Implementation of the Symptom Navi© Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-17

Study Completion Date

2019-04-12

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.

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster-randomized waitlist design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Symptom Navi© Program

Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers

Group Type EXPERIMENTAL

Symptom Navi© Program

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No