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

NCT06425874 | Recruiting

• 1 other identifier: SYSKY-2024-147-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Breast Cancer; Surgery; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Participant's breast satisfaction assessed by BREAST-Q questionnaire version 2.0

  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.

  Pre-operation and 10 years

• 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)

  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.

  10 years

Secondary Outcomes (3)

• Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire

  Pre-Operative

• Participant's decision regret assessed by Decision Regret Scale questionnaire

  10 years

• Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire

  Pre-operation and 10 years

Other Outcomes (1)

• Influence of Socioeconomic, Psychological, and Clinicopathological Factors on Outcomes

  Pre-operation and 10 years

Study Arms (3)

Breast-conserving surgery

Procedure: Breast-conserving surgery

Mastectomy

Procedure: Mastectomy

Mastectomy with reconstruction

Procedure: Mastectomy with reconstruction

Interventions

Breast-conserving surgery PROCEDURE

Breast-conserving surgery

Breast-conserving surgery

Mastectomy PROCEDURE

Mastectomy without reconstruction

Mastectomy

Mastectomy with reconstruction PROCEDURE

Any type of reconstruction(include implant and autologous)

Mastectomy with reconstruction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young breast cancer women.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

Related Publications (7)

• Dominici L, Hu J, Zheng Y, Kim HJ, King TA, Ruddy KJ, Tamimi RM, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Wong JS, Partridge AH, Rosenberg SM. Association of Local Therapy With Quality-of-Life Outcomes in Young Women With Breast Cancer. JAMA Surg. 2021 Oct 1;156(10):e213758. doi: 10.1001/jamasurg.2021.3758. Epub 2021 Oct 13.

  PMID: 34468718 BACKGROUND

• Hanson SE, Lei X, Roubaud MS, DeSnyder SM, Caudle AS, Shaitelman SF, Hoffman KE, Smith GL, Jagsi R, Peterson SK, Smith BD. Long-term Quality of Life in Patients With Breast Cancer After Breast Conservation vs Mastectomy and Reconstruction. JAMA Surg. 2022 Jun 1;157(6):e220631. doi: 10.1001/jamasurg.2022.0631. Epub 2022 Jun 8.

  PMID: 35416926 BACKGROUND

• Diao K, Lei X, He W, Jagsi R, Giordano SH, Smith GL, Caudle A, Shen Y, Peterson SK, Smith BD. Patient-reported Quality of Life After Breast-conserving Surgery With Radiotherapy Versus Mastectomy and Reconstruction. Ann Surg. 2023 Nov 1;278(5):e1096-e1102. doi: 10.1097/SLA.0000000000005920. Epub 2023 May 26.

  PMID: 37232937 BACKGROUND

• Rosenberg SM, Dominici LS, Gelber S, Poorvu PD, Ruddy KJ, Wong JS, Tamimi RM, Schapira L, Come S, Peppercorn JM, Borges VF, Partridge AH. Association of Breast Cancer Surgery With Quality of Life and Psychosocial Well-being in Young Breast Cancer Survivors. JAMA Surg. 2020 Nov 1;155(11):1035-1042. doi: 10.1001/jamasurg.2020.3325.

  PMID: 32936216 BACKGROUND

• Riba LA, Gruner RA, Alapati A, James TA. Association between socioeconomic factors and outcomes in breast cancer. Breast J. 2019 May;25(3):488-492. doi: 10.1111/tbj.13250. Epub 2019 Apr 15.

  PMID: 30983100 BACKGROUND

• Flanagan MR, Zabor EC, Romanoff A, Fuzesi S, Stempel M, Mehrara BJ, Morrow M, Pusic AL, Gemignani ML. A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction. Ann Surg Oncol. 2019 Oct;26(10):3133-3140. doi: 10.1245/s10434-019-07548-9. Epub 2019 Jul 24.

  PMID: 31342397 BACKGROUND

• Dauplat J, Kwiatkowski F, Rouanet P, Delay E, Clough K, Verhaeghe JL, Raoust I, Houvenaeghel G, Lemasurier P, Thivat E, Pomel C; STIC-RMI working group. Quality of life after mastectomy with or without immediate breast reconstruction. Br J Surg. 2017 Aug;104(9):1197-1206. doi: 10.1002/bjs.10537. Epub 2017 Apr 12.

  PMID: 28401542 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental; Mastectomy; Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Kai Chen, MD

CONTACT

15920164730; chenkai23@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 22, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)