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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Behavioral: Clinic Outreach; Behavioral: Low-Touch Strategy; Behavioral: High-Touch Strategy; Behavioral: Enhanced Outreach

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 Type: Interventional
• Enrollment (Estimated): 680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katharine Rendle, PhD,MSW,MPH; Phone Number: 215-349- 5442; Email: katharine.rendle@pennmedicine.upenn.edu
• Study Contact Backup: Name: Hannah Toneff, MSW, MA; Phone Number: 267-882-3186; Email: hannah.toneff@pennmedicine.upenn.edu

Study Locations

• Botswana
  • Gaborone, Botswana
    • Recruiting
    • Princess Marina Hospital
    • Principal Investigator: Surbhi Grover, MD, MPH
    • Contact: Surbhi Grover, MD, MPH; Email: Surbhi.Grover@pennmedicine.upenn.edu
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Active, not recruiting
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 Clinic Outreach + Stage 2 Low Touch; All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).	Behavioral: Clinic Outreach; A member of the pathology team will contact the referring clinic to communicate the readiness of results.; Behavioral: Low-Touch Strategy; Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.
Experimental: Stage 1 Clinic Outreach + Stage 2 High Touch; All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).	Behavioral: Clinic Outreach; A member of the pathology team will contact the referring clinic to communicate the readiness of results.; Behavioral: 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.
Experimental: Stage 1 Enhanced Outreach + Stage 2 Low-Touch; All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).	Behavioral: Low-Touch Strategy; Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.; Behavioral: Enhanced Outreach; A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.
Experimental: Stage 1 Enhanced Outreach + Stage 2 High-Touch; All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.	Behavioral: 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.; Behavioral: Enhanced Outreach; A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	Defined as the initiation of cervical cancer treatment within 90 days of randomization.	Within 90 days of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity	Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.	12 months after randomization
Reach: First Appointment	Defined by the proportion of patients who complete an initial treatment visit divided by those randomized	12 months after randomization
Reach: First Stage	Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.	12 months after randomization
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
Reach: Results	Defined by the proportion of patients with confirmation of results received divided by those randomized.	12 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes: Survival	Defined as overall survival at one year after randomization measured using medical record data.	12 months after randomization
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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Patient; Screening; Botswana
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: UPCC 23822; U01CA275032-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No