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

Sponsor

Abramson Cancer Center at Penn Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05952141

Collaborator

National Cancer Institute (NCI) (NIH), University of Botswana (Other)

680

Enrollment

Locations

Arms

Anticipated Duration (Months)

340

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Behavioral: Clinic Outreach Behavioral: Enhanced Outreach Behavioral: Low-Touch Strategy Behavioral: High-Touch Strategy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

680 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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 interventionsPragmatic 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

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stage 1 Clinic Outreach A member of the pathology team will contact the referring clinic where the patient had the diagnostic procedure to communicate positive results and provide an appointment at a gynecological cancer treatment clinic.	Behavioral: Clinic Outreach A member of the pathology team will only contact the referring clinic.
Experimental: Stage 1 Enhanced Outreach A member of the pathology team will contact the referring clinic where the patient had the diagnostic procedure to communicate positive results and provide an appointment at a gynecological cancer treatment clinic. In the enhanced outreach arm, the patient will also be contacted directly by the pathology team and informed that their results are ready.	Behavioral: Enhanced Outreach A member of the pathology team will contact both the referring clinic and the patient directly.
Experimental: Stage 2 Low-Touch Individuals who do not complete an initial visit at the cancer treatment clinic within 30 days of randomization (non-responders) will be randomized to receive asynchronous text message reminders using framed messaging alone.	Behavioral: Low-Touch Strategy Asynchronous text messaging reminders using framed messaging.
Experimental: Stage 2 High-Touch Individuals who do not complete an initial visit at the cancer treatment clinic within 30 days of randomization (non-responders) will be randomized to receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.	Behavioral: High-Touch Strategy Asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.

Outcome Measures

Primary Outcome Measures

Adoption [Within 90 days of randomization]
Defined as the initiation of cervical cancer treatment within 90 days of randomization.

Secondary Outcome Measures

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.

Other Outcome Measures

Clinical Outcomes: Treatment [12 months after randomization]
Defined by the type of cancer treatment the patient received (e.g., CRT, surgery) measured using medical record data.
Clinical Outcomes: Survival [12 months after randomization]
Defined as overall survival at one year after randomization measured using medical record data.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients will be eligible if they:

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

Exclusion Criteria:

Patients will be excluded if they:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Princess Marina Hospital	Gaborone		Botswana

Sponsors and Collaborators

Abramson Cancer Center at Penn Medicine
National Cancer Institute (NCI)
University of Botswana

Investigators

Principal Investigator: Katharine Rendle, PhD,MSW,MPH, University of Pennsylvania
Principal Investigator: Surbhi Grover, MD, MPH, University of Pennsylvania