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| ID | Type | Description | Link |
|---|---|---|---|
| ET 2007-037 |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Action Group | Experimental |
| |
| Standard care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Action Group | Other | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHVETZOFF Gisèle, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69008 | France | |||
| Institut Curie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16149088 | Background | Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359. | |
| 11248153 | Background | Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101. |
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|
| Standard care | Other | No specific intervention |
|
| 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. |
| Paris |
| 75005 |
| France |
| Institut Curie | Saint-Cloud | 92210 | France |
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| 36574052 | Derived | Chvetzoff G, Bouleuc C, Lardy-Cleaud A, Saltel P, Dieras V, Morelle M, Guastalla JP, Tredan O, Rebattu P, Pop S, Ray-Coquard I, Pierga JY, Mignot L, Laurence V, Bourne-Branchu V, Perol D, Bachelot T. Impact of early palliative care on additional line of chemotherapy in metastatic breast cancer patients: results from the randomized study OSS. Support Care Cancer. 2022 Dec 27;31(1):82. doi: 10.1007/s00520-022-07561-x. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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