Clinical trial NCT04141449: A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation
Official title: A Multilevel Intervention (Potlako+) to Improve Timely Cancer Detection and Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neoplasms
Hiv
Cervical Cancer
Breast Cancer
HNSCC
Vulvar Cancer
Anal Cancer
Cancer Suspect
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Botswana Harvard AIDS Institute Partnership
name: Dana-Farber Cancer Institute
name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
name: University of Oxford
First posted: 2019-10-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired, community-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Duration of combined Appraisal and Help-seeking intervals
timeFrame: Baseline
measure: Duration of Diagnostic interval
timeFrame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 365 days
measure: Duration of Pre-Treatment interval
timeFrame: From date of cancer diagnosis to date of cancer treatment up to 365 days
measure: Proportion of patients treated with limited stage cancer
timeFrame: From date of cancer diagnosis to date of cancer treatment up to 365 days
measure: Incidence of curative-intent treatment
timeFrame: From intervention start up to trial end at 1825 days
Secondary outcomes:
measure: Cancer presenting as emergency
timeFrame: From date of cancer diagnosis to date of cancer treatment up to 7 days
measure: Incident low probability cancer syndromes
timeFrame: Baseline
measure: Final diagnosis within 8 weeks
timeFrame: From date of first clinic visit to date of cancer diagnosis or diagnosis excluding cancer, up to 56 days
measure: Incident invasive procedures in cancer suspects
timeFrame: From intervention start up to trial end at 1825 days
measure: Patients treated for cancer
timeFrame: From date of cancer diagnosis to date of cancer treatment up to 365 days
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Botswana Harvard AIDS Institute
Study officials:
affiliation: Brigham and Women's Hospital, Botswana Harvard AIDS Institute
name: Scott Dryden-Peterson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: