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Trial record 3 of 109 for:    Recruiting, Not yet recruiting, Available Studies | "Laryngeal Diseases"

Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients. (LaDecA)

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ClinicalTrials.gov Identifier: NCT03292341
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
Maastricht University Medical Center
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:

Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options available. In order to help these patients in the decision making process, MAASTRO CLINIC designed and developed a web-based decision aid tool (Treatmentchoice). The aim of this study is twofold: user-testing Treatmentchoice using a systematically development process and establish the impact of the Treatmentchoice on the decision making process.

The study covers 4 chronological activities: 1. assess decisional needs of patients and clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on knowledge, decisional conflict and the shared decision making process, as well as the extent clinicians involve patients in decision making and 4. development of an implementation and dissemination plan for shared decision making which is based on the evaluation of barriers and facilitators for the use of patients decision aid tools in clinical practice.

A mixed method will be used. It comprises structured interviews combined with think aloud and questionnaires with stakeholders involved in the whole process (patients, medical doctors, nurses, general practitioners, patient organizations, and insurance companies).


Condition or disease Intervention/treatment Phase
Larynx Cancer Other: Interviews Other: Treatmentchoice Decisional Tool Other: Questionnaires Other: Interviews with stakeholders Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating a Decision Aid in Clinical Practice for Patients With T3/T4 Laryngeal Cancer
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients

Patients diagnosed with larynx cancer and ex-larynx cancer patients:

  • Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
  • Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool
  • Questionnaires
Other: Interviews
Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs

Other: Treatmentchoice Decisional Tool
Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool

Other: Questionnaires
Patients and physicians fill out questionnaires on the usual care, Delphi study

Experimental: Clinicians

2.Clinicians Radiotherapy-oncologists, ENT(Ear-Nose-Throat)-specialists, General practitioners, Nurses

  • Interviews with patients to define their decisional needs and to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
  • Navigating through the Treatmentchoice Decisional Tool and think aloud while running the tool
  • Questionnaires
Other: Interviews
Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs

Other: Treatmentchoice Decisional Tool
Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool

Other: Questionnaires
Patients and physicians fill out questionnaires on the usual care, Delphi study

Experimental: Other involved organizations
Patient Organizations and insurance companies Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid
Other: Interviews with stakeholders
Interviews with stakeholders Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.




Primary Outcome Measures :
  1. Patient's decisional needs to make a decision about their treatment [ Time Frame: up to 1 year ]
    Patients' decisional needs (development phase):semi-structured interviews with patients about their medical history, their experience with the treatment, the decision about their treatment, and what information the patients need to make

  2. Comprehensibility of the decision aid too [ Time Frame: up to 1 year ]
    Quantitative research using the Unified Theory of Acceptance and Use of Technology (UTAUT Venkatesh et al. 2013). This questionnaire. (5-Likert) measure how patients and clinicians perceived its utility, effectiveness and efficiency for shared decision-making, as well as their satisfaction with the decision aid.

  3. Usability of the decision aid too [ Time Frame: up to 1 year ]
    Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire (5-Likert) measure to what extent the decision aid is easy to use.

  4. Decisional conflict (patients, evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and intervention group (use of the aid tool)

  5. Control Preference Scale (patients; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    Patient's preference to participate in medical decisions will be assessed using the 5-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and intervention group (use of the aid tool)

  6. Perception shared decision-making (patients; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)

  7. . Perception shared decision-making (doctors; evaluation phase) [ Time Frame: 2 weeks after diagnosis ]
    Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)]]


Secondary Outcome Measures :
  1. Patients' views on the current decision-making process [ Time Frame: upto 1 year ]
    Patients' views on the current decision-making process (development phase)

  2. Patients' satisfaction with decision aid (Treatmentchoice) [ Time Frame: upto 1 year ]
    Patients' satisfaction with decision aid (Treatmentchoice) (development phase)

  3. Patients' intention to use and recommend Treatmentchoice to others [ Time Frame: an average of 2 year ]
    Patients' intention to use and recommend Treatmentchoice to others (development phase)

  4. Insights into the value clarification process of prostate cancer patients [ Time Frame: an average of 2 year ]
    Insights into the value clarification process of prostate cancer patients by questionnaires (development phase)


Other Outcome Measures:
  1. Barriers and facilitators for the implementation of Treatmentchoice in clinical practice [ Time Frame: an average of 2 years ]
    Barriers and facilitators for the implementation of Treatmentchoice in clinical practice (implementation phase) will be assessed by questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Larynx cancer patients

    Inclusion Criteria:

    • Larynx cancer: T3 anyN M0, T4 anyN M0
    • Proficient in Dutch
    • minimal 18 years old

    Exclusion Criteria:

    • Patients that do not have a treatment choice (due to contra-indications or other medical reasons)
    • patients with recurrent disease

    For alpha testing patients that already made there decision are selected. For each treatment option (external beam RT, surgery and chemoradiation) at least 10 patients will be included. For beta testing patients that are facing their decision will be included. Aiming for an effect size of 0.60 for a difference in mean total score on the Decisional Conflict Scale, it would require 45 patients per hospital (pre and post intervention) to determine this effect with alpha 0.05 and power 0.80.

  2. Physicians

    • Radiotherapy-oncologists
    • Oncologists
    • General practitioners
    • Nurses For alpha testing at least 10 physicians are selected. For beta testing at least 45 questionnaires are required.
  3. Patient organizations and insurance companies Besides patients and physicians, patient organizations and insurance companies will be involved to evaluate barriers and facilitators for implementation in clinical practice.

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): NCT03292341


Contacts
Contact: Frank Hoebers, MD, PhD +31 88 44 55 666 frank.hoebers@maastro.nl

Locations
Netherlands
MAASTRO Clinic Recruiting
Maastricht, Netherlands, 6229ET
Contact: Frank Hoebers, MD, PhD    +31 (0) 88 44 55 666    frank.hoebers@maastro.nl   
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
The Netherlands Cancer Institute
Investigators
Principal Investigator: Frank Hoebers, MD,PhD Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT03292341     History of Changes
Other Study ID Numbers: 15-28-03/06
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases