Cervical Cancer
Conditions
Keywords
Screening, Botswana, Treatment, Patient
Brief summary
Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
Detailed description
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.
Interventions
BEHAVIORALClinic Outreach
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
BEHAVIORALEnhanced Outreach
A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
BEHAVIORALLow-Touch Strategy
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
BEHAVIORALHigh-Touch Strategy
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.
Sponsors
Abramson Cancer Center at Penn Medicine
National Cancer Institute (NCI)
University of Botswana
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Pragmatic Sequential Multiple Assignment Randomized Trial (SMART). This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible if they: 1. are biological females 2. are aged 18 or older 3. have pathology-confirmed invasive cervical cancer diagnosis 4. have pathology results evaluated at National Health Laboratory in Botswana 5. are citizens of Botswana 6. have no prior history of invasive cervical cancer
Exclusion criteria
Patients will be excluded if they: 1. are biological males or otherwise born without a cervix 2. are below the age of 18 due to the rarity of cervical cancer in this population 3. do not meet study inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption | Within 90 days of randomization | Defined as the initiation of cervical cancer treatment within 90 days of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity | 12 months after randomization | Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data. |
| Reach: First Appointment | 12 months after randomization | Defined by the proportion of patients who complete an initial treatment visit divided by those randomized |
| Reach: First Stage | 12 months after randomization | Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted. |
| Reach: Second Stage | 12 months after randomization | Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted. |
| Reach: Results | 12 months after randomization | Defined by the proportion of patients with confirmation of results received divided by those randomized. |
Countries
Botswana, United States
Contacts
CONTACTKatharine Rendle, PhD,MSW,MPH
CONTACTHannah Toneff, MSW, MA
PRINCIPAL_INVESTIGATORKatharine Rendle, PhD,MSW,MPH
University of Pennsylvania
PRINCIPAL_INVESTIGATORSurbhi Grover, MD, MPH
University of Pennsylvania
Outcome results
None listed