Actively Recruiting

Age: 18Years +
All Genders
ID06685562

The 4D PICTURE Project - Design-based Data-driven Decision-support Tools: Producing Improved Cancer Outcomes Through User-Centered Research

Led by Leiden University Medical Center · Updated on 2024-11-12

500

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

S

Sint Franciscus Gasthuis

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how MetroMapping, a service design method, affects Shared Decision Making in cancer care paths. This study focuses on adults over 18 with breast, prostate, or melanoma cancer. The goal is to see if MetroMapping makes decision-making easier and less overwhelming for patients. The study includes a comparison before and after implementing MetroMapping across three countries: the Netherlands, Spain, and Denmark. Participants are divided into two groups: those observed before MetroMapping is used and those observed after its implementation. About 500 patients will be enrolled, including 100 breast cancer, 100 prostate cancer, and 50 melanoma patients in each phase. Some patients will have their decision-making consultations audio-recorded and transcribed to better understand their experiences. In the post-implementation phase, a personal care path navigator will be introduced, and interviews with patients and clinicians will explore their views on MetroMapping. Participants will complete questionnaires one week after their decision-making consultation and again six months later. These questionnaires assess Shared Decision Making, patient roles in decisions, comfort with decisions, information provision, trust in oncologists, health literacy, care integration, regret, and quality of life. Researchers will analyze questionnaire responses, audio transcripts, and interviews using various statistical and thematic methods. The study will help determine MetroMapping's impact on patients' decision-making experiences and overall care.

CONDITIONS

Brief Title

The 4D PICTURE Project: Evaluating Metro Mapping As a Method to Support Shared Decision Making in Oncology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults older than 18 years (patients or informal caregivers)
  • Diagnosed with prostate cancer, breast cancer, or melanoma cancer
  • Able to provide consent
  • Able to speak Dutch, Danish, Spanish, or Catalan
Not Eligible

You will not qualify if you...

  • Does not meet any inclusion criteria listed above

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility

Diagnostic Evaluation

Duration - Up to 6 months

Participants undergo observation of care as usual or care with MetroMapping implementation to support shared decision making in oncology.

Questionnaires completed 1 week and 6 months after the decision making consultation

Trial Site Locations

Total: 3 locations

1

Sygehus Lillebaelt

Vejle, Denmark, 7100

Actively Recruiting

2

Leiden University Medical Center

Leiden, Netherlands, 2333ZA

Actively Recruiting

3

Miguel Servet University Hospital

Zaragoza, Spain, 50009

Actively Recruiting

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Research Team

A

Anne M. Prof. Dr. Anne M. Stiggelbout, PhD

T

Tamara Wit, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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