A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

NCT ID: NCT04141449

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

874 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Neoplasms Hiv Cervical Cancer Breast Cancer HNSCC Vulvar Cancer Anal Cancer Cancer Suspect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Paired, community-randomized trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Potlako intervention

Intervention Type OTHER

Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.

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.

Group Type ACTIVE_COMPARATOR

Enhanced care

Intervention Type OTHER

Provider education and limited patient counseling.

Interventions

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Potlako intervention

Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.

Intervention Type OTHER

Enhanced care

Provider education and limited patient counseling.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Botswana citizen
* Age 30 years or older
* engaged in longitudinal care for chronic health problem
* resident of study community

* Botswana citizen
* Age 30 years or older
* resident of study community
* Recorded as a cancer suspect by clinic staff

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


* Involuntary incarceration
* Unable or unwilling to provide confirmation of informed consent
* Already engaged in oncology care
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Botswana Harvard AIDS Institute Partnership

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Scott Lee Dryden-Peterson

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Dryden-Peterson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Botswana Harvard AIDS Institute

Locations

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Botswana Harvard AIDS Institute

Gaborone, , Botswana

Site Status

Countries

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Botswana

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA236546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BHP0120

Identifier Type: -

Identifier Source: org_study_id