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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
874
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
Provider education and limited patient counseling.
Botswana Harvard AIDS Institute
Gaborone, Botswana
Duration of combined Appraisal and Help-seeking intervals
Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer
Time frame: Baseline
Duration of Diagnostic interval
Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer
Time frame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
Duration of Pre-Treatment interval
Number of days from cancer diagnosis to cancer treatment
Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
Proportion of patients treated with limited stage cancer
Among patients with confirmed cancer, proportion treated with stage I/II disease
Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
Incidence of curative-intent treatment
Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment
Time frame: From intervention start up to trial end at 1825 days
Cancer presenting as emergency
Among patients with confirmed cancer, proportion of cancer cases presenting as emergency (inpatient admission or death within 1 week of presentation with symptom).
Time frame: From date of cancer diagnosis to date of cancer treatment up to 7 days
Incident low probability cancer syndromes
Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes
Time frame: Baseline
Final diagnosis within 8 weeks
Among patients with moderate to high probability cancer symptoms, proportion with cancer diagnosis or exclusion of cancer diagnosis within 8 weeks of initial clinic visit
Time frame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days
Incident invasive procedures in cancer suspects
Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes
Time frame: From intervention start up to trial end at 1825 days
Patients treated for cancer
Among patients with confirmed cancer, proportion of cancer cases receiving any cancer-specific therapy
Time frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
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