Implementation of the Symptom Navi© Program

Cancer Clinical Trial

Official title:

Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649984
• Other study ID #: Symptom Navi© Pilot Study
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: April 12, 2019

Study information

• Verified date: August 2020
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Symptom Navi© Program
Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home.

Locations

Country	Name	City	State
Switzerland	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
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

Sponsors (1)

Lead Sponsor	Collaborator
Manuela Eicher

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reach of intervention in terms of proportion of eligible vs. participating patients		Up to 16 weeks
Secondary	Change in patient-reported self-efficacy	Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G)	Change from baseline to 16 weeks
Secondary	Change in patient-reported symptom severity	Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI)	Change from baseline to 16 weeks
Secondary	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
Secondary	Incidence of Intervention-Emergent Adverse Events	Adverse events as assessed by CTCAE v4.0	Up to 16 weeks