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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT00905281
First received: May 5, 2009
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Metastatic Breast Cancer
Other: Action Group
Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    When patients progress under 3rd or 4th line of chemotherapy, rate of prescriptions for a 4th or 5th line will be collected.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Standard care Other: Standard care
No specific intervention

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905281

Contacts
Contact: Gwenaële GARIN, PhD +33 4 26 55 68 24 gwenaelle.garin@lyon.unicancer.fr
Contact: Valérie BOURNE-BRANCHU +33 4 78 78 26 58 valerie.bourne-branchu@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Gisèle CHVETZOFF, MD    +33 4 78 78 26 57    gisele.chvetzoff@lyon.unicancer.fr   
Sub-Investigator: BACHELOT Thomas, MD         
Sub-Investigator: GUASTALLA Jean-Paul, MD         
Sub-Investigator: LANCRY Laurence, MD         
Sub-Investigator: REBATTU Paul, MD         
Sub-Investigator: RAY-COQUARD Isabelle, MD         
Sub-Investigator: TREDAN Olivier, MD         
Sub-Investigator: BIRON Pierre, MD         
Institut Curie Recruiting
Paris, France, 75005
Contact: BOULEUC Carole, MD    +33 1 44 32 46 40    carole.bouleuc@curie.net   
Principal Investigator: BOULEUC Carole, MD         
Sub-Investigator: PIERGA Jean-Yves, MD         
Sub-Investigator: MIGNOT Laurent, MD         
Sub-Investigator: DIERAS Veronique, MD         
Sub-Investigator: COPEL Laure, MD         
Sub-Investigator: COTTU Paul, MD         
Sub-Investigator: LAURENCE Valérie, MD         
Sub-Investigator: PIPERNO Sophie, MD         
Sub-Investigator: POP Simona, MD         
Sub-Investigator: TRESCA Patricia, MD         
Institut Curie Not yet recruiting
Saint-cloud, France, 92210
Contact: BRAIN Etienne, MD    +33 1 47 11 15 15    e.brain@stcloud-huguenin.org   
Principal Investigator: BRAIN Etienne, MD         
Sub-Investigator: GOUPIL A, MD         
Sub-Investigator: GUTIERREZ M, MD         
Sub-Investigator: BENSAOULA O, MD         
Sub-Investigator: BETHUNE-VOLTERS A, MD         
Sub-Investigator: CVITKOVIC F, MD         
Sub-Investigator: MEFTI F, MD         
Sub-Investigator: LEREBOURS F, MD         
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: CHVETZOFF Gisèle, MD Centre Léon Bérard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00905281     History of Changes
Other Study ID Numbers: OSS, ET 2007-037
Study First Received: May 5, 2009
Last Updated: July 31, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Leon Berard:
Metastatic breast cancer
Supportive care
Third or fourth line of chemotherapy
Quality of life
Treatment preferences

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014