Evaluation of the Cancer Tracking System (CATSystem)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2028-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Matched, cluster randomized controlled design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CATSystem Intervention

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.

Group Type EXPERIMENTAL

Cancer Tracking System (CATSystem)

Intervention Type OTHER

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.

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes