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Trial Title:
Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana
NCT ID:
NCT05952141
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Screening
Botswana
Treatment
Patient
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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 interventions
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Clinic Outreach
Description:
A member of the pathology team will contact the referring clinic to communicate the
readiness of results.
Arm group label:
Stage 1 Clinic Outreach + Stage 2 High Touch
Arm group label:
Stage 1 Clinic Outreach + Stage 2 Low Touch
Intervention type:
Behavioral
Intervention name:
Enhanced Outreach
Description:
A member of the pathology team will contact both the referring clinic and the patient
directly to communicate the readiness of results.
Arm group label:
Stage 1 Enhanced Outreach + Stage 2 High-Touch
Arm group label:
Stage 1 Enhanced Outreach + Stage 2 Low-Touch
Intervention type:
Behavioral
Intervention name:
Low-Touch Strategy
Description:
Patient will be sent asynchronous text messaging reminders related to the importance of
timely care using framed messaging.
Arm group label:
Stage 1 Clinic Outreach + Stage 2 Low Touch
Arm group label:
Stage 1 Enhanced Outreach + Stage 2 Low-Touch
Intervention type:
Behavioral
Intervention name:
High-Touch Strategy
Description:
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.
Arm group label:
Stage 1 Clinic Outreach + Stage 2 High Touch
Arm group label:
Stage 1 Enhanced Outreach + Stage 2 High-Touch
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Nyangabgwe Referral Hospital
Address:
City:
Francistown
Country:
Botswana
Status:
Not yet recruiting
Contact:
Last name:
Surbhi Grover, MD
Phone:
2672076977
Email:
surbhi.grover@pennmedicine.upenn.edu
Contact backup:
Last name:
Irene Ramokate
Email:
ramokatei@bup.org.bw
Facility:
Name:
Princess Marina Hospital
Address:
City:
Gaborone
Country:
Botswana
Status:
Recruiting
Contact:
Last name:
Surbhi Grover, MD, MPH
Email:
Surbhi.Grover@pennmedicine.upenn.edu
Investigator:
Last name:
Surbhi Grover, MD, MPH
Email:
Principal Investigator
Start date:
September 1, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
University of Botswana
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05952141
