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

Recruiting

• Conditions: Breast Cancer Patients; Melanoma Cancer; Prostate Cancer; Supportive Care in Cancer

• Registration Number: NCT06685562
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Study First Submitted: 2024-10-31
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-05-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of MetroMapping on perceived Shared Decision Making	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.

Secondary Outcome Measures

Name	Time	Method
The impact of MetroMapping on the decision-making process	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.

Trial Locations

Locations (3)

Sygehus Lillebaelt; 🇩🇰 Vejle, Denmark

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Miguel Servet University Hospital; 🇪🇸 Zaragoza, Spain