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出境医 / 临床实验 / Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique (Qualibreast-MQ)

Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique (Qualibreast-MQ)

Study Description
Brief Summary:
Cancer and its treatments can be factors that alter the quality of life of patients. The induced alteration of the quality of life can influence compliance and impact survival. Considering the after-effects of the treatment, carrying out such a survey will provide for the first time precise information on the main determinants of the quality of life as well as on the care pathway of patients with invasive breast cancer in the Martinique region.

Condition or disease Intervention/treatment
Breast Neoplasms Quality of Life Survivorship Other: Quality of life questionnaires

Detailed Description:
Breast cancer is the second most common cancer in the West Indies and the leading cancer in women. With 215 new cases in Guadeloupe, 204 in Martinique and 56 in French Guiana each year, it accounts for 37%, 33% and 26% of incident cancer cases in women respectively, but also affects men. Its incidence, lower than in France, is increasing over the period 2008-2014. The diagnostic and therapeutic management of cancer can have an impact on the quality of life of patients, taking into account the adverse effects occurring during and after treatment, both in the short and long term. The European Organisation for Research and Treatment of Cancer (EORTC) has developed a series of questionnaires to assess the quality of life of cancer patients, including a general questionnaire (QLQ-C30) and specific modules for breast cancer (EORTC BREAST (EORTC QLQ-BR23)) with the objective of improving professional practices.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2024
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Assessment of global disorders in patients with breast cancer [ Time Frame: 12 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30

  2. Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients [ Time Frame: 12 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23

  3. Assessment of global disorders in patients with breast cancer [ Time Frame: 36 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30

  4. Assessment of disorders specific to breast cancer patients [ Time Frame: 36 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 18, 2021
Actual Study Start Date October 28, 2020
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2021)
  • Assessment of global disorders in patients with breast cancer [ Time Frame: 12 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
  • Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients [ Time Frame: 12 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
  • Assessment of global disorders in patients with breast cancer [ Time Frame: 36 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
  • Assessment of disorders specific to breast cancer patients [ Time Frame: 36 months after diagnosis ]
    Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
Original Primary Outcome Measures
 (submitted: June 2, 2021)
  • Evaluation of the overall quality of life [ Time Frame: 12 months after diagnosis ]
    Evaluation of the overall quality of life of patients with invasive breast cancer in Martinique
  • Evaluation of the overall quality of life [ Time Frame: 36 months after diagnosis ]
    Evaluation of the overall quality of life of patients with invasive breast cancer in Martinique
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
Official Title Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
Brief Summary Cancer and its treatments can be factors that alter the quality of life of patients. The induced alteration of the quality of life can influence compliance and impact survival. Considering the after-effects of the treatment, carrying out such a survey will provide for the first time precise information on the main determinants of the quality of life as well as on the care pathway of patients with invasive breast cancer in the Martinique region.
Detailed Description Breast cancer is the second most common cancer in the West Indies and the leading cancer in women. With 215 new cases in Guadeloupe, 204 in Martinique and 56 in French Guiana each year, it accounts for 37%, 33% and 26% of incident cancer cases in women respectively, but also affects men. Its incidence, lower than in France, is increasing over the period 2008-2014. The diagnostic and therapeutic management of cancer can have an impact on the quality of life of patients, taking into account the adverse effects occurring during and after treatment, both in the short and long term. The European Organisation for Research and Treatment of Cancer (EORTC) has developed a series of questionnaires to assess the quality of life of cancer patients, including a general questionnaire (QLQ-C30) and specific modules for breast cancer (EORTC BREAST (EORTC QLQ-BR23)) with the objective of improving professional practices.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with breast cancer followed at the Martinique University Hospital
Condition
  • Breast Neoplasms
  • Quality of Life
  • Survivorship
Intervention Other: Quality of life questionnaires
Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 2, 2021) 		142
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 28, 2024
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient over 18 years of age residing in Martinique with invasive breast cancer diagnosed from 2020 (single tumor at diagnosis)
  • Patients who have read the information note and have indicated that they do not wish to participate in the study
  • Patient with social security coverage.

Exclusion Criteria:

  • Refusal to participate
  • Patient with insitu breast cancer
  • Patient with a second cancer
  • Patient with cancer within 5 years prior to inclusion
  • Patient who could not answer quality of life questionnaires
  • Patient not fluent in French
  • Person under legal protection (safeguard of justice, guardianship, curators , etc.).
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clarisse JOACHIM-CONTARET +596596559674 clarisse.joachim@chu-martinique.fr
Contact: Mickaelle ROSE +596596592623 mickaelle.rose@chu-martinique.fr
Listed Location Countries Martinique
Removed Location Countries  
 
Administrative Information
NCT Number NCT04918082
Other Study ID Numbers 20_RIPH3_06
2020-A01290-39 ( Other Identifier: DGS, Ministry of Health )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital Center of Martinique
Study Sponsor University Hospital Center of Martinique
Collaborators Not Provided
Investigators
Principal Investigator: Clarisse JOACHIM-CONTARET CHU Martinique
PRS Account University Hospital Center of Martinique
Verification Date June 2021