Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425874
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-29
Brief Title:
The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery an Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast-conserving surgery is the standard treatment for young breast cancer patients while mastectomy with breast reconstruction is an alternative for those who are not eligible for Breast-conserving surgery Several studies have compared the quality of life and patient satisfaction among individuals receiving different types of surgery Breast-conserving surgery mastectomy alone or mastectomy with reconstruction For example Meghan R demonstrated that patients undergoing Breast-conserving surgery experience a higher quality of life compared to those undergoing mastectomy with breast reconstruction whereas J Dauplats study showed that patients who undergo mastectomy with breast reconstruction report a higher quality of life than those who undergo mastectomy alone
However the investigators hypothesize that the advantages of a specific type of surgery over another such as Breast-conserving surgery versus breast reconstruction may vary among patients with different socioeconomic factors For instance the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle
Additionally the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up Furthermore it is worth noting that most current studies have been conducted in Caucasian populations In contrast to Caucasians Asians typically have smaller breast volumes potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes Therefore a study focusing on Asian young breast cancer populations is necessary
However the investigators hypothesize that the advantages of a specific type of surgery over another such as Breast-conserving surgery versus breast reconstruction may vary among patients with different socioeconomic factors For instance the benefits of breast reconstruction over Breast-conserving surgery might be more pronounced in young patients who require a more socially active lifestyle
Additionally the benefits of one type of surgery over another may also vary at different time points during post-operative follow-up Furthermore it is worth noting that most current studies have been conducted in Caucasian populations In contrast to Caucasians Asians typically have smaller breast volumes potentially leading to more significant defects after Breast-conserving surgery and possibly poorer aesthetic outcomes Therefore a study focusing on Asian young breast cancer populations is necessary
Detailed Description:
This study is a prospective observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms Breast-conserving surgery mastectomy alone and mastectomy with breast reconstruction based on their clinical decisions and preferences Clinicopathological features ageTumor Node Metastasis stages pathological features etc socioeconomic determinants education level income insurance status marital status occupational status personality etc treatment information neoadjuvant chemotherapy or not post-operative complications and survival local recurrence metastasis will be recorded
All patients will be followed at 6 and 12 months for the first year after diagnosis then yearly thereafter for an additional 9 years for a total follow-up of at least 10 years following diagnosis During the post-operative follow-up quality of life psychological well-being decision regret surgical information treatment costs and surveillance-follow-up will be recorded
The primary endpoint of this study is the quality of life assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 EORTC QLQ-C30 Secondary endpoints include decisional conflict scale decision regret scales and the Hospital Anxiety and Depression Scale HADS
The primary and secondary endpoints will be compared among the three arms and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated Additionally the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants
All patients will be followed at 6 and 12 months for the first year after diagnosis then yearly thereafter for an additional 9 years for a total follow-up of at least 10 years following diagnosis During the post-operative follow-up quality of life psychological well-being decision regret surgical information treatment costs and surveillance-follow-up will be recorded
The primary endpoint of this study is the quality of life assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 EORTC QLQ-C30 Secondary endpoints include decisional conflict scale decision regret scales and the Hospital Anxiety and Depression Scale HADS
The primary and secondary endpoints will be compared among the three arms and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated Additionally the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None