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)

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 (S...

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Main Authors: Marika Bana, Karin Ribi, Susanne Kropf-Staub, Sabin Zürcher-Florin, Ernst Näf, Tanja Manser, Lukas Bütikofer, Solange Peters, Manuela Eicher
Format: Article
Language:English
Published: BMJ Publishing Group 2019-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/7/e027942.full
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author Marika Bana
Karin Ribi
Susanne Kropf-Staub
Sabin Zürcher-Florin
Ernst Näf
Tanja Manser
Lukas Bütikofer
Solange Peters
Manuela Eicher
author_facet Marika Bana
Karin Ribi
Susanne Kropf-Staub
Sabin Zürcher-Florin
Ernst Näf
Tanja Manser
Lukas Bütikofer
Solange Peters
Manuela Eicher
author_sort Marika Bana
collection DOAJ
description 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.
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spelling doaj-art-ea31c9b44a6a45ccbc4a434e720d0a722024-11-28T20:05:12ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-027942Implementation 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)Marika Bana0Karin Ribi1Susanne Kropf-Staub2Sabin Zürcher-Florin3Ernst Näf4Tanja Manser5Lukas Bütikofer6Solange Peters7Manuela Eicher81 HedS-FR School of Health Sciences, University of Applied Science and Arts Western Switzerland, Fribourg, Switzerland1 Careum School of Health, part of the Kalaidos University of Applied Sciences, Zurich, Switzerland4 Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland4 Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland5 Department of Practice Development in Nursing, Solothurner Spitaler AG, Solothurn, Switzerland3 FHNW School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Olten, SwitzerlandCTU Bern, University of Bern, Bern, SwitzerlandDepartment of Oncology CHUV-UNIL, University Hospital Lausanne, Lausanne, SwitzerlandDepartment of Oncology, Lausanne University Hospital, Lausanne, SwitzerlandIntroduction 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.https://bmjopen.bmj.com/content/9/7/e027942.full
spellingShingle Marika Bana
Karin Ribi
Susanne Kropf-Staub
Sabin Zürcher-Florin
Ernst Näf
Tanja Manser
Lukas Bütikofer
Solange Peters
Manuela Eicher
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)
BMJ Open
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort implementation of the symptom navi c programme for cancer patients in the swiss outpatient setting a study protocol for a cluster randomised pilot study symptom navi c pilot study
url https://bmjopen.bmj.com/content/9/7/e027942.full
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