Tests a shared decision-making tool for people with breast, prostate or melanoma cancer
Studies whether a care-path mapping method helps adults with cancer make shared treatment decisions.
Key facts
- Who runs it
- Leiden University Medical Center
- Where
- Leiden, NetherlandsSee the siteAlso in 2 other countries, 2 sites
- Trial code
- Registry title
- The 4D PICTURE Project: Evaluating Metro Mapping As a Method to Support Shared Decision Making in Oncology
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 20 Dec 2023
- Planned end
- 20 May 2026
- Type of study
- Observational, 2 groups
- Record updated
- 12 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with prostate cancer, breast cancer or melanoma, or their informal caregivers. It studies how a care path map helps shared decisions in cancer care.
- Age
- Older than 18 years
- Sex
- All sexes can join.
- Disease stage
- Prostate cancer, breast cancer or melanoma. No stage is named.
Main reasons for not taking part
- Cannot give consent
- Cannot speak Dutch, Danish, Spanish or Catalan
- Not an adult (18 years or younger)
- Does not have prostate cancer, breast cancer or melanoma, and is not a caregiver of such a patient
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Adult (>18 years) (either being the patient or the informal caregiver in the care path)
- Prostate cancer, breast cancer or melanoma cancer
- Able to provide consent
- Able to speak Dutch, Danish, Spanish, Catalan
Who cannot take part
- A potential subject who does not meet any of the above criteria will be excluded from participation in this study. There are no further specified exclusion criteria
Where in Netherlands
Also in 2 other countries, 2 sites
- Leiden University Medical CenterLeiden, NetherlandsContact: Tamara Wit, MScTaking people
About the trial
What the trial wants to find out
The goal of this observational study is to evaluate the impact of MetroMapping (a service design methodology) on Shared Decision Making in cancer care paths. The goal is to improve Shared Decision Making and make cancer care paths less overwhelming. The study will include adult participants (older than 18 years) with breast, prostate and melanoma cancers. The main question is How does the implementation of MetroMapping improve Shared Decision Making in cancer care paths.
Read full original descriptionShow less
500 patients, across the Netherlands, Spain, and Denmark, will be enrolled in a pre- and posttest phase. Including 100 breast cancer, 100 prostate cancer, and 50 melanoma patients per phase. To further understand patient experiences, the researchers will audio-record and transcribe the Shared Decision Making consultation of a subset of participants (10 per tumor type per country). A total of 120 audio-recordings across both study phases will be collected. In the post-test phase, a personal care path navigator will be created and the researchers will conduct interviews with 3 patients per care path and interviews with clinicians (12 per country, a total of 36) to assess their experiences with MetroMapping.
The study is a pre-test and post-test multiple methods design, gathering both quantitative and qualitative data across care paths in the Netherlands, Spain and Denmark. Quantitative data will be collected via electronic (Castor EDC \& RedCap) and paper questionnaires. Participants will receive the first set of questionnaires, one week after their decision-making consult. Encompassing the following questionnaires (I-SHARE for perceived Shared Decision Making, Control Preferences Scale for the perceived roles in the actual decision, Decisions Made, Decisional Comfort Scale, SCIP B Information Provision, PEPPI-5 Perceived Efficacy in Patient-Physician Interactions, Trust in Oncologists, Health Literacy) and for the cost-effectiveness analysis for our partner (UMIT TIROL) the EORTC QLU C10-D and EQ-5D5l will be added to assess utilities. In the post-test participants will receive the second set of questionnaires, 6 months after the first set of questionnaires. This set encompasses (Healthcare Integration INTEGrate, Person Centered Coordinated Care Experiences P3CEQ, Decisional Regret Scale, Trust in Oncologists, EORTC QLU-C10D, EQ-5D5L, Productivity Cost Questionnaires.
This study includes a pre-implementation comparison group, and results will be compared with post-implementation outcomes.
Participants will complete the questionnaires and provide demographic and clinical data (consent for sharing medical file is asked) and an audio-recording of their consultation will be made. Participants in the post-phase will participate in interviews about their experiences with the implementation of MetroMapping.
The audio-recordings will be transcribed and analyzed using the OPTION and 4SDM coding instruments. Data will be analyzed using both univariate and multivariate statistical methods. Transcript of audio-recordings will be analyzed using thematic analysis and the coding instruments.
The 2 groups in the trial
- Pre-test patients
Prostate cancer patients, breast cancer patients, and melanoma patients from Spain, Denmark and the Netherlands recruited in the pre-test phase to observe care as usual
- Post-test patients
Prostate cancer patients, breast cancer patients, and melanoma patients from Spain, Denmark and the Netherlands recruited in the pre-test phase to observe care with the implementation of MetroMapping
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The 4D PICTURE Project - Design-based Data-driven Decision-support Tools: Producing Improved Cancer Outcomes Through User-Centered Research
- Plain-language title
- Tests a shared decision-making tool for people with breast, prostate or melanoma cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 November 2024