Clinical trial NCT04938505: Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery
Official title: Assessment of Health Related Quality of Life in Women Who Underwent Breast Reconstruction After Radical Surgery (RMQOL)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Reconstruction
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient undergoing breast reconstruction after mastectomy for breast cancer

Brief 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life scores assessed by Breast Q questionnaire
timeFrame: 12 months after breast reconstruction
Secondary outcomes:
measure: Number of anxious and depress participants as assessed by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months after breast reconstruction
measure: social support as assessed by Sarason's Social Support Questionnaire 6-item (SSQ6)
timeFrame: 12 months after breast reconstruction
measure: 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)
timeFrame: 12 months after breast reconstruction
measure: Health related quality of life scores assessed by Breast Q questionnaire
timeFrame: 24 months after breast reconstruction
measure: Health related quality of life scores assessed by Breast Q questionnaire
timeFrame: 36 months after breast reconstruction
measure: Health related quality of life scores assessed by Breast Q questionnaire
timeFrame: 48 months after breast reconstruction
measure: Health related quality of life scores assessed by Breast Q questionnaire
timeFrame: 60 months after breast reconstruction
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
Study officials:
affiliation: Centre Georges François Leclerc
name: Clementine JANKOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
References: