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ClinicalTrials.gov ID

NCT07015593

Lead Sponsor

Tongji HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

780Estimated

Last Update Posted

Jun 11, 2025Actual

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Nov 30, 2026Estimated

Official Title

Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China

Brief Summary

This is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.

Detailed Description

This is a mixed-methods survey study including a 2-phased sequential-explanatory design: Phase 1, Qualitative interview will be done first to explore the treatment decision factors, treatment experiences and unmet needs during post treatment surveillance, to provide components and inform the quantitative data collection. Phase 2, quantitative survey to collect data on a larger scale and allow a statistical generation of the qualitative findings.

• Genital Neoplasms, Female
• Uterine Cervical Neoplasms
• Endometrial Carcinoma

• interview

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age 18 or older
• Newly diagnosed stage III or IV CC or EC
• Completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between Dec. 2022 to Dec. 2024 and the therapies were within 6 months after diagnosis.
• Told by their physician that their disease is stable.
• Patients must have informed consent form (ICF) signed for the study.

Exclusion Criteria:

• Previously treated with targeted biologic therapy anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
• Previously participated in or participating in a clinical trial.
• Patients who received another line of therapy after initial therapy.
• Unable or unwilling to provide informed consent.
• Not fluent in local language.
• Indicates or exhibits hearing difficulties, which would make a conversation challenging.

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Tongji HospitalOTHER

yszlfy@163.com086-020-87755766

tjchengang@hust.edu.cn086-027-83662681

cqzl_zdl@163.com086-023-65301682