Ireland
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Recruiting Observational

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

NCT06425874 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-02-29
Last updated
2024-05-22

Condition(s) studied

Breast CancerSurgeryQuality of Life

Investigational drug(s) / intervention(s)

Breast-conserving surgeryMastectomyMastectomy with reconstruction

Breast-conserving surgery: Breast-conserving surgery

Mastectomy: Mastectomy without reconstruction

Mastectomy with reconstruction: Any type of reconstruction(include implant and autologous)

Study 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
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0 — Pre-operation and 10 years
    Utilizing the BREAST-Q questionnaire, this measure assesses women's self-reported satisfaction with their breasts and associated quality of life, encompassing psychosocial, sexual, and physical well-being. Scores range from 0 (worst) to 100 (best), with higher scores indicating a more favorable outcome.Assessment is conducted preoperatively and 10 years postoperatively.
  • Participant's health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) — 10 years
    Assessed through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), this self-administered questionnaire consists of 30 items designed to evaluate the health-related quality of life among cancer patients. For questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome.Assessment is conducted 10 years postoperatively.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Memorial Hospital,Sun Yat-sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06425874 on ClinicalTrials.gov ↗ ← All trials in China