A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neoplasms, Hiv, Cervical Cancer, Breast Cancer, HNSCC, Vulvar Cancer, Anal Cancer, Cancer Suspect

Intervention / Treatment
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* Other: Potlako intervention
* Other: Enhanced care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Paired, community-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potlako intervention<br>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. | Other: Potlako intervention<br>* Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.<br>|
| Active Comparator: Enhanced Care<br>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. | Other: Enhanced care<br>* Provider education and limited patient counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | From intervention start up to trial end at 1825 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | 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 | 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 | From date of cancer diagnosis to date of cancer treatment up to 365 days |