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

November 11, 2024 updated by: amstiggelbout, Leiden University Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
  • Netherlands
      • Leiden, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:
          • Tamara Wit, MSc
          • Phone Number: +31(0)715263967
          • Email: t.wit@lumc.nl
        • Contact:
          • Anne Margreet Stiggelbout, PhD
  • Spain
      • Zaragoza, Spain, 50009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of MetroMapping on perceived Shared Decision Making
Time Frame: The time frame is one week after the decision making consultation
To test the impact of MetroMapping on perceived Shared Decision Making. The iSHARE questionnaire for perceived shared-decision making will be used. The questionnaire assesses Shared Decision Making in oncology. The iSHARE has 15 items with dimension scores (0-5) and a total score (0-30). Higher dimension and total scores indicate higher levels of Shared Decision Making.
The time frame is one week after the decision making consultation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of MetroMapping on the decision-making process
Time Frame: Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.

To evaluate the effect of MetroMapping on the decision-making process various outcomes will be used.

  • The Control Preferences Scale (CPS) for the perceived roles in actual decision. The CPS is a single-item 5 point scale (0-4) ranging from passive to active.
  • Decisions Made, an open-ended question to gain insight into the final treatment choice.
  • Decisional Conflict Scale (DCS) is a 16 item questionnaire on a 5 point scale. Total score range from 0 [feels extremely certain about best choice] to 100 [feels extremely uncertain about best choice].

Decisional Regret Scale is a 5 item questionnaire on a 5 point scale, ranging from 1 (strongly agree) to 5 (strongly disagree). A higher number will indicate more regret.
Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of MetroMapping on the care path
Time Frame: Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.
To evaluate the impact of MetroMapping on the carepath several outcomes will be tested. Satisfaction with Cancer Information Profile (SCIPB) is an 7 item questionnaire on a 5 point scale (5-1). Total score ranges from 7-35. Higher score indicating a higher satisfaction with information. Perceived efficacy in Patient-Physician Interactions is a 5 item questionnaire on a scale of 1 to 5. Range of possible scores is (5-25). 25 meaning the highest patient self-efficacy. Trust in Oncologists is an 18 item questionnaire on a 5-point scale (1 to 5). Scores ranging from 18 to 90. A higher score indicates a higher level of trust in the oncologist. Health Literacy is an 3 item questionnaire. Scores ranging from 1 to 5. A higher score indicates a higher level of health literacy. Healthcare Integration (integRATE) is an 4 item questionnaire (0-3) with higher values indicating more integration Person Centered Coordinated Care Experiences (P3CEQ) is an 11 item questionnaire.
Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Vejle Hospital
Medical Center Haaglanden
Hospital Miguel Servet
Sint Franciscus Gasthuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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