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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

18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Rate of prescriptions for a 4th or 5th line of chemotherapy

Outcome Description:

When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.

Outcome Time Frame:

At the time of progression on 3rd or 4th line of chemotherapy.

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard


France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:




Start Date:

November 2008

Completion Date:

June 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic breast cancer
  • Supportive care
  • Third or fourth line of chemotherapy
  • Quality of life
  • Treatment preferences
  • Breast Neoplasms