Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 610
- 试验地点
- 3
- 主要终点
- Adoption
研究概览
简要总结
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
详细描述
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Patients will be eligible if they:
- •are biological females
- •are aged 18 or older
- •have pathology-confirmed invasive cervical cancer diagnosis
- •have pathology results evaluated at National Health Laboratory in Botswana
- •are citizens of Botswana
- •have no prior history of invasive cervical cancer
排除标准
- •Patients will be excluded if they:
- •are biological males or otherwise born without a cervix
- •are below the age of 18 due to the rarity of cervical cancer in this population
- •do not meet study inclusion criteria
研究组 & 干预措施
Stage 1 Clinic Outreach + Stage 2 High Touch
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).
干预措施: Clinic Outreach (Behavioral)
Stage 1 Clinic Outreach + Stage 2 Low Touch
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
干预措施: Clinic Outreach (Behavioral)
Stage 1 Clinic Outreach + Stage 2 Low Touch
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
干预措施: Low-Touch Strategy (Behavioral)
Stage 1 Clinic Outreach + Stage 2 High Touch
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).
干预措施: High-Touch Strategy (Behavioral)
Stage 1 Enhanced Outreach + Stage 2 Low-Touch
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
干预措施: Enhanced Outreach (Behavioral)
Stage 1 Enhanced Outreach + Stage 2 Low-Touch
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
干预措施: Low-Touch Strategy (Behavioral)
Stage 1 Enhanced Outreach + Stage 2 High-Touch
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.
干预措施: Enhanced Outreach (Behavioral)
Stage 1 Enhanced Outreach + Stage 2 High-Touch
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.
干预措施: High-Touch Strategy (Behavioral)
结局指标
主要结局
Adoption
时间窗: Within 90 days of randomization
Defined as the initiation of cervical cancer treatment within 90 days of randomization.
次要结局
- Reach: First Stage(12 months after randomization)
- Fidelity(12 months after randomization)
- Reach: First Appointment(12 months after randomization)
- Reach: Second Stage(12 months after randomization)
- Reach: Results(12 months after randomization)
研究者
Katharine Rendle
Principal Investigator
Abramson Cancer Center at Penn Medicine