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

NCT00905281 | Completed

• 2 other identifiers: OSSET 2007-037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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).

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; Supportive care; Third or fourth line of chemotherapy; Quality of life; Treatment preferences

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• 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

• 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.

Study Arms (2)

Action Group

EXPERIMENTAL

Other: Action Group

Standard care

OTHER

Other: Standard care

Interventions

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.

Action Group

Standard care OTHER

No specific intervention

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (3)

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75005, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• CHVETZOFF Gisèle, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 20, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

FR (3)