A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation
Potlako+
A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
2 other identifiers
interventional
874
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedStudy Start
First participant enrolled
November 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
December 31, 2025
December 1, 2025
5.9 years
October 24, 2019
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Duration of combined Appraisal and Help-seeking intervals
Number of days from patient symptom awareness to first clinic visit, among patients with moderate or high probability of cancer
Baseline
Duration of Diagnostic interval
Number of days from first clinic visit to cancer diagnosis or diagnosis excluding cancer, among patients with moderate or high probability of cancer
From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
Duration of Pre-Treatment interval
Number of days from cancer diagnosis to cancer treatment
From date of cancer diagnosis to date of cancer treatment up to 365 days
Proportion of patients treated with limited stage cancer
Among patients with confirmed cancer, proportion treated with stage I/II disease
From date of cancer diagnosis to date of cancer treatment up to 365 days
Incidence of curative-intent treatment
Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment
From intervention start up to trial end at 1825 days
Secondary Outcomes (5)
Cancer presenting as emergency
From date of cancer diagnosis to date of cancer treatment up to 7 days
Incident low probability cancer syndromes
Baseline
Final diagnosis within 8 weeks
From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days
Incident invasive procedures in cancer suspects
From intervention start up to trial end at 1825 days
Patients treated for cancer
From date of cancer diagnosis to date of cancer treatment up to 365 days
Study Arms (2)
Potlako intervention
EXPERIMENTAL* 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.
Enhanced Care
ACTIVE COMPARATOR* 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.
Interventions
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
Eligibility Criteria
You may qualify if:
- Botswana citizen
- Age 30 years or older
- engaged in longitudinal care for chronic health problem
- resident of study community
You may not qualify if:
- Involuntary incarceration
- Educational messaging could interfere with clinical management or increase distress in the opinion or clinic or research staff
- Cancer suspects
- Botswana citizen
- Age 30 years or older
- resident of study community
- Recorded as a cancer suspect by clinic staff
- Involuntary incarceration
- Unable or unwilling to provide confirmation of informed consent
- Already engaged in oncology care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Botswana Harvard AIDS Institute Partnershipcollaborator
- Dana-Farber Cancer Institutecollaborator
- National Cancer Institute (NCI)collaborator
- Rutgers Cancer Institute of New Jerseycollaborator
Study Sites (1)
Botswana Harvard AIDS Institute
Gaborone, Botswana
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Dryden-Peterson, MD, MSc
Brigham and Women's Hospital, Botswana Harvard AIDS Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 24, 2019
First Posted
October 28, 2019
Study Start
November 18, 2020
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Following publication of primary study endpoints and for up to 5 years.
- Access Criteria
- IRB-approved (approval by Botswana Ministry of Health and Wellness required), cancer-related analyses consistent with informed consent document.
Data documentation and any de-identified information arising from this project will be deposited for sharing within the collaboration at a central secure, password protected electronic database managed initially by Botswana Harvard AIDS Institute with longer-term plans to move the database and responsibility for managing it to University of Botswana.