Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients

NCT03278197 | Completed

• 1 other identifier: 14-40-19/11-intern-6745
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Patients diagnosed with localized prostate cancer may be eligible for different treatment options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid tool for these patients. The goal of the tool is to help patients to understand the treatments, and empower the patients to participate in the decision making process. The aim of this study is threefold: (A) user-testing and validation of the tool, by using a systematically development process compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B) establish the impact of the tool on the decision making process; (C) identify barriers and facilitators for the implementation of shared decision making and the tool in clinical practice. The study covers 3 phases:

1. 1.Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test patients' and clinicians' comprehensibility, acceptability and usability on the alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate cancer patients to determine the most important patient preferences and value clarification aspects the decision aid should include.
2. 2.Implementation phase: Develop an implementation and dissemination plan for shared decision-making which is based on the evaluation of barriers and facilitators for the use of patient decision aid tools in clinical practice.
3. 3.Evaluation phase: Establish the impact of on knowledge, decisional conflict and the shared decision-making process, as well as the extent to which clinicians involve patients in decision-making.

Conditions

Prostate 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 an informed decision

  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

  upto 1 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)

1.Patients

EXPERIMENTAL

Patients diagnosed with prostate cancer and ex-prostate 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

2.Clinicians

OTHER

Radiotherapy-oncologists, Urologists, 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

3.Other involved organizations

OTHER

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.

1.Patients; 2.Clinicians

Treatmentchoice Decisional Tool OTHER

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

1.Patients; 2.Clinicians

Questionnaires OTHER

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

1.Patients; 2.Clinicians

Interviews with stakeholders OTHER

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.

3.Other involved organizations

Eligibility Criteria

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

You may qualify if:

• Stage I-II primary prostate cancer
• Proficient in Dutch
• \> 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 their decision are selected. For each treatment (external beam radiotherapy (RT), interstitial RT, surgery and active surveillance) 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 group (pre and post intervention) to determine this effect with alpha 0.05 and power 0.80.
• For the Delphi study prostate cancer patients who already underwent treatment will be included.
• Clinicians:
• Radiotherapy-oncologists
• Urologists
• 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 will be interviewed to evaluate barriers and facilitators for implementation in clinical practice. The study will focus on their respective roles in the promotion of shared decision making: patient organizations in raising awareness among patients and insurance companies in providing incentives for the use of decision aids in clinical practice.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• Zuyderland Medical Centre: collaborator
• VieCuri Medical Centre: collaborator
• Laurentius Ziekenhuis Roermond: collaborator
• St.Jans Gasthuis Weert: collaborator

Study Sites (1)

Maastro Clinic

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital 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

• Philippe Lambin, 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: February 22, 2017
• First Posted: September 11, 2017
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)