- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04938505
Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sandrine DABAKUYO, PHD
- Phone Number: 33 0345348067
- Email: sdabakuyo@cgfl.fr
Study Locations
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Dijon, France
- Recruiting
- Centre Georges François Leclerc
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Contact:
- Sandrine DABAKUYO, PHD
- Phone Number: 33 0345348067
- Email: sdabakuyo@cgfl.fr
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Principal Investigator:
- Clémentine JANKOWSKI, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with an inability to complete HRQOL questionnaires (cognitive disorders, language barrier)
- Patient with a failed first breast reconstruction
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health related quality of life scores assessed by Breast Q questionnaire
Time Frame: 12 months after breast reconstruction
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12 months after breast reconstruction
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 months after breast reconstruction
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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.
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12 months after breast reconstruction
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social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)
Time Frame: 12 months after breast reconstruction
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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
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12 months after breast reconstruction
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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
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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
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12 months after breast reconstruction
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Health related quality of life scores assessed by Breast Q questionnaire
Time Frame: 24 months after breast reconstruction
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24 months after breast reconstruction
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Health related quality of life scores assessed by Breast Q questionnaire
Time Frame: 36 months after breast reconstruction
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36 months after breast reconstruction
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Health related quality of life scores assessed by Breast Q questionnaire
Time Frame: 48 months after breast reconstruction
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48 months after breast reconstruction
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Health related quality of life scores assessed by Breast Q questionnaire
Time Frame: 60 months after breast reconstruction
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60 months after breast reconstruction
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clementine JANKOWSKI, MD, Centre Georges François Leclerc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018-A011828-47
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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