Clinical trial NCT03292341: Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients.
Official title: Evaluating a Decision Aid in Clinical Practice for Patients With T3/T4 Laryngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Larynx Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: The Netherlands Cancer Institute
First posted: 2017-09-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Laryngeal cancer is the second most common head and neck cancer. Each year about 700 people are diagnosed with larynxcarcinoma in the Netherlands (Van Dijk et.al. 2013).

For patients with laryngeal cancer, various treatment options are available, including surgery, radiotherapy, chemotherapy and endoscopic (laser) treatment. Each option has its own benefits and side effects. The optimal treatment for patients having stage 3 or 4 laryngeal cancer is not unambiguously proven. Different treatment options cause different side effects that may impact the patients' health-related quality of life. The treatment of choice depends on preferences and personal values. In these preference-sensitive choices it is important to involve the patient in the decision-making process. In this process both the practitioner and the patient exchange information and collaborate in the decision, the physician knows more technical information about the disease, the treatment options and the side effects, the patient knows how the treatment options correspond with his lifestyle, values and preferences (Frosch DL and Kaplan RM, 1999; O'Connor AM, et.al. 2003; O'Connor AM, et.al., 2004).

Patient Decision Aids (PDAs) are tools that can help patients to get involved in decision making by clarifying treatment options, outcomes, and personal values. In the development process of a decision aid it is mandatory to follow a systematic and iterative approach to: (a) understand patient's decisional needs; (b) create prototypical tools; (c) evaluate these prototypes with patients and clinicians, and (d) use these results to improve the tool.

Considering the International Patient Decision Aid Standards (http://ipdas.ohri.ca/), we designed an initial prototype, called Treatmentchoice (http://www.treatmentchoice.info). These standards recommend assessing patients and doctors views in decisional needs, use this information to develop an alpha version of the PDA and validate it again with patients and doctors to create a beta version.

The aim of this project is user-testing the initial prototype of the Treatmentchoice. This will allow us to follow a systematically development process and to gain knowledge on the validity of our approach. The project covers 4 chronological activities:

ACTIVITY 1: ASSES DECISIONAL NEEDS: Elicit patients and clinicians views on patient's information, expectations, and needs on decision support. Conclusions and recommendations for improvement of Treatmentchoice will be derived and the current prototype will be improved creating an alpha prototype.

ACTIVITY 2: ALPHA-TESTING: Testing patients' and clinicians comprehensibility, acceptability and usability on the alpha-version. A mixed method will be used; structured interviews combined with think aloud (Ahmed, 2009) and questionnaires (Unified Theory of Acceptance and Use of Technology (UTAUT) - Venkatesh et al.2012) with both patients and clinicians (head and neck surgeon,medical oncologists an radiation oncologists). Conclusions and recommendations will be documented. Considering this assessment, the prototype will be improved. Alpha testing will be repeated with this improved prototype using an iterative process, until the tool is comprehensible, acceptable and usable for both patients and physicians. A second assessment will be performed with a beta prototype.

ACTIVITY 3: BETA-TESTING: 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. The study composes the evaluation of the impact of the Treatmentchoice. A variety of questionnaires will be used to assess different outcome measures:

* Age and educational level, home situation with regard to internet connection.
* Knowledge test will be assessed using 20 statements, which can be rated as "true", "not true" or "do not know" (Savelberg, 2015).
* Decisional conflict will be assessed using the Decisional Conflict Scale (DCS). This 16-item scale has five subscales: feeling informed, decisional uncertainty, clear values, support, and quality of decisions. Each of these items is scored on a five-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) (DCS, O'Connor AM, 2010).
* Patient's desire to participate in medical decisions will be assessed using a 5-item Control Preference Scale (Degner 1997).
* The Shared Decision Making (SDM) process will be assessed by the perceptions of patients, using the SDM-Q9 instrument for patients. The instrument provides 9 statements, which can be rated on a six-point scale from 0 (completely disagree) to 5 (completely agree). (SDM-Q9, Rodenburg, 2015 Dutch version).
* The process of SDM will also be assessed by the perceptions of the physician (the oncologist or the radiotherapist if the decision is made together with the radiotherapist), using the SDM-Q9 instrument for professionals. The instrument provides 9 statements, also rated on a six-point scale (SDM-Q9,Rodenburg,2015/Dutch version).

The patients will be asked to fill in the questionnaires at two time points, directly after the decision making process and 3 months after the decision making process. Their physician will be asked to fill in the questionnaire at 1 time point, directly after the decision making process.

ACTIVITY 4: IMPLEMENTATION: Develop an implementation and dissemination plan for shared decision making in prostate cancer. Questionnaires and qualitative interviews will be performed to evaluate barriers and facilitators for implementation in clinical practice, to develop strategies for the implementation of the decision aid and facilitate optimal shared decision making, tailored to the barriers and needs of the end-users. Based on the results, an implementation plan will be written

Eligibility 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.

Primary outcomes:
measure: Patient's decisional needs to make a decision about their treatment
timeFrame: up to 1 year
measure: Comprehensibility of the decision aid too
timeFrame: up to 1 year
measure: Usability of the decision aid too
timeFrame: up to 1 year
measure: Decisional conflict (patients, evaluation phase)
timeFrame: 2 weeks after diagnosis
measure: Control Preference Scale (patients; evaluation phase)
timeFrame: 2 weeks after diagnosis
measure: Perception shared decision-making (patients; evaluation phase)
timeFrame: 2 weeks after diagnosis
measure: . Perception shared decision-making (doctors; evaluation phase)
timeFrame: 2 weeks after diagnosis
Secondary outcomes:
measure: Patients' views on the current decision-making process
timeFrame: upto 1 year
measure: Patients' satisfaction with decision aid (Treatmentchoice)
timeFrame: upto 1 year
measure: Patients' intention to use and recommend Treatmentchoice to others
timeFrame: an average of 2 year
measure: Insights into the value clarification process of prostate cancer patients
timeFrame: an average of 2 year
Other outcomes:
measure: Barriers and facilitators for the implementation of Treatmentchoice in clinical practice
timeFrame: an average of 2 years
Locations:
city: Maastricht
country: Netherlands
facility: MAASTRO Clinic
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Frank Hoebers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.