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)

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

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.

Related collections

Most cited references 41

Record: found
Abstract: not found
Article: not found

Self-management education: History, definition, outcomes, and mechanisms

Kate Lorig, Halsted R. Holman (2003)

0 comments Cited 501 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

A tutorial on pilot studies: the what, why and how

Lehana Thabane, Jinhui Ma, Rong Chu … (2010)

Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format.

0 comments Cited 492 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

The RE-AIM framework: a systematic review of use over time.

Bridget Gaglio, Jo Shoup, Russell E. Glasgow (2013)

We provided a synthesis of use, summarized key issues in applying, and highlighted exemplary applications in the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We articulated key RE-AIM criteria by reviewing the published literature from 1999 to 2010 in several databases to describe the application and reporting on various RE-AIM dimensions. After excluding nonempirical articles, case studies, and commentaries, 71 articles were identified. The most frequent publications were on physical activity, obesity, and disease management. Four articles reported solely on 1 dimension compared with 44 articles that reported on all 5 dimensions of the framework. RE-AIM was broadly applied, but several criteria were not reported consistently.

0 comments Cited 327 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 9 July 2019

Volume: 9

Issue: 7

Electronic Location Identifier: e027942

Affiliations

[1 ] departmentHedS-FR School of Health Sciences , University of Applied Science and Arts Western Switzerland , Fribourg, Switzerland

[2 ] departmentIUFRS Institut de formation et de recherche en soins , Université de Lausanne Faculté de biologie et médecine , Lausanne, Switzerland

[3 ] departmentQuality ofLife Office , International Breast Cancer Study Group , Bern, Switzerland

[4 ] departmentFachentwicklung Pflege , Lindenhofgruppe , Bern, Switzerland

[5 ] departmentDepartment of Practice Development in Nursing , Solothurner Spitaler AG , Solothurn, Switzerland

[6 ] departmentFHNW School of Applied Psychology , University of Applied Sciences and Arts Northwestern Switzerland , Olten, Switzerland

[7 ] departmentCTU , Universität Bern , Bern, Switzerland

[8 ] departmentDepartement of Oncology , CHUV , Lausanne, Switzerland

Author notes

[Correspondence to ] Dr Manuela Eicher; manuela.eicher@ 123456chuv.ch

Author information

Marika Bana http://orcid.org/0000-0002-9988-6299

Karin Ribi http://orcid.org/0000-0003-4724-1197

Article

Publisher ID: bmjopen-2018-027942

DOI: 10.1136/bmjopen-2018-027942

PMC ID: 6615799

PubMed ID: 31289075

SO-VID: 9d454632-9867-4a81-ba94-db49f81921d2

License:

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/.

History

Date received : 15 November 2018

Date revision received : 02 May 2019

Date accepted : 09 May 2019

Funding

Funded by: Swiss Cancer League, Bern, Switzerland;

Funded by: Lindenhofgruppe, Bern, Switzerland;

Funded by: CHUV, Departement of Oncology, Lausanne, Switzerland;

Funded by: Heds-FR, School of Health Sciences, Fribourg, Switzerland;

Funded by: Dr. Hans Altschüler Stiftung, St. Gallen, Switzerland;

Funded by: Institute of Higher Education and Research in Health Care, Faculty of Biology and Medicine, University of Lausanne, Switzerland;

Custom metadata

special-feature unlocked

ScienceOpen disciplines: Medicine

Keywords: self-efficacy,re-aim framework,symptom self-management,nurses/nursing,implementation research

Data availability:

ScienceOpen disciplines: Medicine

Keywords: self-efficacy, re-aim framework, symptom self-management, nurses/nursing, implementation research

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)

Read this article at

Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

iDR24 Conference - Poster Abstracts

Most cited references 41

Self-management education: History, definition, outcomes, and mechanisms

A tutorial on pilot studies: the what, why and how

The RE-AIM framework: a systematic review of use over time.

Author and article information

Journal

Affiliations

Author notes

Author information

Article

History

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 429

Cited by 2

Most referenced authors 1,463