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Randomized Controlled Trial
. 2021 Nov-Dec;44(6):E687-E702.
doi: 10.1097/NCC.0000000000000995.

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)

Marika Bana  1 , Karin Ribi, Solange Peters, Susanne Kropf-Staub, Ernst Näf, Sabin Zürcher-Florin, Barbara Stoffel, Cornelia Blaeuer, Markus Borner, Diana Malin, Rebecca Biber, Daniel Betticher, Trudy Kuhn-Bächler, Nathan Cantoni, Thomas Seeger, Lukas Bütikofer, Manuela Eicher; Symptom Navi Program Group
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Free article
Randomized Controlled Trial

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)

Marika Bana et al. Cancer Nurs. 2021 Nov-Dec.
Free article

Abstract

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.

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Conflict of interest statement

S.P. has received education grants, provided consultation, attended advisory boards, and/or provided lectures for Abbvie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer-Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics, and Takeda, from whom she has received honoraria. M.E. received education grants, provided consultation, attended advisory boards, and/or provided lectures for Vifor, Roche, and Bristol-Myers Squibb. The other authors have no conflicts of interest to declare.

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