An interventional study of Clinic Outreach and Enhanced Outreach in Cervical Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 3 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 610 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be eligible if they:
Exclusion Criteria:
Patients will be excluded if they:
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
Behavioral: Clinic Outreach · Behavioral: Low-Touch Strategy
All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).
Behavioral: Clinic Outreach · Behavioral: High-Touch Strategy
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).
Behavioral: Enhanced Outreach · Behavioral: Low-Touch Strategy
All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.
Behavioral: Enhanced Outreach · Behavioral: High-Touch Strategy
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
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.
Adoption
Defined as the initiation of cervical cancer treatment within 90 days of randomization.
Time frame: Within 90 days of randomization
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
Reach: Results
Defined by the proportion of patients with confirmation of results received divided by those randomized.
Time frame: 12 months after randomization
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
Not enrolling at this site.
Plan to share: No
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Abramson Cancer Center at Penn Medicine →