A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 874
- 试验地点
- 1
- 主要终点
- Duration of combined Appraisal and Help-seeking intervals
研究概览
简要总结
This study evaluates whether the Potlako+ intervention of community education, clinical provider support, and patient navigation can improve access to cancer case for patients presenting with symptoms of cancer. Half of communities will receive the Potlako+ intervention, while the other communities will continue to receive standard programs.
详细描述
The Potlako+ trial is a pair-matched, community-randomized study involving 20 rural and peri-urban communities in Botswana (population ~190,100 with ~100,000 30 years or older). Communities will be randomized 1:1 to the Potlako+ intervention versus standard care. The goal of the intervention is to identify individuals with symptoms/signs suggestive of cancer and expedite diagnosis (and treatment).
The trial includes a community education component focused on cancer awareness and importance of early diagnosis and a patient navigation component that aims to expedite the diagnostic evaluation. Community education will be directed at approximately 50,000 community residents (30 years and older). We anticipate approximately 1500 cancer suspects will be identified by their clinic providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Botswana citizen
- •Age 30 years or older
- •engaged in longitudinal care for chronic health problem
- •resident of study community
排除标准
- •Involuntary incarceration
- •Educational messaging could interfere with clinical management or increase distress in the opinion or clinic or research staff
- •Cancer suspects
- •Inclusion Criteria:
- •Botswana citizen
- •Age 30 years or older
- •resident of study community
- •Recorded as a cancer suspect by clinic staff
- •Exclusion Criteria
- •Involuntary incarceration
- •Unable or unwilling to provide confirmation of informed consent
- •Already engaged in oncology care
结局指标
主要结局
Duration of combined Appraisal and Help-seeking intervals
时间窗: Baseline
Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer
Duration of Pre-Treatment interval
时间窗: From date of cancer diagnosis to date of cancer treatment up to 365 days
Number of days from cancer diagnosis to cancer treatment
Proportion of patients treated with limited stage cancer
时间窗: From date of cancer diagnosis to date of cancer treatment up to 365 days
Among patients with confirmed cancer, proportion treated with stage I/II disease
Duration of Diagnostic interval
时间窗: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer
Incidence of curative-intent treatment
时间窗: From intervention start up to trial end at 1825 days
Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment
次要结局
- Incident low probability cancer syndromes(Baseline)
- Incident invasive procedures in cancer suspects(From intervention start up to trial end at 1825 days)
- Patients treated for cancer(From date of cancer diagnosis to date of cancer treatment up to 365 days)
- Final diagnosis within 8 weeks(From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days)
- Cancer presenting as emergency(From date of cancer diagnosis to date of cancer treatment up to 7 days)
研究者
Scott Lee Dryden-Peterson
Assistant Professor
Brigham and Women's Hospital