Study of Impact of Routine Clinical Cancer Department/Supportive Care Department Consultation on the Prescription of an Additional Line of Chemotherapy

Study Overview
=================
Brief 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).

Detailed Description
-----------------
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: the use of supportive care symptom control anxiety-depression levels quality of life patient representations (adaptation to the disease and locus of control) patient perception of social support patient satisfaction with the care impact of disease on the family satisfaction of the referring oncologist

Official Title
-----------------
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

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Other: Action Group
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman aged >= 18 years Metastatic breast cancer with visceral involvement Patient requiring a 3rd or a 4th line of chemotherapy Patient followed at Léon Bérard Cancer Center Patient affiliated with social security Patient able to read and write French Written, voluntary, informed consent Exclusion Criteria: Ongoing chemotherapy other than third or fourth line Only skin or bone metastasis Follow-up impossible for social, geographical, familial or psychological reasons Patient deprived of freedom Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Action Group<br> | Other: Action Group<br>* 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.<br>|
| Other: Standard care<br> | Other: Standard care<br>* No specific intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prescriptions for a 4th or 5th 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. | At the time of progression on 3rd or 4th line of chemotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the number and type of DISSPO interventions |  | During the period of inclusion in the study: between the inclusion and the time of progression on 3rd or 4th line of chemotherapy | 
| Self-evaluation of symptom control using the Edmonton scale |  | 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 | 
| Self-rating of anxiety-depression using the HADS scale |  | 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. | 
| Self-evaluation of quality of life using the QLQC30 scale. |  | 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. | 
| Self-evaluation of adaptation and of the locus of control using the CLCS scale. |  | 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. | 
| Self-evaluation of social support using the QSSP scale |  | 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. | 
| Self-evaluation of satisfaction with care using the F-PMH/PSQ MD scale |  | 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. | 
| Self-evaluation of the impact of disease on family using the GHQ28 scale |  | 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. | 
| Self-evaluation of satisfaction by the referring physician using the Likert scale |  | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic breast cancer, Supportive care, Third or fourth line of chemotherapy, Quality of life, Treatment preferences