Format

Send to

Choose Destination
BMJ Open. 2019 Jul 9;9(7):e027942. doi: 10.1136/bmjopen-2018-027942.

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).

Author information

1
HedS-FR School of Health Sciences, University of Applied Science and Arts Western Switzerland, Fribourg, Switzerland.
2
IUFRS Institut de formation et de recherche en soins, Université de Lausanne Faculté de biologie et médecine, Lausanne, Switzerland.
3
Quality ofLife Office, International Breast Cancer Study Group, Bern, Switzerland.
4
Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland.
5
Department of Practice Development in Nursing, Solothurner Spitaler AG, Solothurn, Switzerland.
6
FHNW School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Olten, Switzerland.
7
CTU, Universität Bern, Bern, Switzerland.
8
Departement of Oncology, CHUV, Lausanne, Switzerland.

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.

KEYWORDS:

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

Conflict of interest statement

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.

Supplemental Content

Full text links

Icon for HighWire Icon for PubMed Central
Loading ...
Support Center