Strategies to Close the Gap From CC Diagnosis to Treatment in Botswana

Cervical Cancer Clinical Trial

Official title:

Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952141
• Other study ID #: UPCC 23822
• Secondary ID: U01CA275032-01
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: November 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Katharine Rendle, PhD,MSW,MPH
• Phone: 215-349- 5442
• Email: katharine.rendle[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: August 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Clinic Outreach
A member of the pathology team will contact the referring clinic to communicate the readiness of results.
• Enhanced Outreach
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
Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
• High-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.

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI), University of Botswana

Countries where clinical trial is conducted

United States,  Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Outcomes: Treatment	Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., CRT, surgery) measured using medical record data.	12 months after randomization
Other	Clinical Outcomes: Survival	Defined as overall survival at one year after randomization measured using medical record data.	12 months after randomization
Primary	Adoption	Defined as the initiation of cervical cancer treatment within 90 days of randomization.	Within 90 days of randomization
Secondary	Fidelity	Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.	12 months after randomization
Secondary	Reach: First Appointment	Defined by the proportion of patients who complete an initial treatment visit divided by those randomized	12 months after randomization
Secondary	Reach: First Stage	Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.	12 months after randomization
Secondary	Reach: Second Stage	Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.	12 months after randomization
Secondary	Reach: Results	Defined by the proportion of patients with confirmation of results received divided by those randomized.	12 months after randomization