Breast NeoplasmsQualibreast-MQNCT04918082
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
An observational study of Breast Neoplasms and Quality of Life, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Quality of Life, Survivorship
- What is being tested?
- Quality of life questionnaires
- How many people
- 133 participants
- Where
- 1 siteMartinique
- Study dates
- 28 Oct 2020to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer followed at the Martinique University Hospital
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Neoplasms, Quality of Life, Survivorship
- Being tested
- Quality of life questionnaires
- Keywords
- Breast cancer, Quality of life, Survivorship, Survival, French West Indies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnairesOther
Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of global disorders in patients with breast cancer
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
Measured: 12 months after diagnosis
Assessment of disorders specific to breast cancer patients Assessment of disorders specific to breast cancer patients
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
Measured: 12 months after diagnosis
Assessment of global disorders in patients with breast cancer
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-C30
Measured: 36 months after diagnosis
Assessment of disorders specific to breast cancer patients
Quality of life of patients with invasive breast cancer in Martinique assessed by QLQ-BR23
Measured: 36 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start28 Oct 2020
- Primary completion20 Jan 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisse JOACHIM-CONTARET, Principal investigator, CHU Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918082
- Sponsor's protocol ID
- 20_RIPH3_06
- Other IDs
- 2020-A01290-39
- Acronym
- Qualibreast-MQ
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
- ClinicalTrials.gov ID
- NCT04918082
- Acronym / sponsor ID
- Qualibreast-MQ / 20_RIPH3_06
- Conditions
- Breast Neoplasms, Quality of Life, Survivorship
- Keywords
- Breast cancer, Quality of life, Survivorship, Survival, French West Indies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer followed at the Martinique University Hospital
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnairesPatients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules. | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarisse JOACHIM-CONTARET principal investigator
CHU Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Quality of Life, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of global disorders in patients with breast cancer (time frame: 12 months after diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.