Patient Report Outcome-Reconstruction and Oncoplastic Cohort

Recruiting

• Conditions: Breast Reconstruction; Oncoplastic Breast-conserving Surgery; Breast Cancer; Patient Reported Outcome Measures
• Interventions: Procedure: breast reconstruction; Procedure: oncoplastic breast-conserving surgery

• Registration Number: NCT04030845
• Lead Sponsor: Fudan University

Brief Summary

Available studies that focused on patient-reported outcomes (PROs) were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (BR) or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to to sign the informed consent and will be followed up 24 months after operations. All data will be collected using an app software.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-01
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-25
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

1. Breast cancer patients;
2. Adult (>18 years old);
3. Female;
4. Must undergo breast reconstruction or oncoplastic breast-conserving surgery;

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Exclusion Criteria

1. Younger (<18 years old);
2. Male;
3. Stage IV breast cancer patients;
4. Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast reconstruction	breast reconstruction	-
oncoplastic breast-conserving surgery	oncoplastic breast-conserving surgery	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in BREAST-Q score	Change from baseline at 1 year and 2 years post-operatively.	The Breast-Q© is a patient reported outcome measure (PROM) for breast surgery that was rigorously developed to accurately measure patient reported satisfaction and quality of life (QOL). (http://www.mskcc.org/mskcc/shared/Breast-Q/index.html). The BREAST-Q was developed and validated with adherence to international guidelines. This PROM is composed of six scales that address: 1) psychosocial well-being, 2) physical well-being, 3) sexual well-being, 4) satisfaction with breasts, 5) satisfaction with outcome, and 6) satisfaction with care. Each module generates a Q-score on a 0-100 scale that can be used for quantitative analysis to enable statistical comparison of the pre- to the post-operative state.
Change from baseline in health-related quality of life measured by EORTC QLQ-C30	Change from baseline at 1 year and 2 years post-operatively.	To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) from baseline at 1 year and 2 years post-operatively. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
Change from baseline in health-related quality of life measured by EORTC QLQ-BR23	Change from baseline at 1 year and 2 years post-operatively.	EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.

Secondary Outcome Measures

Name	Time	Method
Rates of complications	up to 24 months	complications includes overall complication，implant loss, seroma, wound-skin infection, nipple or skin flap necrosis, hematoma, reoperation, wound dehiscence, capsular contracture
Change from baseline in cosmetic scores rated by patients	Change from baseline at 1 year and 2 years post-operatively.	Cosmetic outcomes scored by the patients. Cosmetic scores rates from 0 to 5, which 0 means very dissatisfied, and 5 means very satisfied.
breast aesthetics	up to 24 months	An anterior view picture of the patient will be taken with the patients hands on the hips at baseline (before surgery), postoperative 3, 12 and 24 months in order to assess breast aesthetics. A panel of at least three independent observers blinded to patient identity, treatment allocation, and radiotherapy center scored the photographs. Breast size and surgical deficit were scored from the baseline photographs on a 3-point scale (small, medium, large). After radiotherapy, breast appearance change (none/mild/marked) was scored on a pair of photographs with standard positions in comparison with the baseline photograph.
Overall survival	up to 24 months	Overall survival (OS) was defined as the time from beginning treatment to the time of death from any cause or the date of last contact if death was not recorded before the cutoff date.
Recurrence-free survival	up to 24 months	Recurrence-free survival (RFS) was calculated as time from breast cancer diagnosis until locoregional (LRRFS) or distant recurrence (DRFS) or death due to breast cancer, whichever came first.

Trial Locations

Locations (1)

Shanghai Cancer Center, Fudan University; 🇨🇳 Shanghai, Shanghai, China