This clinical trial tests strategies to increase timely adoption of cervical cancer treatment in Botswana. Delays and missed opportunities for timely treatment contribute significantly to unfavorable outcomes in cervical cancer. There is a critical need to identify effective strategies to ensure timely care. Four different strategies including clinic outreach alone or in combination with direct patient outreach and asynchronous nudges using framed messages alone or in combination with synchronous patient navigation will be tested and may help to increase timely adoption of cervical cancer treatment in Botswana. Enhancing coordination, communication, and navigation through centralized outreach and nudge strategies may increase timely treatment adoption for cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05952141.
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PRIMARY OBJECTIVE:
I. To compare the effectiveness of four adaptive telehealth strategies on timely treatment adoption in females with invasive cervical cancer in Botswana using a pragmatic sequential multiple assignment randomized trial (SMART) design.
SECONDARY OBJECTIVE:
I. To evaluate multilevel mechanisms contributing to the effectiveness of adaptive strategies using surveys and mixed methods interviews with patients and clinicians.
OUTLINE:
STAGE 1: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive direct clinic outreach to communicate readiness of cervical cancer results. The pathology team contacts the referring clinic where the patient had the diagnostic procedure to communicate cervical cancer positive results and provide a scheduled appointment at the multidisciplinary team treatment clinic or Nyangabgwe Referral Hospital (NRH) oncology visit.
ARM II: Patients receive direct clinic outreach to communicate readiness of cervical cancer results. The pathology team contacts the referring clinic where the patient had the diagnostic procedure to communicate cervical cancer positive results and provide a scheduled appointment at the multidisciplinary team treatment clinic or NRH oncology and the patient is also notified directly by the pathology team.
STAGE 2: Patients who do not complete an initial visit at the multidisciplinary team treatment clinic or NRH oncology visit within 30 days of outreach are randomized to 1 of 2 arms.
ARM III: Patients receive a nudge consisting of messaging via text message and/or voice calls within 1 week of randomization and patients will be asked to confirm receipt.
ARM IV: Patients receive a nudge consisting of calls by a patient navigator within 1 week of randomization to talk through any questions they have about their diagnosis and to help mitigate any barriers to attending their scheduled visit including transportation, childcare, or other support for patients who may need it. Patients are contacted up to 3 times at varying times of the day and week until they are reached or lost to follow-up.
After initial randomization, patients are followed up for 12 months.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorKatharine Rendle
