Breast CancerRMQOLNCT04938505
Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery
An observational study of Breast Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient. With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2019to 4 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patient undergoing breast reconstruction after mastectomy for breast cancer
Who may be able to join
- Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months
- French speaking and writing fluency
- Agree to participate after receive all information
Who cannot join
- Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
- Patient with a failed first breast reconstruction
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Georges Francois Leclerc
Dijon
Sandrine DABAKUYO, PHD, 0345348067 ext. 33, sdabakuyo@cgfl.fr
Clémentine JANKOWSKI, MD
About this study
Official title: Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)
Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.
With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.
Read more
Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.
Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients
- Conditions
- Breast Cancer
- Keywords
- Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life scores assessed by Breast Q questionnaire
Measured: 12 months after breast reconstruction
Secondary outcomes (7)
Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)
HADS has 14 items rated from 0 to 3 and covers 2 dimensions. Seven questions related to the anxiety dimension and seven other related to the depressive dimension, yielding 2 scores, A (Anxiety) and D (Depression). The maximum score for each dimension is 21. A score of 11 or higher indicates the probable presence of the disorder.
Measured: 12 months after breast reconstruction
social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)
Social support is measured across 2 dimensions: support availability, through the number of contacts that the patient can count on (0 to 9 people) and quality of support, through patient satisfaction with support received. Each item represents a situation in which the patient may need support. Patient is asked to cite the number of people that she could count on in that particular situation. Concerning the second item, the patient is asked to assess satisfaction with the support provided. The scores are generated according to Sarason's recommendations. A score is calculated for each dimension. Support availability score is calculated as the sum of the number of people available for the 6 items, this score ranges from 0 to 54, with 54 representing the highest availability. The social support satisfaction score is calculated by the sum of the satisfaction of the 6 items. This score ranges from 6 to 36, with 36 representing the highest level of satisfaction
Measured: 12 months after breast reconstruction
level of the precariousness and the disparities of health at breast reconstruction patient by the questionnaire Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health (EPICES)
EPICES is used to assess individual level of the precariousness. It includes 11 items and generate precariousness score from 0 to 100. Patient which a score EPICES >30 is considered as having a high level of precariousness
Measured: 12 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Measured: 24 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Measured: 36 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Measured: 48 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Measured: 60 months after breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start4 May 2019
- Primary completion4 May 2024 (estimated)
- Study completion4 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clementine JANKOWSKI, MD, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938505
- Sponsor's protocol ID
- 2018-A011828-47
- Acronym
- RMQOL
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)
- ClinicalTrials.gov ID
- NCT04938505
- Acronym / sponsor ID
- RMQOL / 2018-A011828-47
- Conditions
- Breast Cancer
- Keywords
- Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 4 May 2019 (actual)
- Primary completion
- 4 May 2024 (estimated)
- Study completion
- 4 May 2025 (estimated)
- First posted
- 24 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.
Nowadays, breast reconstruction is an integral care after mastectomy in breast cancer patient.
With the personalized care, choice a breast reconstructive is an important step involving decisions and mutual accord between patients and their physicians in order to anticipate clinical and psychosocial results.
Two main families of breast reconstruction techniques are often performed including advantages and complications impacting health related quality of life.
Routine assessment of health related quality of life in patients underwent breast reconstruction could allow to identify factors of satisfaction o be taken into account in the choice of breast reconstruction technique in order to improve practices and quality of life of patients
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
- Patient undergoing breast reconstruction after mastectomy for breast cancer
Key inclusion criteria (3 listed)
- Normal Breast Checkup ( Mammography, echography and breast magnetic resonance imaging)in the previous 6 months
- French speaking and writing fluency
- Agree to participate after receive all information
Key exclusion criteria (2 listed)
- Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
- Patient with a failed first breast reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life scores assessed by Breast Q questionnaire
Time frame: 12 months after breast reconstruction
7 secondary outcomes
Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months after breast reconstruction
social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)
Time frame: 12 months after breast reconstruction
level of the precariousness and the disparities of health at breast reconstruction patient by the questionnaire Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health (EPICES)
Time frame: 12 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Time frame: 24 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Time frame: 36 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Time frame: 48 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire
Time frame: 60 months after breast reconstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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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.
Clementine JANKOWSKI, MD principal investigator
Centre Georges François Leclerc
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 Cancer, run by Centre Georges Francois Leclerc at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Jun 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine DABAKUYO, PHD (0345348067 ext. 33, sdabakuyo@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life scores assessed by Breast Q questionnaire (time frame: 12 months after breast reconstruction). 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 24 Jun 2021.