Brief Title
A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation
Official Title
A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Duration of combined Appraisal and Help-seeking intervals
Secondary Outcome
Cancer presenting as emergency
Condition
Neoplasms
Intervention
Potlako intervention
Study Arms / Comparison Groups
Potlako intervention
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
1500
Start Date
January 20, 2020
Completion Date
September 19, 2024
Primary Completion Date
January 20, 2024
Eligibility 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
Gender
All
Ages
30 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, ,
Location Countries
Botswana
Location Countries
Botswana
Administrative Informations
NCT ID
NCT04141449
Organization ID
BHP0120
Secondary IDs
R01CA236546
Responsible Party
Principal Investigator
Study Sponsor
Brigham and Women's Hospital
Collaborators
Botswana Harvard AIDS Institute Partnership
Study Sponsor
, ,
Verification Date
October 2019