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: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sandrine DABAKUYO, PHD; Phone Number: 33 0345348067; Email: sdabakuyo@cgfl.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • Centre Georges Francois Leclerc
    • Contact: Sandrine DABAKUYO, PHD; Phone Number: 33 0345348067; Email: sdabakuyo@cgfl.fr
    • Principal Investigator: Clémentine JANKOWSKI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing breast reconstruction after mastectomy for breast cancer

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	12 months after breast reconstruction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	12 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire		24 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire		36 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire		48 months after breast reconstruction
Health related quality of life scores assessed by Breast Q questionnaire		60 months after breast reconstruction

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Investigators: Principal Investigator: Clementine JANKOWSKI, MD, Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2019
• Primary Completion (Anticipated): May 4, 2024
• Study Completion (Anticipated): May 4, 2025

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Breast Reconstruction
• Other Study ID Numbers: 2018-A011828-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No