Clinical trial NCT03649984: Implementation of the Symptom Navi© Program
Official title: Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Symptom-management
Outpatients
Nurse-led intervention
Implementation
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized waitlist design
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Patients treated in cancer outpatient settings in Switzerland have high unmet care needs, especially in the domain of self-management of symptoms. The Symptom Navi© Program was developed to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units. The acceptability and feasibility of the Symptom Navi© Program was supported by a qualitative study with 10 cancer patients who received semi-structured patient consultations and subsequently used the Symptom Navi© Flyers at home.

The overall objective of the current study is to pilot test the implementation of the Symptom Navi© Program under real-life conditions. The aims are to evaluate procedures, to test preliminary effectiveness and to assess potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods. The unit of randomization are the participating cancer outpatient centres with each centre representing a cluster. Intervention cluster will provide the Symptom Navi© Program, control clusters will provide usual care for symptom-management.

Eligibility criteria: Inclusion Criteria for patients:

* 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

Exclusion Criteria for patients:

* 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

Primary outcomes:
measure: Change in patient-reported symptom interference with daily function
timeFrame: Change from baseline to 16 weeks
Secondary outcomes:
measure: Reach of intervention in terms of proportion of eligible vs. participating patients
timeFrame: Up to 16 weeks
measure: Change in patient-reported self-efficacy
timeFrame: Change from baseline to 16 weeks
measure: Change in patient-reported symptom severity
timeFrame: Change from baseline to 16 weeks
measure: Change in patient-reported quality of nursing care
timeFrame: Change from baseline to 16 weeks
measure: Incidence of Intervention-Emergent Adverse Events
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: Gynäkologisches Tumorzentrum Universitätsspital Basel
city: Bern
country: Switzerland
facility: Oncocare, Klinik Engeried Bern
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Murten
country: Switzerland
facility: Hôpital fribourgeois - Meyriez-Murten / Tagers
city: Rapperswil
country: Switzerland
facility: Tumor- und Brustzentrum ZeTuP Rapperswil
city: Sargans
country: Switzerland
facility: Rundum Onkologie am Bahnhofpark Sargans
city: Solothurn
country: Switzerland
facility: Solothurner Spitäler AG - Kantonsspital Olten / Bürgerspital Solothurn
city: Thun
country: Switzerland
facility: Spital STS AG - Thun
Study officials:
affiliation: UniLausanne
name: Manuela Eicher, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bana 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.
citation: Bana 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.