Implementation of the Symptom Navi© Program

August 21, 2020 updated by: Manuela Eicher

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital Aarau
      • Basel, Switzerland
        • Gynäkologisches Tumorzentrum Universitätsspital Basel
      • Bern, Switzerland
        • Oncocare, Klinik Engeried Bern
      • Chur, Switzerland
        • Kantonsspital Graubunden
      • Murten, Switzerland
        • Hôpital fribourgeois - Meyriez-Murten / Tagers
      • Rapperswil, Switzerland
        • Tumor- und Brustzentrum ZeTuP Rapperswil
      • Sargans, Switzerland
        • Rundum Onkologie am Bahnhofpark Sargans
      • Solothurn, Switzerland
        • Solothurner Spitäler AG - Kantonsspital Olten / Bürgerspital Solothurn
      • Thun, Switzerland
        • Spital STS AG - Thun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptom Navi© Program
Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers
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.
No Intervention: Standard care
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-reported symptom interference with daily function
Time Frame: 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)
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
Time Frame: Up to 16 weeks
Up to 16 weeks
Change in patient-reported self-efficacy
Time Frame: Change from baseline to 16 weeks
Self-efficacy assessed by the Self-Efficacy for Managing Chronic Disease (SES6G)
Change from baseline to 16 weeks
Change in patient-reported symptom severity
Time Frame: Change from baseline to 16 weeks
Symptom severity assesssed by the MD Anderson Symptom Inventory (MDASI)
Change from baseline to 16 weeks
Change in patient-reported quality of nursing care
Time Frame: Change from baseline to 16 weeks
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
Time Frame: Up to 16 weeks
Adverse events as assessed by CTCAE v4.0
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuela Eicher

Investigators

  • Study Director: Manuela Eicher, Prof. Dr., UniLausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2017

Primary Completion (Actual)

April 12, 2019

Study Completion (Actual)

April 12, 2019

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Symptom Navi© Pilot Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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