Implementation of the Symptom Navi© Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Symptom Navi© Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster-randomized waitlist design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptom Navi© Program<br>Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers | Behavioral: Symptom Navi© Program<br>* Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home.<br>|
| No Intervention: Standard care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom-management, Outpatients, Nurse-led intervention, Implementation