The Impact of Socioeconomic Determinants on the Patient Reported Outcomes in Young Breast Cancer Patients After Breast Surgery
Recruiting · NCT06425874 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Sun Yat-sen Memorial Hospital,Sun Yat-sen University - Guangzhou, Guangdong, China