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Implementation of the Symptom Navi© Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649984
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Manuela Eicher, University of Lausanne

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Symptom Navi© Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster-randomized waitlist design
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649984


Contacts
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Contact: Marika Bana, M.Sc. +41 26 429 6000 ext 67 Marika.Bana@hefr.ch

Locations
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Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland
Principal Investigator: Nathan Cantoni, Dr. med.         
Gynäkologisches Tumorzentrum Universitätsspital Basel Recruiting
Basel, Switzerland
Principal Investigator: Viola A. Heinzelmann, Prof.         
Oncocare, Klinik Engeried Bern Recruiting
Bern, Switzerland
Principal Investigator: Markus Borner, Prof.         
Kantonsspital Graubünden Recruiting
Chur, Switzerland
Principal Investigator: Michael Schwitter, Dr. med.         
Hôpital fribourgeois - Meyriez-Murten / Tagers Recruiting
Murten, Switzerland
Principal Investigator: Daniel Betticher, Prof.         
Principal Investigator: Vérène Dougoud-Chauvin, Dr. med.         
Tumor- und Brustzentrum ZeTuP Rapperswil Recruiting
Rapperswil, Switzerland
Principal Investigator: Rudolf Morant, Dr. med.         
Rundum Onkologie am Bahnhofpark Sargans Recruiting
Sargans, Switzerland
Principal Investigator: Stefan Greuter, Dr. med.         
Solothurner Spitäler AG - Kantonsspital Olten / Bürgerspital Solothurn Completed
Solothurn, Switzerland
Spital STS AG - Thun Completed
Thun, Switzerland
Sponsors and Collaborators
Manuela Eicher
Investigators
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Study Director: Manuela Eicher, Prof. Dr. UniLausanne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manuela Eicher, Prof. Dr., University of Lausanne
ClinicalTrials.gov Identifier: NCT03649984    
Other Study ID Numbers: Symptom Navi© Pilot Study
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manuela Eicher, University of Lausanne:
Symptom-management
Outpatients
Nurse-led intervention
Implementation