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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905281
• Other study ID #: OSS
• Secondary ID: ET 2007-037
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: February 6, 2015
• Start date: November 2008
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• Standard care
No specific intervention

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	Institut Curie	Paris
France	Institut Curie	Saint-cloud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No