Patient Reported Outcome MeasuresPRO-ROCNCT04030845
Patient Report Outcome-Reconstruction and Oncoplastic Cohort
An observational study of Patient Reported Outcome Measures and Breast Reconstruction, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Patient Reported Outcome Measures, Breast Reconstruction, Oncoplastic Breast-conserving Surgery
- What is being tested?
- breast reconstruction and oncoplastic breast-conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Dec 2024
- How long will I take part?
- 24 Months
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients are confirmed by histopathologic evaluation without distant metastasis (M0). The patients must fulfill indications of breast cancer surgery according to NCCN clinical guidelines, and do not have any absolute contraindications.
Who may be able to join
- Breast cancer patients;
- Adult (>18 years old);
- Female;
- Must undergo breast reconstruction or oncoplastic breast-conserving surgery;
Who cannot join
- Younger (<18 years old);
- Male;
- Stage IV breast cancer patients;
- Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai Municipality, 200000
Jiong Wu, MD, +862164175590 ext. 88607, wujiong1122@vip.sina.com
About this study
Official title: Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome -Reconstruction and Oncoplastic Cohort
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.
- Conditions
- Patient Reported Outcome Measures, Breast Reconstruction, Oncoplastic Breast-conserving Surgery, Breast Cancer
- Being tested
- breast reconstruction, oncoplastic breast-conserving surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast reconstructionProcedure or surgery
The breast reconstruction mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled tansverse rectus abdominis myocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric artery perforator flaps, etc.), implant based breast reconstruction, autologous flaps combined with implant reconstruction, fat graft, etc.
oncoplastic breast-conserving surgeryProcedure or surgery
The oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques.
| Study group | Role | What they receive |
|---|---|---|
| breast reconstruction | Not described Receives: Procedure: breast reconstruction | |
| oncoplastic breast-conserving surgery | Not described Receives: Procedure: oncoplastic breast-conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BREAST-Q score
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.
Measured: Change from baseline at 1 year and 2 years post-operatively.
Change from baseline in health-related quality of life measured by EORTC QLQ-C30
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.
Measured: Change from baseline at 1 year and 2 years post-operatively.
Change from baseline in health-related quality of life measured by EORTC QLQ-BR23
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.
Measured: Change from baseline at 1 year and 2 years post-operatively.
Secondary outcomes (5)
Rates of complications
complications includes overall complication，implant loss, seroma, wound-skin infection, nipple or skin flap necrosis, hematoma, reoperation, wound dehiscence, capsular contracture
Measured: up to 24 months
Change from baseline in cosmetic scores rated by patients
Cosmetic outcomes scored by the patients. Cosmetic scores rates from 0 to 5, which 0 means very dissatisfied, and 5 means very satisfied.
Measured: Change from baseline at 1 year and 2 years post-operatively.
breast aesthetics
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.
Measured: up to 24 months
Overall survival
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.
Measured: up to 24 months
Recurrence-free survival
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient Reported Outcome MeasuresStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Air Force Medical University, Hunan Province Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Xiamen University, First Affiliated Hospital of Xinjiang Medical University, Hubei Cancer Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Hangzhou
- Responsible party
- Principal investigator, Jiong Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030845
- Sponsor's protocol ID
- SCHBCC-N023
- Acronym
- PRO-ROC
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19.
PubMed 37216212Li L, Yang B, Li H, Yin J, Jin F, Han S, Liao N, Shi J, Ling R, Li Z, Ouyang L, Wang X, Fu P, Ouyang Z, Ma B, Wu X, Wang H, Liu J, Shao Z, Wu J. Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol. BMJ Open. 2019 Dec 15;9(12):e032945. doi: 10.1136/bmjopen-2019-032945.
PubMed 31843846
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Multicenter Prospective Registry of Breast Cancer Patient Reported Outcome -Reconstruction and Oncoplastic Cohort
- ClinicalTrials.gov ID
- NCT04030845
- Acronym / sponsor ID
- PRO-ROC / SCHBCC-N023
- Conditions
- Patient Reported Outcome Measures, Breast Reconstruction, Oncoplastic Breast-conserving Surgery, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University, Guangdong Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of Air Force Medical University, Hunan Province Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital of Zhejiang University, The First Affiliated Hospital of Xiamen University, First Affiliated Hospital of Xinjiang Medical University, Hubei Cancer Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Hangzhou
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Jul 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast reconstruction | – | Procedure: breast reconstruction |
| oncoplastic breast-conserving surgery | – | Procedure: oncoplastic breast-conserving surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients are confirmed by histopathologic evaluation without distant metastasis (M0). The patients must fulfill indications of breast cancer surgery according to NCCN clinical guidelines, and do not have any absolute contraindications.
Key inclusion criteria (4 listed)
- Breast cancer patients;
- Adult (>18 years old);
- Female;
- Must undergo breast reconstruction or oncoplastic breast-conserving surgery;
Key exclusion criteria (4 listed)
- Younger (<18 years old);
- Male;
- Stage IV breast cancer patients;
- Refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast reconstructionThe breast reconstruction mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled tansverse rectus abdominis myocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric artery perforator flaps, etc.), implant based breast reconstruction, autologous flaps combined with implant reconstruction, fat graft, etc. | Procedure or surgery | breast reconstruction |
| oncoplastic breast-conserving surgeryThe oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques. | Procedure or surgery | oncoplastic breast-conserving surgery |
Primary outcome
Change from baseline in BREAST-Q score
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Rates of complications
Time frame: up to 24 months
Change from baseline in cosmetic scores rated by patients
Time frame: Change from baseline at 1 year and 2 years post-operatively.
breast aesthetics
Time frame: up to 24 months
Overall survival
Time frame: up to 24 months
Recurrence-free survival
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 37216212Chi W, Zhang Q, Li L, Chen M, Xiu B, Yang B, Wu J. Immediate Breast Reconstruction After Neoadjuvant Chemotherapy: Factors Associated With Surgical Selection and Complications. Ann Plast Surg. 2023 Jul 1;91(1):48-54. doi: 10.1097/SAP.0000000000003574. Epub 2023 May 19.
- Derived from this study: PubMed 31843846Li L, Yang B, Li H, Yin J, Jin F, Han S, Liao N, Shi J, Ling R, Li Z, Ouyang L, Wang X, Fu P, Ouyang Z, Ma B, Wu X, Wang H, Liu J, Shao Z, Wu J. Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol. BMJ Open. 2019 Dec 15;9(12):e032945. doi: 10.1136/bmjopen-2019-032945.
- Individual participant dataSharing planned: Yes
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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.
Shanghai Cancer Center, Fudan University
Shanghai, China
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 Patient Reported Outcome Measures and Breast Reconstruction, run by Fudan University at 1 site in China.
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 4 inclusion and 4 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 25 Jul 2019. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BREAST-Q score (time frame: Change from baseline at 1 year and 2 years post-operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04030845, which also lists 2 linked publications.
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 25 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.