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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinic Outreach
Enhanced Outreach
Low-Touch Strategy
High-Touch Strategy
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cervical Cancer focused on measuring Screening, Botswana, Treatment, Patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Pennsylvania
  • Princess Marina HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1 Clinic Outreach

Stage 1 Enhanced Outreach

Stage 2 Low-Touch

Stage 2 High-Touch

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fidelity
Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.
Reach: First Appointment
Defined by the proportion of patients who complete an initial treatment visit divided by those randomized
Reach: First Stage
Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.
Reach: Second Stage
Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.
Reach: Results
Defined by the proportion of patients with confirmation of results received divided by those randomized.

Full Information

First Posted
July 11, 2023
Last Updated
October 9, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI), University of Botswana
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1. Study Identification

Unique Protocol Identification Number
NCT05952141
Brief Title
Strategies to Close the Gap From CC 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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI), University of Botswana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Screening, Botswana, Treatment, Patient

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Clinic Outreach
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 1 Enhanced Outreach
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2 Low-Touch
Arm Type
Experimental
Arm Description
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.
Arm Title
Stage 2 High-Touch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinic Outreach
Intervention Description
A member of the pathology team will only contact the referring clinic.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Outreach
Intervention Description
A member of the pathology team will contact both the referring clinic and the patient directly.
Intervention Type
Behavioral
Intervention Name(s)
Low-Touch Strategy
Intervention Description
Asynchronous text messaging reminders using framed messaging.
Intervention Type
Behavioral
Intervention Name(s)
High-Touch Strategy
Intervention Description
Asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.
Primary Outcome Measure Information:
Title
Adoption
Description
Defined as the initiation of cervical cancer treatment within 90 days of randomization.
Time Frame
Within 90 days of randomization
Secondary Outcome Measure Information:
Title
Fidelity
Description
Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.
Time Frame
12 months after randomization
Title
Reach: First Appointment
Description
Defined by the proportion of patients who complete an initial treatment visit divided by those randomized
Time Frame
12 months after randomization
Title
Reach: First Stage
Description
Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.
Time Frame
12 months after randomization
Title
Reach: Second Stage
Description
Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.
Time Frame
12 months after randomization
Title
Reach: Results
Description
Defined by the proportion of patients with confirmation of results received divided by those randomized.
Time Frame
12 months after randomization
Other Pre-specified Outcome Measures:
Title
Clinical Outcomes: Treatment
Description
Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., CRT, surgery) measured using medical record data.
Time Frame
12 months after randomization
Title
Clinical Outcomes: Survival
Description
Defined as overall survival at one year after randomization measured using medical record data.
Time Frame
12 months after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katharine Rendle, PhD,MSW,MPH
Phone
215-349- 5442
Email
katharine.rendle@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Toneff, MSW, MA
Phone
267-882-3186
Email
hannah.toneff@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Rendle, PhD,MSW,MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Surbhi Grover, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Princess Marina Hospital
City
Gaborone
Country
Botswana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surbhi Grover, MD, MPH
Email
Surbhi.Grover@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Surbhi Grover, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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

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