A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Phase 2

Recruiting

• Conditions: Neoplasms; Vulvar Cancer; Anal Cancer; Breast Cancer; Cancer Suspect; Hiv; HNSCC; Cervical Cancer

• Registration Number: NCT04141449
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Study Start: 2020-11-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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
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
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 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

Secondary Outcome Measures

Name	Time	Method
Incident low probability cancer syndromes	Baseline	Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes
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
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
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).

Trial Locations

Locations (1)

Botswana Harvard AIDS Institute; 🇧🇼 Gaborone, Botswana