Clinical Trials Directory

Trials / Completed

CompletedNCT03649984

Implementation of the Symptom Navi© Program

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
134 (actual)
Sponsor
Manuela Eicher · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2017-10-17
Primary completion
2019-04-12
Completion
2019-04-12
First posted
2018-08-28
Last updated
2020-08-24

Locations

9 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03649984. Inclusion in this directory is not an endorsement.