Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01) (SDM-01)
Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)
Background and Purpose:
Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.
Study Design and Procedures:
This is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:
The SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.
The Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.
What to Expect:
Patients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.
Goal:
The researchers hypothesize that educational training for patients and/or physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Confirmed diagnosis of metastatic breast cancer (MBC).
HER2-negative status (as per ASCO/CAP guidelines).
Patients scheduled to receive or currently receiving their first-line therapy for metastatic disease.
Age ≥ 18 years.
Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
Diagnosis of early-stage breast cancer (non-metastatic).
HER2-positive metastatic breast cancer.
Age < 18 years.
Refusal to sign the study-specific informed consent form.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Physician and Patient Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Experimenteel: Physician Only Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Experimenteel: Patient Only Educated
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
Geen tussenkomst: Usual Care
Patients and oncologists follow standard care processes.
No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient.
Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
Tijdsspanne: Baseline and 6 months
|
A 9-item scale used to measure the level of shared decision-making from the patient's perspective.
Each item is scored on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree).
The total score is transformed to a scale of 0 to 100, where higher scores indicate a higher level of involvement in the decision-making process.
|
Baseline and 6 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 160/2023
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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