Implementation of the Symptom Navi© Program

Manuela Eicher134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

134

Conditions

Cancer

Interventions

Symptom Navi© ProgramBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Kantonsspital Aarau

Aarau, Switzerland

Gynäkologisches Tumorzentrum Universitätsspital Basel

Basel, Switzerland

Oncocare, Klinik Engeried Bern

Bern, Switzerland

Kantonsspital Graubünden

Chur, Switzerland

Outcomes

Primary Outcomes

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)

Time frame: Change from baseline to 16 weeks

Secondary Outcomes

Reach of intervention in terms of proportion of eligible vs. participating patients

Time frame: Up to 16 weeks

Change in patient-reported self-efficacy

Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G)

Time frame: Change from baseline to 16 weeks

Change in patient-reported symptom severity

Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI)

Time frame: 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)

Time frame: Change from baseline to 16 weeks

Incidence of Intervention-Emergent Adverse Events

Adverse events as assessed by CTCAE v4.0

Time frame: Up to 16 weeks

Data from ClinicalTrials.gov

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