RecruitingNCT06425874

The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

1,000 participants

Start Date

Feb 29, 2024

Study Type

OBSERVATIONAL

Conditions

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. Dauplat's 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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.

Interventions

PROCEDUREBreast-conserving surgery

Breast-conserving surgery

PROCEDUREMastectomy

Mastectomy without reconstruction

PROCEDUREMastectomy with reconstruction

Any type of reconstruction(include implant and autologous)


Locations(1)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06425874


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