Breast Cancer PatientsNCT06685562
The 4D PICTURE Project: Evaluating Metro Mapping As a Method to Support Shared Decision Making in Oncology
An observational study of Breast Cancer Patients and Melanoma Cancer, run by Leiden University Medical Center at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Patients, Melanoma Cancer, Prostate Cancer
- How many people
- 500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Dec 2023to 20 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Tamara Wit, MSc contact
3 sites in 3 countries
Denmark1 site, 1 recruiting
- Recruiting
Sygehus Lillebaelt
Vejle, 7100
Kasper Frank Rudebeck, 020491892, kasper.frank.rudebeck@rsyd.dk
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Tamara Wit, MSc, +31(0)715263967, t.wit@lumc.nl
Anne Margreet Stiggelbout, PhD
Spain1 site, 1 recruiting
- Recruiting
Miguel Servet University Hospital
Zaragoza, 50009
Alba Medina Castillo, +34976765500, albamedina.miguelservet@gmail.com
About this study
Official title: 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.
Read more
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.
- Keywords
- MetroMapping, Shared Decision Making, Oncology, Service design, care path redesign
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time frame is one week after the decision making consultation
Secondary outcomes (1)
The impact of MetroMapping on the decision-making process
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.
Measured: Patients will receive the questionnaires one week after their consultation and 6 months after the consultation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Dec 2023
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sint Franciscus Gasthuis, Vejle Hospital, Hospital Miguel Servet, Medical Center Haaglanden
- Responsible party
- Principal investigator, amstiggelbout, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685562
- Sponsor's protocol ID
- 8423
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 4D PICTURE Project - Design-based Data-driven Decision-support Tools: Producing Improved Cancer Outcomes Through User-Centered Research
- ClinicalTrials.gov ID
- NCT06685562
- Acronym / sponsor ID
- 8423
- Keywords
- MetroMapping, Shared Decision Making, Oncology, Service design, care path redesign
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Sint Franciscus Gasthuis, Vejle Hospital, Hospital Miguel Servet, Medical Center Haaglanden
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara Wit, MSc contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Patients and Melanoma Cancer, run by Leiden University Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne M. Prof. Dr. Anne M. Stiggelbout, PhD (+31(0)715264574, a.m.stiggelbout@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of MetroMapping on perceived Shared Decision Making (time frame: The time frame is one week after the decision making consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.