A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

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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

November 18, 2020

Completion Date

September 19, 2024

Primary Completion Date

March 31, 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

Scott Dryden-Peterson, MD, MSc, +267-3902671, [email protected]

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

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


Verification Date

September 2021