Cancer
Conditions
Keywords
Symptom-management, Outpatients, Nurse-led intervention, Implementation
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.
Interventions
BEHAVIORALSymptom 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.
Sponsors
Manuela Eicher
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
cluster-randomized waitlist design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported symptom interference with daily function | Change from baseline to 16 weeks | Symptom interference with daily function in the affective and activity subdimension scores of the MD Anderson Symptom Inventory (MDASI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach of intervention in terms of proportion of eligible vs. participating patients | Up to 16 weeks | — |
| Change in patient-reported self-efficacy | Change from baseline to 16 weeks | Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G) |
| Change in patient-reported symptom severity | Change from baseline to 16 weeks | Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI) |
| Change in patient-reported quality of nursing care | Change from baseline to 16 weeks | Quality of nursing care assessed by the Patient-Reported Chemotherapy Indicators of Symptoms and Experiences (PR-CISE) |
| Incidence of Intervention-Emergent Adverse Events | Up to 16 weeks | Adverse events as assessed by CTCAE v4.0 |
Countries
Switzerland
Outcome results
None listed