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

NCT03292341 | Completed

• 1 other identifier: 15-28-03/06
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Larynx Cancer

Outcome Measures

Primary Outcomes (7)

• Patient's decisional needs to make a decision about their treatment

  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

  up to 1 year

• Comprehensibility of the decision aid too

  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.

  up to 1 year

• Usability of the decision aid too

  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.

  up to 1 year

• Decisional conflict (patients, evaluation phase)

  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)

  2 weeks after diagnosis

• Control Preference Scale (patients; evaluation phase)

  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)

  2 weeks after diagnosis

• Perception shared decision-making (patients; evaluation phase)

  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)

  2 weeks after diagnosis

• . Perception shared decision-making (doctors; evaluation phase)

  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)\]\]

  2 weeks after diagnosis

Secondary Outcomes (4)

• Patients' views on the current decision-making process

  upto 1 year

• Patients' satisfaction with decision aid (Treatmentchoice)

  upto 1 year

• Patients' intention to use and recommend Treatmentchoice to others

  an average of 2 year

• Insights into the value clarification process of prostate cancer patients

  an average of 2 year

Other Outcomes (1)

• Barriers and facilitators for the implementation of Treatmentchoice in clinical practice

  an average of 2 years

Study Arms (3)

Patients

EXPERIMENTAL

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; Other: Treatmentchoice Decisional Tool; Other: Questionnaires

Clinicians

EXPERIMENTAL

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; Other: Treatmentchoice Decisional Tool; Other: Questionnaires

Other involved organizations

EXPERIMENTAL

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

Interventions

Interviews OTHER

Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs

Clinicians; Patients

Treatmentchoice Decisional Tool OTHER

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

Clinicians; Patients

Questionnaires OTHER

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

Clinicians; Patients

Interviews with stakeholders OTHER

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.

Other involved organizations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• The Netherlands Cancer Institute: collaborator

Study Sites (1)

MAASTRO Clinic

Maastricht, 6229ET, Netherlands

Location

Related Publications (2)

• Heirman 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 DERIVED

• Petersen 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 DERIVED

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Frank Hoebers, MD,PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: September 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2016
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)