Implementation of the Symptom Navi© Program
1 other identifier
interventional
134
1 country
9
Brief Summary
The Symptom Navi© Program is a program to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units.The current study aims to pilot test the implementation of the Symptom Navi© Program under real-life conditions by evaluating procedures, testing preliminary effectiveness and assessing potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Oct 2017
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2017
CompletedFirst Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2019
CompletedAugust 24, 2020
August 1, 2020
1.5 years
May 30, 2018
August 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in patient-reported symptom interference with daily function
Symptom interference with daily function in the affective and activity subdimension scores of the MD Anderson Symptom Inventory (MDASI)
Change from baseline to 16 weeks
Secondary Outcomes (5)
Reach of intervention in terms of proportion of eligible vs. participating patients
Up to 16 weeks
Change in patient-reported self-efficacy
Change from baseline to 16 weeks
Change in patient-reported symptom severity
Change from baseline to 16 weeks
Change in patient-reported quality of nursing care
Change from baseline to 16 weeks
Incidence of Intervention-Emergent Adverse Events
Up to 16 weeks
Study Arms (2)
Symptom Navi© Program
EXPERIMENTALNurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers
Standard care
NO INTERVENTIONStandard care including information about treatment, potential side effects and expected symptoms under treatment with or without additional written material following the established procedure at the centre.
Interventions
Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home.
Eligibility Criteria
You may qualify if:
- age ≥ 18 years
- newly diagnosed with cancer within 15 weeks prior to informed consent signature
- planned to receive first cycle of their first-line pharmacological anti-cancer treatment in an outpatient centre (intravenous, oral or subcutaneous)
- signed informed consent
You may not qualify if:
- not sufficiently literate in German language to understand written information or follow an interview
- recurrence of cancer disease
- cared by a palliative care team
- being treated solely with surgical or radiation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manuela Eicherlead
Study Sites (9)
Kantonsspital Aarau
Aarau, Switzerland
Gynäkologisches Tumorzentrum Universitätsspital Basel
Basel, Switzerland
Oncocare, Klinik Engeried Bern
Bern, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
Hôpital fribourgeois - Meyriez-Murten / Tagers
Murten/Morat, Switzerland
Tumor- und Brustzentrum ZeTuP Rapperswil
Rapperswil, Switzerland
Rundum Onkologie am Bahnhofpark Sargans
Sargans, Switzerland
Solothurner Spitäler AG - Kantonsspital Olten / Bürgerspital Solothurn
Solothurn, Switzerland
Spital STS AG - Thun
Thun, Switzerland
Related Publications (3)
Bana M, Ribi K, Peters S, Kropf-Staub S, Naf E, Zurcher-Florin S, Stoffel B, Blaeuer C, Borner M, Malin D, Biber R, Betticher D, Kuhn-Bachler T, Cantoni N, Seeger T, Butikofer L, Eicher M; Symptom Navi Program Group. 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). Cancer Nurs. 2021 Nov-Dec 01;44(6):E687-E702. doi: 10.1097/NCC.0000000000000995.
PMID: 34507338DERIVEDBana M, Ribi K, Kropf-Staub S, Naf E, Schramm MS, Zurcher-Florin S, Peters S, Eicher M. Development and implementation strategies of a nurse-led symptom self-management program in outpatient cancer centres: The Symptom Navi(c) Programme. Eur J Oncol Nurs. 2020 Feb;44:101714. doi: 10.1016/j.ejon.2019.101714. Epub 2019 Dec 20.
PMID: 31954227DERIVEDBana M, Ribi K, Kropf-Staub S, Zurcher-Florin S, Naf E, Manser T, Butikofer L, Rintelen F, Peters S, Eicher M. 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). BMJ Open. 2019 Jul 9;9(7):e027942. doi: 10.1136/bmjopen-2018-027942.
PMID: 31289075DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Manuela Eicher, Prof. Dr.
UniLausanne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 30, 2018
First Posted
August 28, 2018
Study Start
October 17, 2017
Primary Completion
April 12, 2019
Study Completion
April 12, 2019
Last Updated
August 24, 2020
Record last verified: 2020-08