Clinical trial NCT06685562: The 4D PICTURE Project: Evaluating Metro Mapping As a Method to Support Shared Decision Making in Oncology
Official title: The 4D PICTURE Project - Design-based Data-driven Decision-support Tools: Producing Improved Cancer Outcomes Through User-Centered Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Patients
Melanoma Cancer
Prostate Cancer
Supportive Care in Cancer
Keywords: MetroMapping
Shared Decision Making
Oncology
Service design
care path redesign
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Sint Franciscus Gasthuis
name: Vejle Hospital
name: Hospital Miguel Servet
name: Medical Center Haaglanden
First posted: 2024-11-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult participants aged 18 years and older. The participants will be recruited from specific hospital in three countries:

Prostate cancer patients: Sint Franciscus Gasthuis in Rotterdam, the Netherlands \& Lillebaelt Hospital in Vejle, Denmark Melanoma patients: Leiden University Medical Center in Leiden, the Netherlands, Haaglanden Medical Center in The Hague, the Netherlands \& Miguel Servet University Hospital in Zaragoza, Spain.

Breast cancer patients: Lillebaelt Hospital in Vejle, Denmark \& Miguel Servet University Hospital in Zaragoza, Spain.

Brief summary: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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.

Primary outcomes:
measure: The impact of MetroMapping on perceived Shared Decision Making
timeFrame: The time frame is one week after the decision making consultation
Secondary outcomes:
measure: The impact of MetroMapping on the decision-making process
timeFrame: Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.
Other outcomes:
measure: The evaluation of MetroMapping on the care path
timeFrame: Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.
Locations:
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
Study officials:
References: