NCT Number: NCT00905281
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).
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Notify Me18 year and older
Female
Interventional
Not applicable
Centre Léon Bérard, Lyon, France
The hypothesis tested is that systematic routine consultation between the supportive care team and clinical oncologists will allow more efficient utilization of supportive care by metastatic breast cancer patients, and will reduce the isolation of physicians involved in the management of these patients. Physicians will then be able to help the patients make realistic decisions for the best possible quality of life and in full accordance with their preferences.
The DISSPO (Department of Interdisciplinary Supportive Care for Cancer Patients) focuses on psycho-oncology, pain evaluation and treatment, palliative care, social service, dietary guidance and physiotherapy. Usually, visits with the DISSPO are arranged when the patients need supportive care but are not included in routine care. In this study, contacts between clinical oncologists and supportive care staff will be formalized and systematized. A specific visit called "supportive care visit" will be organized to investigate the needs of the patient so that a personalized care plan can be proposed. Moreover, a consultation between the referring oncologist and the DISSPO will be organized at least once a month.
Besides the main objective of this study (see brief summary), there are secondary objectives which are to evaluate the impact of systematic "Clinical cancer department/Supportive care department" consultation meetings versus standard care on:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At the time of progression on 3rd or 4th line of chemotherapy.
When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.
Time frame: During the period of inclusion in the study: between the inclusion and the time of progression on 3rd or 4th line of chemotherapy
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at inclusion, at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Time frame: Self-administered questionnaire at 6 months and 12 months post-inclusion, at the end and 3 months after the end of the 3rd or 4th line of chemotherapy.
Centre Leon Berard
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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