Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment: A Cluster-Randomized Study (Symptom Navi Pilot Study).

Bana, Marika; Ribi, Karin; Peters, Solange; Kropf-Staub, Susanne; Zürcher-Florin, Sabin; Näf, Ernst; Stoffel, Barbara; Blaeuer, Cornelia; Borner, Markus; Malin, Diana; Biber, Rebecca; Betticher, Daniel; Kuhn-Bächler, Trudy; Cantoni, Nathan; Seeger, Thomas; Bütikofer, Lukas; Eicher, Manuela (2021). Pilot Testing of a Nurse-Led Basic Symptom Self-management Support for Patients Receiving First-Line Systemic Outpatient Anticancer Treatment: A Cluster-Randomized Study (Symptom Navi Pilot Study). Cancer nursing, 44(6), E687-E702. Wolters Kluwer 10.1097/NCC.0000000000000995

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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.

Interest & Impact

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