Evaluation of the Cancer Tracking System (CATSystem)

Cervical Cancer Clinical Trial

— CATSystem  

Official title:

Implementing and Evaluating the Cancer Tracking System (CATSystem): A Systems Level Intervention to Improve Cervical Cancer Screening, Treatment Referral and Follow up in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286462
• Other study ID #: R01CA278617
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Catherine Wexler, MPH
• Phone: 913-945-7077
• Email: cwexler[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

Description:

To help address system level barriers to cervical cancer screening, treatment, and follow-up in Kenya, investigators worked with end-users (providers and patients) to develop the Cancer Tracking System (CATSystem), a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). Specific aims (SA) of the study are to (1) Implement and evaluate the efficacy of CATSystem to improve guideline adherent cervical cancer screening, treatment, referral and follow up, (2) Assess feasibility and acceptability of implementation of CATSystem in government run facilities using a human centered design approach, and (3) Calculate the costs and cost-effectiveness of the CATSystem to increase quality adjusted life years gained. Cervical cancer deaths can be prevented with early detection and treatment. This study will evaluate the public health impact of the CATSystem in improving cervical cancer screening, treatment, referral, follow-up, and the feasibility of scale up to other low resource settings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6600
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• women above 16 years of age

• access to a cell phone,

• presenting for cervical cancer screening at a study hospital.

Exclusion Criteria:

• greater than 20 weeks gestation,

• incarcerated patients,

• women who study staff feel are unable to provide written informed consent due to impaired capacity.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Cancer Tracking System (CATSystem)
The CATSystem provider dashboard highlights patients with overdue services or those in need of outreach and sends automated, customized texts to support screening and treatment follow-up per national guidelines. Points of intervention and alerts include: cervical cancer screening and treatment counseling, initial and follow up cervical cancer screening per national guidelines, treatment for precancer and cancer, referral tracking and follow up. In addition, the CATSystem can securely store images of the cervix taken with colposcopes to allow for remote expert consultation if needed to correctly diagnose a patient or can be reviewed at clinical team meetings for input. Primary goals of the CATSystem are to increase rates of guideline-adherent cervical cancer screening/ rescreening and improve guideline-adherent treatment, referral, and follow-up rates of women with positive screens.

Locations

Country	Name	City	State
Kenya	Akala Health Center	Akala
Kenya	Bondo Referral Hospital	Bondo
Kenya	Alupe Sub-County Hospital	Busia
Kenya	Busia County Referral Hospital	Busia
Kenya	Khunyangu Sub-County Hospital	Busia
Kenya	Matayos Health Center	Busia
Kenya	Port Victoria Sub-County Hospital	Busia
Kenya	Nambale Sub-County Hospital	Siaya
Kenya	Yala Sub-County Hospital	Siaya
Kenya	Ukwala Sub-County Hospital	Ukwala

Sponsors (5)

Lead Sponsor	Collaborator
University of Kansas Medical Center	DARTNet Institute, Global Health Innovations, San Diego State University, University of Michigan

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline adherent treatment for a positive screen	Provide guideline adherent treatment and rescreening for the range of possible positive screen results: cervicitis, precancerous lesions (mild, moderate, severe), invasive cervical cancer. Participants who receive the guideline adherent treatment for their positive screen result will be coded as 1 or "yes". Participants who do not receive the guideline adherent treatment for their positive screen will be coded as 0 or "no".	0-12 months [from screening result to treatment completion]
Primary	Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes	The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).	Years 2 and 3
Secondary	Cervical cancer screening	Compare the number of women screened for cervical cancer pre (12 month retrospective review of screening rates) and throughout the two-year enrollment period at all intervention and control sites.	0-24 months