Clinical trial NCT07015593: Patient Journey in Advanced Gynecologic Cancers
Official title: Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Genital Neoplasms, Female
Uterine Cervical Neoplasms
Endometrial Carcinoma
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 780
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is estimated that \~780 patients will be included in this study. For qualitative insights, previous studies have shown that a minimum of 12 respondents (Guest et al. 2006) is required to reach data saturation. A sample size of \~30 will be sufficient to gather qualitative insights and attain saturation. For quantitative survey, considering most of the variables in quantitative survey are categorical variables, we tend to use 50% in the sample size formula since it will provide us with the maximum sample size required for any question, we calculated the sample size to be \~750 with a confidence interval of 95% and margin of error 5%. The number of specific experts interviewed may be fine-tuned depending on actual implementation.

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.

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.

Primary outcomes:
measure: Treatment decision making
timeFrame: 1 day. At the time of the interview.
measure: Initial treatment experiences
timeFrame: 1 day. At the time of the interview.
measure: Unmet needs and gaps from diagnosis to post-treatment surveillance
timeFrame: 1 day. At the time of the interview.
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Ying Zhou
state: Anhui
city: Guangzhou
country: China
facility: Shuzhong Yao
state: Guangdong
city: Wuhan
country: China
facility: Gang Chen
state: Hubei
city: Chongqing
country: China
facility: Dongling Zou
Study officials:
affiliation: Tongji Hospital
name: Gang Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: