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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA275032-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Botswana | OTHER |
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Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 Clinic Outreach + Stage 2 Low Touch | Experimental | 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). |
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| Stage 1 Clinic Outreach + Stage 2 High Touch | Experimental | 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). |
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| Stage 1 Enhanced Outreach + Stage 2 Low-Touch | Experimental | 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). |
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| Stage 1 Enhanced Outreach + Stage 2 High-Touch | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic Outreach | Behavioral | A member of the pathology team will contact the referring clinic to communicate the readiness of results. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adoption | Defined as the initiation of cervical cancer treatment within 90 days of randomization. | Within 90 days of randomization |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes: Treatment | Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., chemoradiation, surgery) measured using medical record data. | 12 months after randomization |
| Clinical Outcomes: Survival |
Inclusion Criteria:
Patients will be eligible if they:
Exclusion Criteria:
Patients will be excluded if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Rendle, PhD,MSW,MPH | Contact | 215-349- 5442 | katharine.rendle@pennmedicine.upenn.edu | |
| Hannah Toneff, MSW, MA | Contact | 267-882-3186 | hannah.toneff@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katharine Rendle, PhD,MSW,MPH | University of Pennsylvania | Principal Investigator |
| Surbhi Grover, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39533437 | Derived | Rendle KA, Ramogola-Masire D, Grover S; Thibang Diphatlha Collective. Thibang Diphatlha: a sequential multiple assignment randomized trial designed to increase timely adoption of cervical cancer treatment in Botswana. Implement Sci Commun. 2024 Nov 12;5(1):128. doi: 10.1186/s43058-024-00659-9. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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
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| Enhanced Outreach | Behavioral | A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results. |
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| Low-Touch Strategy | Behavioral | Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging. |
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| High-Touch Strategy | Behavioral | 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. |
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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 |
Defined as overall survival at one year after randomization measured using medical record data.
| 12 months after randomization |
| Nyangabgwe Referral Hospital |
| Recruiting |
| Francistown |
| North-East District |
| Botswana |
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| Princess Marina Hospital | Recruiting | Gaborone | Botswana |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |