Implementation of the Symptom Navi © Programme for cancer patients in the Swiss outpatient setting: a study protocol for a cluster randomised pilot study (Symptom Navi© Pilot Study)

Bana, Marika; Ribi, Karin; Kropf-Staub, Susanne; Zürcher-Florin, Sabin; Näf, Ernst; Manser, Tanja; Bütikofer, Lukas; Peters, Solange; Eicher, Manuela

doi:10.1136/bmjopen-2018-027942

Cited by 5 publications

(15 citation statements)

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“…Assuming an intraclass correlation of 0.05 and a type I error rate of 5%, 9 clusters with 15 patients (ie, n = 135 patients) would allow the authors to detect effect sizes of 0.5, 0.75, and 1.0 with a power of 60%, 91%, and 99%, respectively. 23 Wilcoxon-Mann-Whitney and Fisher exact tests were used to compare continuous and categorical patient baseline characteristics as appropriate. We used intention-to-treat approach for primary analysis (ie, all patients at randomized clusters were included in the analyses).…”

Section: Methodsmentioning

confidence: 99%

“…22 The SNP complements usual nursing care and consists of written information leaflets called Symptom Navi Flyers (SN-Flyers), nurse-led semistructured consultations using the SN-Flyers, and a training manual to standardize SNP implementation. 23 Best practices recommend testing feasibility and effectiveness of complex interventions, like the SNP, prior to widespread implementation. 24 We conducted a multimethod pilot study (Symptom Navi Pilot Study) to evaluate the implementation process (the study protocol has been previously published 23 ).…”

Section: E688mentioning

confidence: 99%

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Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment

et al. 2021

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Behavior change Implementation researchNurse-led interventions Self-efficacySelf-management support Symptom managementBackground: 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.

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Section: Methodsmentioning

confidence: 99%

Section: E688mentioning

confidence: 99%

Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment

et al. 2021

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“…Herein, we provide a comprehensive overview of the development of the Symptom Navi© Pilot Study (NCT03649984) and evaluation of the nurse training program. An ongoing two-arm cluster-randomised study (complemented with qualitative methods) is underway to assess feasibility and determine preliminary effectiveness of the SN©P (approved by cantonal Swiss ethic committee, KEK-BE: 2017-00020) (Bana et al, 2019).…”

Section: Methodsmentioning

confidence: 99%

“…Subsequently, SN©Flyers were refined (Version 2.0) based the online survey results and focus group discussion. The final SN©Flyers version included 16 symptom-specific flyers (three flyers were added to the first version) (Bana et al, 2019).…”

Section: Evaluation Ofmentioning

confidence: 99%

Development and implementation strategies of a nurse-led symptom self-management program in outpatient cancer centres: The Symptom Navi© Programme

Bana

Ribi

Kropf-Staub³

et al. 2020

European Journal of Oncology Nursing

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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. Methods: 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. Results: 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). Conclusions: 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. Clinical trial registry: NCT03649984 and SNCTP000002381.

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“…According to the data of the Leukemia and Lymphoma Society, 85,720 new lymphoma cases were diagnosed in the USA in 2020, and 20,910 deaths were expected in the same year due to this disease (Leukemia & Lymphoma Society, 2020). For this reason, supporting patients with lymphoma with education for negative and chronic conditions using web-based interventions and empowering them in disease management by changing their negative thoughts and feelings is important in terms of the health of the individual and society (Arts et al, 2017;Bana et al, 2019;Børøsund et al, 2014;van der Hout et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

The effect of web‐based intervention programs on self‐management and symptom management in patients with lymphoma: A systematic review of randomized controlled trials

Sezgi̇n

Bektaş

2021

Japan Journal Nursing Sci

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Aim This systematic review aimed to systematically summarize studies obtained through a database search and examine the effect of web‐based intervention programs on self‐management and symptom management in patients with lymphoma. Methods A systematic review of randomized controlled trials was carried out. Cochrane Central Register of Controlled Trials, Web of Science, PubMed, CINAHL, Scopus, ProQuest, Science Direct, and Ovid databases were reviewed until January 2021. The flow chart of the Preferred Reporting Items for Systematic Review and Meta‐Analysis checklist was used in the search procedure without setting a year limit. Population, Intervention, Comparison, Outcomes and Study criteria were determined by two independent investigators and published randomized controlled studies in English with lymphoma diagnosis and web‐based intervention programs for self‐management and symptom management were included in the systematic review. The included studies were examined for their risk of bias with the help of the Cochrane Collaboration tool. A narrative synthesis of study findings was performed. Results Six randomized controlled trials with 2382 participants were included in the systematic review. Web‐based intervention programs in patients diagnosed with lymphoma were found to be generally implemented for determining the levels of self‐management and symptom management. In all of the studies reviewed, it was found that the interventions had treatment outcomes. The risk of Bias 2 was evaluated as high risk in two studies that did not meet the criteria for blinding outcome evaluations. The included studies, while evaluating the effects of web‐based intervention programs on patient outcomes, could not provide information about the underlying mechanisms by which these effects occur and how they occur. Conclusions All of the studies included were found to apply a technology designed to improve outcomes in patients with lymphoma. It is recommended that web‐based intervention programs be individualized by adapting them to lymphoma types and stages, and serve as a guide for effective symptom management.

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Implementation of the Symptom Navi © Programme for cancer patients in the Swiss outpatient setting: a study protocol for a cluster randomised pilot study (Symptom Navi© Pilot Study)

Cited by 5 publications

References 58 publications

Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment

Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment

Development and implementation strategies of a nurse-led symptom self-management program in outpatient cancer centres: The Symptom Navi© Programme

The effect of web‐based intervention programs on self‐management and symptom management in patients with lymphoma: A systematic review of randomized controlled trials

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