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

Mass General Brigham

Status and phase: Enrolling; Phase 2

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

Treatments: Other: Potlako intervention; Other: Enhanced care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04141449

R01CA236546 (U.S. NIH Grant/Contract)

BHP0120

Details and patient eligibility

About

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 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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. Exclusion Criteria

      • Involuntary incarceration
      • Unable or unwilling to provide confirmation of informed consent
      • Already engaged in oncology care

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Potlako intervention

Experimental group

Description:

* 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.

Treatment:

Other: Potlako intervention

Enhanced Care

Active Comparator group

Description:

* 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.

Treatment:

Other: Enhanced care