Patient Journey in Advanced Gynecologic Cancers

NCT07015593 — Not yet recruiting, 780 participants, Tongji Hospital

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

RegistryNCT07015593
StatusNot yet recruiting
Study typeObservational
Enrollment780 (Estimated)
SponsorTongji Hospital (Other)
ConditionsGenital Neoplasms, Female, Uterine Cervical Neoplasms, Endometrial Carcinoma
Interventionsinterview (Other)
Datesstart 2025-07-01 (estimated), primary completion 2026-07-01 (estimated), completion 2026-11-30 (estimated), first posted 2025-06-11, last updated 2025-06-11
Locations4 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Genital Neoplasms, Female All trials for Uterine Cervical Neoplasms All trials of interview

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
experimental groupOther: interview780 patients for interview
  • interview (Other): 30 for Qualitative interview and 750 for quantitative survey

+Outcome measures

Primary outcomes

  • Treatment decision making [1 day. At the time of the interview.]: 1. Information seeking in treatment decision 2. Treatment decision making factors 3. Clinical trial awareness
  • Initial treatment experiences [1 day. At the time of the interview.]: 1. Influence of treatment on daily life and work 2. Information and education during treatment 3. Coordination of care 4. Overall impression on care received and doctor/nurses' availability
  • Unmet needs and gaps from diagnosis to post-treatment surveillance [1 day. At the time of the interview.]: 1. Psychological and emotional needs 2. Social support needs 3. Healthcare needs 4. Gaps during follow-up care

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (4)

FacilityCityCountryStatus
Ying ZhouHefei, AnhuiChina
Shuzhong YaoGuangzhou, GuangdongChina
Gang ChenWuhan, HubeiChina
Dongling ZouChongqingChina

+Investigators