Clinical trial · Interventional
Implementation of the Symptom Navi© Program
Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symptom Navi© Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Symptom Navi© Program
- description
- Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers
- interventionNames
- Behavioral: Symptom Navi© Program
- type
- NO_INTERVENTION
- label
- Standard care
- description
- Standard 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.
Primary outcomes (1)
- measure
- Change in patient-reported symptom interference with daily function
- timeFrame
- Change from baseline to 16 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDBana 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 34507338
- DERIVEDBana 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 31954227
- DERIVEDBana 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 31289075