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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425874
• Other study ID #: SYSKY-2024-147-01
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: December 1, 2035

Study information

• Verified date: May 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Kai Chen, MD
• Phone: 15920164730
• Email: chenkai23[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study is a prospective, observational cohort study aiming to enroll 1000 young Chinese breast cancer patients and assign them to three arms: Breast-conserving surgery, mastectomy alone, and mastectomy with breast reconstruction, based on their clinical decisions and preferences. Clinicopathological features (age,Tumor, Node, Metastasis stages, pathological features, etc.), socioeconomic determinants (education level, income, insurance status, marital status, occupational status, personality, etc.), treatment information (neoadjuvant chemotherapy or not, post-operative complications), and survival (local recurrence, metastasis) will be recorded.

All patients will be followed at 6 and 12 months for the first year after diagnosis, then yearly thereafter for an additional 9 years (for a total follow-up of at least 10 years following diagnosis). During the post-operative follow-up, quality of life, psychological well-being, decision regret, surgical information, treatment costs, and surveillance-follow-up will be recorded.

The primary endpoint of this study is the quality of life, assessed using the Breast-Q and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Secondary endpoints include decisional conflict scale, decision regret scales, and the Hospital Anxiety and Depression Scale (HADS).

The primary and secondary endpoints will be compared among the three arms, and the impact of socioeconomic determinants at baseline on these endpoints will also be investigated. Additionally, the investigators aim to explore the potential of a novel subtyping method for young breast cancer patients using selected socioeconomic determinants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2035
• Est. primary completion date: December 1, 2035
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Surgery

Intervention

Procedure:
• Breast-conserving surgery
Breast-conserving surgery
• Mastectomy
Mastectomy without reconstruction
• Mastectomy with reconstruction
Any type of reconstruction(include implant and autologous)

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Surg. 2021 Oct 1;156(10):989-990. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Influence of Socioeconomic, Psychological, and Clinicopathological Factors on Outcomes	Exploring the Influence of Socioeconomic, Psychological, and Clinicopathological Features on Primary and Secondary Outcomes.	Pre-operation and 10 years
Primary	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
Primary	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	Participant's decisional conflict assessed by Decisional Conflict Scale questionnaire	Administered pre-operation, this tool evaluates the patient's conflict regarding the decision for surgery. Each item is rated on a Likert Scale with five responses, ranging from 0 ("Not at All") to 4 ("Extremely"), resulting in a total score ranging from 0 (Less conflicted) to 100 (Highly conflicted).Assessment is conducted preoperatively.	Pre-Operative
Secondary	Participant's decision regret assessed by Decision Regret Scale questionnaire	Conducted during follow-up sessions, this assessment captures the patient's sentiments and remorse regarding the treatment-related decision to undergo surgery. Five items specifically inquire about feelings of regret. Scores range from 0 to 100, with a higher score indicating a greater level of decision-related regret.Assessment is conducted 10 years postoperatively.	10 years
Secondary	Participant's anxiety and depression assessed by Hospital Anxiety and Depression Scale questionnaire	Administered during follow-ups, this scale measures the patient's psychological change. The HADS comprises two 7-item subscales assessing depression and anxiety symptoms separately. Higher scores indicate greater levels of depression and/or anxiety.Assessment is conducted preoperatively and 10 years postoperatively.	Pre-operation and 10 years