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

NCT ID: NCT00905281

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-06-30

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

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Action Group

Group Type: EXPERIMENTAL

Action Group

Intervention Type: 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.

Standard care

Group Type: OTHER

Standard care

Intervention Type: OTHER

No specific intervention

Interventions

Action Group

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.

Intervention Type: OTHER

Standard care

No specific intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CHVETZOFF Gisèle, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Institut Curie

Paris, , France

Institut Curie

Saint-Cloud, , France

Countries

France

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Other Identifiers

ET 2007-037

Identifier Type: -

Identifier Source: secondary_id

OSS

Identifier Type: -

Identifier Source: org_study_id