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

February 6, 2015 updated by: Centre Leon Berard

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 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre Leon Berard
      • Paris, France, 75005
        • Institut Curie
      • Saint-cloud, France, 92210
        • Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Action Group
Other: 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.
Other: Standard care
Other: Standard care
No specific intervention

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the number and type of DISSPO interventions
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
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
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
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
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.
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.
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.
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.
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.
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
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.
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
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.
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: CHVETZOFF Gisèle, MD, Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSS
  • ET 2007-037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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