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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom Navi© Program | Experimental | Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers |
|
| Standard care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symptom Navi© Program | Behavioral | Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reach of intervention in terms of proportion of eligible vs. participating patients | Up to 16 weeks | |
| Change in patient-reported self-efficacy | Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G) |
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Inclusion Criteria for patients:
Exclusion Criteria for patients:
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| Name | Affiliation | Role |
|---|---|---|
| Manuela Eicher, Prof. Dr. | UniLausanne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | Switzerland | ||||
| Gynäkologisches Tumorzentrum Universitätsspital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34507338 | Derived | 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. | |
| 31954227 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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cluster-randomized waitlist design
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| Change from baseline to 16 weeks |
| Change in patient-reported symptom severity | Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI) | Change from baseline to 16 weeks |
| Change in patient-reported quality of nursing care | Quality of nursing care assessed by the Patient-Reported Chemotherapy Indicators of Symptoms and Experiences (PR-CISE) | Change from baseline to 16 weeks |
| Incidence of Intervention-Emergent Adverse Events | Adverse events as assessed by CTCAE v4.0 | Up to 16 weeks |
| 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 |
| Derived |
| 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. |
| 31289075 | Derived | 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. |