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

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ClinicalTrials.gov Identifier: NCT05952141
Recruitment Status : Recruiting
First Posted : July 19, 2023
Last Update Posted : November 14, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Botswana
Information provided by (Responsible Party):
Katharine Rendle, Abramson Cancer Center at Penn Medicine

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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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: Enhanced Outreach
A member of the pathology team will contact both the referring clinic and the patient directly 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 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: Enhanced Outreach
A member of the pathology team will contact both the referring clinic and the patient directly 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.


Outcome Measures
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Primary Outcome Measures :
  1. Adoption [ Time Frame: Within 90 days of randomization ]
    Defined as the initiation of cervical cancer treatment within 90 days of randomization.


Secondary Outcome Measures :
  1. Fidelity [ Time Frame: 12 months after randomization ]
    Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.

  2. Reach: First Appointment [ Time Frame: 12 months after randomization ]
    Defined by the proportion of patients who complete an initial treatment visit divided by those randomized

  3. Reach: First Stage [ Time Frame: 12 months after randomization ]
    Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.

  4. Reach: Second Stage [ Time Frame: 12 months after randomization ]
    Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.

  5. Reach: Results [ Time Frame: 12 months after randomization ]
    Defined by the proportion of patients with confirmation of results received divided by those randomized.


Other Outcome Measures:
  1. Clinical Outcomes: Treatment [ Time Frame: 12 months after randomization ]
    Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., CRT, surgery) measured using medical record data.

  2. Clinical Outcomes: Survival [ Time Frame: 12 months after randomization ]
    Defined as overall survival at one year after randomization measured using medical record data.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952141


Contacts
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Contact: Katharine Rendle, PhD,MSW,MPH 215-349- 5442 katharine.rendle@pennmedicine.upenn.edu
Contact: Hannah Toneff, MSW, MA 267-882-3186 hannah.toneff@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Botswana
Princess Marina Hospital Recruiting
Gaborone, Botswana
Contact: Surbhi Grover, MD, MPH       Surbhi.Grover@pennmedicine.upenn.edu   
Principal Investigator: Surbhi Grover, MD, MPH         
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
National Cancer Institute (NCI)
University of Botswana
Investigators
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Principal Investigator: Katharine Rendle, PhD,MSW,MPH University of Pennsylvania
Principal Investigator: Surbhi Grover, MD, MPH University of Pennsylvania
More Information
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Responsible Party: Katharine Rendle, Principal Investigator, Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT05952141    
Other Study ID Numbers: UPCC 23822
U01CA275032-01 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: November 14, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katharine Rendle, Abramson Cancer Center at Penn Medicine:
Screening
Botswana
Treatment
Patient
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases