Impact of socioeconomic factors on outcomes in young breast cancer patients after surgery

The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery: an Observational Cohort Study

This study is trying to see how different socioeconomic factors affect the recovery and quality of life for young breast cancer patients in China after they have surgery.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06425874 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to enroll 1000 young breast cancer patients in China, assigning them to three surgical options: breast-conserving surgery, mastectomy alone, and mastectomy with reconstruction. The study will collect data on clinicopathological features, socioeconomic determinants, treatment information, and long-term survival outcomes. Patients will be followed for at least 10 years, with assessments of quality of life, psychological well-being, and decision-making factors at regular intervals. The primary focus is to understand how socioeconomic factors influence patient-reported outcomes post-surgery.

Who should consider this trial

Good fit: Ideal candidates are young women aged 18 to 50 with unilateral breast cancer who are eligible for surgery.

Not a fit: Patients with bilateral breast cancer, inflammatory breast cancer, or those unable to tolerate surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how socioeconomic factors affect the quality of life and satisfaction among young breast cancer patients after different surgical options.

How similar studies have performed: While there have been studies on surgical outcomes in breast cancer, this specific focus on socioeconomic determinants in a young patient population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 50 years old.
* The surgery time and procedure have been confirmed, and the surgical informed consent and research informed consent forms have been signed.
* Informed consent obtained from patient.
* Unilateral Breast Cancer.
* Good health,the patient is able to tolerate general anesthesia and surgery, with an ECOG performance status of ≤2 points.
* No history of breast/axillary radiation therapy.
* Willing and capable of complying with the study protocol visits, treatment plans, and other research procedures.

Exclusion Criteria:

* Bilateral breast cancer.
* Inflammatory breast cancer.
* Stage IV breast cancer.
* Physical examination and imaging suggest tumor infiltration into the skin, pectoralis major muscle, and other adjacent tissues.
* Patients unable to tolerate surgery due to coagulation abnormalities.
* In patients without evidence of breast cancer in the contralateral breast, requesting contralateral prophylactic mastectomy.
* In patients who have undergone surgical treatment for breast cancer (including mastectomy, breast-conserving surgery, and mastectomy with implant reconstruction), requesting secondary breast surgery.
* Patients with a history or current diagnosis of other malignancies, excluding thyroid cancer.
* The conditions considered unsuitable for inclusion by researchers.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Kai Chen, MD

Conditions Breast Cancer; Surgery; Quality of Life