Anal Cancer, Breast Cancer, Cancer Suspect, Cervical Cancer, Hiv, HNSCC, Neoplasms, Vulvar Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERPotlako intervention
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
OTHEREnhanced care
Provider education and limited patient counseling.
Sponsors
Botswana Harvard AIDS Institute Partnership
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Paired, community-randomized trial
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Community members 1. Inclusion Criteria: * Botswana citizen * Age 30 years or older * engaged in longitudinal care for chronic health problem * resident of study community 2.
Exclusion criteria
* Involuntary incarceration * Educational messaging could interfere with clinical management or increase distress in the opinion or clinic or research staff 2. Cancer suspects 1. Inclusion Criteria: * Botswana citizen * Age 30 years or older * resident of study community * Recorded as a cancer suspect by clinic staff 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of curative-intent treatment | From intervention start up to trial end at 1825 days | Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment |
| Duration of combined Appraisal and Help-seeking intervals | Baseline | Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer |
| Duration of Diagnostic interval | 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 |
| Duration of Pre-Treatment interval | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer presenting as emergency | From date of cancer diagnosis to date of cancer treatment up to 7 days | Among patients with confirmed cancer, proportion of cancer cases presenting as emergency (inpatient admission or death within 1 week of presentation with symptom). |
| Incident low probability cancer syndromes | Baseline | Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes |
| Final diagnosis within 8 weeks | From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days | 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 |
| Incident invasive procedures in cancer suspects | From intervention start up to trial end at 1825 days | Cumulative incidence (cases per standardized population) of presentation with low, moderate, or high probability cancer syndromes |
| Patients treated for cancer | From date of cancer diagnosis to date of cancer treatment up to 365 days | Among patients with confirmed cancer, proportion of cancer cases receiving any cancer-specific therapy |
Countries
Botswana
Outcome results
None listed