A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation (Potlako+)

Botswana Harvard AIDS Institute Partnership, Dana-Farber Cancer Institute, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey, University of Oxford

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.

Provider oncology training focused on detection of cancer symptoms/signs and performance of appropriate diagnostic evaluation Community-led cancer symptom awareness campaign to educate residents on methods and importance of early detection of cancer Support/counselling call after initial clinician recognition that patient requires evaluation for possible cancer. Cross-sectional community-facing activities partnered with longitudinal clinic-based targeted educational program Remote phone/SMS-based cancer suspect navigation program to support and expedite evaluation for symptoms/signs of possible cancer.

Provider oncology training focused on detection of cancer symptoms/signs and performance of appropriate diagnostic evaluation. Support/counselling call after initial clinician recognition that patient requires evaluation for possible cancer.

Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer

Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer

From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days

Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment

Among patients with confirmed cancer, proportion of cancer cases presenting as emergency (inpatient admission or death within 1 week of presentation with symptom).

Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes

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

From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days

Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes

Among patients with confirmed cancer, proportion of cancer cases receiving any cancer-specific therapy

Community members Inclusion Criteria: Botswana citizen Age 30 years or older engaged in longitudinal care for chronic health problem resident of study community Exclusion Criteria: 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

Data documentation and any de-identified information arising from this project will be deposited for sharing within the collaboration at a central secure, password protected electronic database managed initially by Botswana Harvard AIDS Institute with longer-term plans to move the database and responsibility for managing it to University of Botswana.

IRB-approved (approval by Botswana Ministry of Health and Wellness required), cancer-related analyses consistent with informed consent document.