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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)

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Oncology
Protocol
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)
  1. Marika Bana1,2,
  2. Karin Ribi2,3,
  3. Susanne Kropf-Staub4,
  4. Sabin Zürcher-Florin4,
  5. Ernst Näf5,
  6. Tanja Manser6,
  7. Lukas Bütikofer7,
  8. Felix Rintelen7,
  9. Solange Peters8,
  10. Manuela Eicher2,8
  1. 1 HedS-FR School of Health Sciences, University of Applied Science and Arts Western Switzerland, Fribourg, Switzerland
  2. 2 IUFRS Institut de formation et de recherche en soins, Université de Lausanne Faculté de biologie et médecine, Lausanne, Switzerland
  3. 3 Quality ofLife Office, International Breast Cancer Study Group, Bern, Switzerland
  4. 4 Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland
  5. 5 Department of Practice Development in Nursing, Solothurner Spitaler AG, Solothurn, Switzerland
  6. 6 FHNW School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Olten, Switzerland
  7. 7 CTU, Universität Bern, Bern, Switzerland
  8. 8 Departement of Oncology, CHUV, Lausanne, Switzerland
  1. Correspondence to Dr Manuela Eicher; manuela.eicher{at}chuv.ch

Abstract

Introduction Self-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 analysis This 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 dissemination The 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 number NCT03649984; Pre-results.

  • self-efficacy
  • RE-AIM framework
  • symptom self-management
  • Nurses/nursing
  • implementation research

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-027942

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    Footnotes

    • Contributors MB: SN©P development, study design and conduct, manuscript writing. KR: study conduct, manuscript writing. SK-S and EN: SN©P development, study design and conduct, manuscript review. SZ-F: SN©P development, study design, manuscript review. TM and SP: study design, manuscript review. LB and FR: study design and statistical support, manuscript review. ME: SN©P development, study design and conduct, obtained funding, manuscript writing.

    • Funding This study is funded by: University of Applied Sciences and Arts Western Switzerland, School of Health Sciences Fribourg, Switzerland; Institute of Higher Education and Research in Health Care, Faculty of Biology and Medicine, University of Lausanne, Switzerland; Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; Hospital Group Lindenhof, Bern, Switzerland; Swiss Cancer League, Bern, Switzerland; Dr Hans Altschüler Stiftung, St Gallen, Switzerland.

    • Disclaimer The Swiss Cancer League and Dr Hans Altschüler Stiftung provided financial support for reimbursement of participating cancer outpatient centres and for the Clinical Trial Unit. None of these bodies were involved in the study design or writing the manuscript, nor will they be involved in analysis and interpretation of the results of this pilot study.

    • Competing interests SP has received education grants, provided consultation, attended advisory boards and/or provided lectures for: Abbvie, Amgen, AstraZeneca, Bayer, Biocartis, BoehringerIngelheim, 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. ME received education grants, provided consultation, attended advisory boards and/or provided lectures for: Vifor, Roche, and Bristol-Myers Squibb. All other authors have no competing interests to declare.

    • Provenance and peer review Not commissioned; externally peer reviewed.