A New Tool to Promote Patient's Engagement in Their Healthcare Process
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.
Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be 18 or older;
have received/receive diagnosis of resectable breast cancer in the early stage;
women treated or who will undergo oncological treatment for early breast cancer;
demonstrate the absence of psychopathological features.
Disqualifiers
breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;
neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.
Distant metastases from breast cancer or locally advanced/unresectable disease
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Trial population
Number of healthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews. Moreover, about 10-12 professionals will take part in the steering committee. Number of Patients affected: we will involve patients with early breast cancer for a total of 170 participants, considering all phases of the present project.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Healthcare professionals
Other interventionhealthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews
Patients PDA group
Other interventionParticipants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires
Patients control group
Other interventionParticipants will receive only the online link with the battery of questionnaires
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Stakeholders1 intervention
Group B: Patients PDA group1 intervention
Group C: Patients control group1 intervention
Trial outcomes
Primary outcomes
1
Development of an ad hoc Patient Decision Aid (PDA)
Patients in the Intervention group will receive via mail the final version of the PDA and a battery of questionnaires. Patients in the Control group will receive only the online link with the battery of questionnaires. In both the experimental and the control group, questionnaires will be administered one week after the first medical consultation (T0), one month later the first medical consultation (T1), and three months later the first medical consultations (T2). The difference between T1 and T0 and T2 and T0 will be calculated for each endpoint.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov