Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 780
- 试验地点
- 4
- 主要终点
- Treatment decision making
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment decision making
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点