Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

ConditionCervical Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorAbramson Cancer Center at Penn Medicine

About this trial

Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

are biological females

are aged 18 or older

have pathology-confirmed invasive cervical cancer diagnosis

have pathology results evaluated at National Health Laboratory in Botswana

Disqualifiers

are biological males or otherwise born without a cervix

are below the age of 18 due to the rarity of cervical cancer in this population

do not meet study inclusion criteria

Trial design

Design model

Sequential

Treatments tested in this trial

Clinic Outreach
Behavioral
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
Enhanced Outreach
Behavioral
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
Low-Touch Strategy
Behavioral
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
High-Touch Strategy
Behavioral
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging in combination with synchronous telephone-based patient navigation.

Treatment groups

610 Participants

are divided into 4 treatment groups

Group A: Stage 1 Clinic Outreach + Stage 2 Low TouchExperimental treatment 2 interventions

Group B: Stage 1 Clinic Outreach + Stage 2 High TouchExperimental treatment 2 interventions

Group C: Stage 1 Enhanced Outreach + Stage 2 Low-TouchExperimental treatment 2 interventions

Group D: Stage 1 Enhanced Outreach + Stage 2 High-TouchExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Adoption

Defined as the initiation of cervical cancer treatment within 90 days of randomization.

Time frame

Within 90 days of randomization

Secondary outcomes

Fidelity

Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.

Time frame

12 months after randomization

Reach: First Appointment

Defined by the proportion of patients who complete an initial treatment visit divided by those randomized

Time frame

12 months after randomization

Reach: First Stage

Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.

Time frame

12 months after randomization

Reach: Second Stage

Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.

Time frame

12 months after randomization

Other outcomes

Clinical Outcomes: Treatment

Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., chemoradiation, surgery) measured using medical record data.

Time frame

12 months after randomization

Clinical Outcomes: Survival

Defined as overall survival at one year after randomization measured using medical record data.

Time frame

12 months after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Botswana

Collaborator

Source ClinicalTrials.gov

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