A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Overview

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.

Full Title of Study: “A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2025

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

  • Other: Potlako intervention
    • Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
  • Other: Enhanced care
    • Provider education and limited patient counseling.

Arms, Groups and Cohorts

  • Experimental: Potlako intervention
    • 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.
  • Active Comparator: Enhanced Care
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Duration of combined Appraisal and Help-seeking intervals
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
  • Incidence of curative-intent treatment
    • Time Frame: From intervention start up to trial end at 1825 days
    • Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment

Secondary Measures

  • Cancer presenting as emergency
    • Time Frame: 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
    • Time Frame: Baseline
    • Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes
  • Final diagnosis within 8 weeks
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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. Exclusion Criteria – Involuntary incarceration – Unable or unwilling to provide confirmation of informed consent – Already engaged in oncology care

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Botswana Harvard AIDS Institute Partnership
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott Lee Dryden-Peterson, Assistant Professor – Brigham and Women’s Hospital
  • Overall Official(s)
    • Scott Dryden-Peterson, MD, MSc, Principal Investigator, Brigham and Women’s Hospital, Botswana Harvard AIDS Institute
  • Overall Contact(s)
    • Kutlo Manyake, Dip Nursing, +267-3902671, kmanyake@bhp.org.bw

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