions, symptom burden, perceived self-efficacy, quality of nursing care, nurse-reported facilitators and barriers of adopting the programme, nurses’ fidelity of providing the intervention as intended, and patients’ safety (patients timely reporting of severe symptoms). We will use validated questionnaires for patient-reported outcomes, focus group interviews with nurses and individual interviews with oncologists. Linear mixed models will be used to analyse patient-reported outcomes. Focus group and individual interviews will be analysed by thematic analysis.Ethics and disseminationThe Symptom Navi© Pilot Study has been reviewed and approved by Swiss Ethic Committee Bern (KEK-BE: 2017–00020). Results of the study will be disseminated in peer-reviewed journal and at scientific conferences.Trial registration numberNCT03649984; Pre-results.

The Symptom Navi© Programme (SN©P) is a structured nurse-led intervention supporting symptom self-management in cancer patients. We describe the development and evaluation of the intervention, implementation strategy, and the evaluation of nurse training for the Symptom Navi© Pilot Study. The intervention was developed using multiple methods (e.g. literature synthesis, focus groups) to produce SN©P information leaflets (SN©Flyers in French and German) and standardised training for nurses to deliver semi-structured consultations. We evaluated the SN©P using online surveys, focus groups, interviews, and the Item-Content Validity Index (I-CVI). Nurse training was evaluated in relation to content, acceptability, and confidence in implementing the SN©P. We examined the association between scored on the Work-related Sense of Coherence (Work-SoC) scale and nurses' confidence in implementing the SN©P. Thematic analysis was used to analyse qualitative data. Quantitative data was descriptively analysed and the Kendall Tau test was employed for correlations. Patients and health care professionals confirmed that SN©Flyers and semi-structured consultations facilitated symptom self-management. Nurses considered training content/format acceptable and appropriate and felt confident in implementing the SN©P. Overall Work-SoC scores were correlated with nurses' confidence in implementing the SN©P (r π = .47, p = .04). Health care professionals and cancer patients perceived the SN©P as a useful support. Successful implementation of the SN©P depends on centre-specific factors including time, resources and workflow. NCT03649984 and SNCTP000002381.