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

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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)

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

Trial contacts and locations

1

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Central trial contact

Mompati Mmalane, MD; Kutlo Manyake, Dip Nursing

Data sourced from clinicaltrials.gov

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