Patient Journey in Advanced Gynecologic Cancers

NCT07015593 | Not Yet Recruiting DMC

• 2 other identifiers: NIS103233[2024]S257
• Study Type: observational
• Target: 780
• Locations: 1 country
• Sites: 4

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.

Conditions

Genital Neoplasms, Female; Uterine Cervical Neoplasms; Endometrial Carcinoma

Outcome Measures

Primary Outcomes (3)

• Treatment decision making

  1. Information seeking in treatment decision 2. Treatment decision making factors 3. Clinical trial awareness

  1 day. At the time of the interview.

• Initial treatment experiences

  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

  1 day. At the time of the interview.

• Unmet needs and gaps from diagnosis to post-treatment surveillance

  1. Psychological and emotional needs 2. Social support needs 3. Healthcare needs 4. Gaps during follow-up care

  1 day. At the time of the interview.

Study Arms (1)

experimental group

780 patients for interview

Other: interview

Interventions

interview OTHER

30 for Qualitative interview and 750 for quantitative survey

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (4)

Ying Zhou

Hefei, Anhui, 230001, China

Location

Shuzhong Yao

Guangzhou, Guangdong, 510080, China

Location

Gang Chen

Wuhan, Hubei, 430030, China

Location

Dongling Zou

Chongqing, 430030, China

Location

MeSH Terms

Conditions

Genital Neoplasms, Female; Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gang Chen, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Chen

CONTACT

086-027-83662681; tjchengang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)