At a glance
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Randomized Controlled Trial Assessing the Impact of Routine "Oncologist-supportive Care Team" Consultation on the Use of an Additional Line of Chemotherapy in Metastatic Breast Cancer Patients
In Brief
A clinical study evaluating Action Group and Standard care for Metastatic Breast Cancer. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
The purpose of this study is to assess the impact of systematic "clinical cancer department/supportive care department" consultation meetings, versus standard care, on the prescription of an additional line of chemotherapy in patients with metastatic breast cancer and visceral involvement after 3 or 4 lines of chemotherapy. This is a prospective paucicentric open label randomized controlled study with 2 parallel arms. Eligible patients will be randomly assigned to either arm "Study group" or "Standard care". The number of patients required to demonstrate a 30% reduction of the number of prescriptions for an additional line chemotherapy, assuming an alpha risk of 5% and 80% power, is 100 (50 in each arm).
Study Details
Timeline
Interventions
On inclusion, a visit will be organized between the patient and at least 2 members of the DISSPO staff. It will allow an evaluation of supportive care needs and the proposition of a personalized care plan. Then, a consultation between the referring oncologist and the DISSPO will be organized once a month, so that the personalized care plan could be adapted if necessary.
No specific intervention