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Not yet recruiting NCT07015593

Patient Journey in Advanced Gynecologic Cancers

Observational Genital Neoplasms, Female Uterine Cervical Neoplasms Endometrial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: interview.
Who it may be relevant to
Registry conditions: Genital Neoplasms, Female, Uterine Cervical Neoplasms, Endometrial Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other interview
    30 for Qualitative interview and 750 for quantitative survey

Primary outcome measures

  • Treatment decision making [Time frame: 1 day. At the time of the interview.]
  • Initial treatment experiences [Time frame: 1 day. At the time of the interview.]
  • Unmet needs and gaps from diagnosis to post-treatment surveillance [Time frame: 1 day. At the time of the interview.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 4 centers
  • Ying Zhou — Hefei
  • Shuzhong Yao — Guangzhou
  • Gang Chen — Wuhan
  • Dongling Zou — Chongqing

Identifiers

NCT: NCT07015593 · NIS103233 · [2024]S257

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗