A Multilevel Intervention to Improve Timely Cancer Detection and Treatment Initiation

Breast Cancer Clinical Trial

— Potlako+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141449
• Other study ID #: BHP0120
• Secondary ID: R01CA236546
• Status: Recruiting
• Phase: Phase 2
• Start date: November 18, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: Kutlo Manyake, Dip Nursing
• Phone: +267-3902671
• Email: kmanyake[@]bhp.org.bw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Breast Cancer
• Cancer Suspect
• Cervical Cancer
• Hiv
• HNSCC
• Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Other:
• Potlako intervention
Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
• Enhanced care
Provider education and limited patient counseling.

Locations

Country	Name	City	State
Botswana	Botswana Harvard AIDS Institute	Gaborone

Sponsors (6)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Botswana Harvard AIDS Institute Partnership, Dana-Farber Cancer Institute, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey, University of Oxford

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Cancer presenting as emergency	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
Secondary	Incident low probability cancer syndromes	Cumulative incidence (cases per standardized population) of presentation with low probability cancer syndromes	Baseline
Secondary	Final diagnosis within 8 weeks	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
Secondary	Incident invasive procedures in cancer suspects	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
Secondary	Patients treated for cancer	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