Clinical trial · Interventional
Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients.
Evaluating a Decision Aid in Clinical Practice for Patients With T3/T4 Laryngeal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options available, including total laryngectomy and/or (chemo-) radition. 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 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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interviews | Other | — | UNRESOLVED |
| Interviews with stakeholders | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
| Treatmentchoice Decisional Tool | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Patients
- description
- 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
- interventionNames
- Other: Interviews
- Other: Treatmentchoice Decisional Tool
- Other: Questionnaires
- type
- EXPERIMENTAL
- label
- Clinicians
- description
- 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
- interventionNames
- Other: Interviews
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDHeirman AN, Petersen JF, Al-Mamgani A, Eerenstein SEJ, de Kleijn BJ, Hoebers F, Tijink BM, van der Molen L, Halmos GB, Dirven R, Stuiver MM, van den Brekel MWM. The impact of a patient decision aid for patients with advanced laryngeal carcinoma - a multicenter study. BMC Med Inform Decis Mak. 2025 Jul 1;25(1):217. doi: 10.1186/s12911-025-03080-x. PMID 40597116
- DERIVEDPetersen JF, Berlanga A, Stuiver MM, Hamming-Vrieze O, Hoebers F, Lambin P, van den Brekel MWM. Improving decision making in larynx cancer by developing a decision aid: A mixed methods approach. Laryngoscope. 2019 Dec;129(12):2733-2739. doi: 10.1002/lary.27800. Epub 2019 Jan 21. PMID 30663068