Clinical trial NCT05952141: Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
Official title: Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Screening
Botswana
Treatment
Patient
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Botswana
First posted: 2023-07-19
Enrollment: 680
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adoption
timeFrame: Within 90 days of randomization
Secondary outcomes:
measure: Fidelity
timeFrame: 12 months after randomization
measure: Reach: First Appointment
timeFrame: 12 months after randomization
measure: Reach: First Stage
timeFrame: 12 months after randomization
measure: Reach: Second Stage
timeFrame: 12 months after randomization
measure: Reach: Results
timeFrame: 12 months after randomization
Other outcomes:
measure: Clinical Outcomes: Treatment
timeFrame: 12 months after randomization
measure: Clinical Outcomes: Survival
timeFrame: 12 months after randomization
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Francistown
country: Botswana
facility: Nyangabgwe Referral Hospital
state: North East District
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: University of Pennsylvania
name: Katharine Rendle, PhD,MSW,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Surbhi Grover, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: