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NCT Number: NCT03649984

Implementation of the Symptom Navi© Program

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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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Aarau, Aarau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom Navi© Program

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: Up to 16 weeks

  2. 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)

  3. Change in patient-reported symptom severity

    Time frame: Change from baseline to 16 weeks

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

  4. 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)

  5. Incidence of Intervention-Emergent Adverse Events

    Time frame: Up to 16 weeks

    Adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Manuela Eicher

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2018
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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