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

NCT06685562 | Recruiting

• 1 other identifier: 8423
• Study Type: observational
• Target: 500
• Locations: 3 countries
• Sites: 3

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.

Conditions

Breast Cancer Patients; Melanoma Cancer; Prostate Cancer; Supportive Care in Cancer

Keywords

MetroMapping; Shared Decision Making; Oncology; Service design; care path redesign

Outcome Measures

Primary Outcomes (1)

• The impact of MetroMapping on perceived Shared Decision Making

  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 Outcomes (1)

• 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.

Other Outcomes (1)

• The evaluation of MetroMapping on the care path

  Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Sint Franciscus Gasthuis: collaborator
• Vejle Hospital: collaborator
• Hospital Miguel Servet: collaborator
• Medical Center Haaglanden: collaborator

Study Sites (3)

Sygehus Lillebaelt

Vejle, 7100, Denmark

RECRUITING

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

Miguel Servet University Hospital

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

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

CONTACT

+31(0)715264574; a.m.stiggelbout@lumc.nl

Tamara Wit, MSc

CONTACT

t.wit@lumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Anne M. Stiggelbout

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 12, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (1); DK (1)