Evaluation of the Cancer Tracking System (CATSystem)

University of Kansas

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: Cancer Tracking System (CATSystem)

Study type: Interventional

Funder types: Other

Identifiers

NCT06286462

R01CA278617

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6,600 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,600 participants in 2 patient groups

CATSystem Intervention

Experimental group

Description:

Participants enrolled at intervention sites will receive CATSytem-supported cervical cancer screening and treatment services. Interventions received will include: text messages to patients and algorithm-driven alerts to providers when guideline-adherent cervical cancer screening and treatment services are required including: initial and follow up cervical cancer screening, on site treatment, and referral tracking.

Treatment:

Other: Cancer Tracking System (CATSystem)

Standard of care

No Intervention group

Description:

Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up