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

July 31, 2023 updated by: Scott Lee Dryden-Peterson, Brigham and Women's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Botswana
      • Gaborone, Botswana
        • Recruiting
        • Botswana Harvard AIDS Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Potlako intervention
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
Active Comparator: 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.
Other: Enhanced care
Provider education and limited patient counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of combined Appraisal and Help-seeking intervals
Time Frame: Baseline
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
Time Frame: 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
From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
Duration of Pre-Treatment interval
Time Frame: From date of cancer diagnosis to date of cancer treatment up to 365 days
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
Time Frame: 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
From date of cancer diagnosis to date of cancer treatment up to 365 days
Incidence of curative-intent treatment
Time Frame: From intervention start up to trial end at 1825 days
Cumulative incidence (cases per standardized population) of initiation of curative-intent cancer treatment
From intervention start up to trial end at 1825 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer presenting as emergency
Time Frame: 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).
From date of cancer diagnosis to date of cancer treatment up to 7 days
Incident low probability cancer syndromes
Time Frame: Baseline
Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes
Baseline
Final diagnosis within 8 weeks
Time Frame: 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
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
Time Frame: 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
From intervention start up to trial end at 1825 days
Patients treated for cancer
Time Frame: 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
From date of cancer diagnosis to date of cancer treatment up to 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Cancer Institute (NCI)
Dana-Farber Cancer Institute
University of Oxford
Rutgers Cancer Institute of New Jersey
Botswana Harvard AIDS Institute Partnership

Investigators

  • Principal Investigator: Scott Dryden-Peterson, MD, MSc, Brigham and Women's Hospital, Botswana Harvard AIDS Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHP0120
  • R01CA236546 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Following publication of primary study endpoints and for up to 5 years.

IPD Sharing Access Criteria

IRB-approved (approval by Botswana Ministry of Health and Wellness required), cancer-related analyses consistent with informed consent document.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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