Implementation Strategies for Monitoring Adherence in Real Time
NCT04347161
ABOUT THIS STUDY
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- Adult patient with advanced NSCLC who is receiving care at a recruiting site and is taking an FDA-approved oral targeted therapies including but not limited to: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, alectinib, brigatinib, crizotinib, or lorlatinib.
- Patient possession of a mobile device that can send/receive SMS texts
- Ability to respond to questions and engage with text messages in English
- Ability to provide informed consent to participate in the study
- Inability to respond to questions and engage with text messages in English
- Inability or unwillingness to provide informed consent to participate in the study
- Inability to engage with SMS text-messaging platform
- Concurrent enrollment in another clinical trial involving oral targeted therapies or
adherence to care
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Descriptive Information | |||||||||
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Brief Title ICMJE | Implementation Strategies for Monitoring Adherence in Real Time | ||||||||
Official Title ICMJE | Implementation Strategies for Monitoring Adherence in Real Time | ||||||||
Brief Summary | The objective of this project is to identify effective strategies to help patients with lung cancer manage side effects and achieve optimal adherence to oral targeted therapies. To achieve this objective, we will evaluate the effect of a novel, bidirectional conversational agent, compared to usual care, on adherence to oral targeted therapies using a two-arm randomized controlled trial, and explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from clinicians and patients. | ||||||||
Detailed Description | Drawing from insights in behavioral economics and implementation science, the goal of our project is to identify effective strategies for improving lung cancer outcomes by helping patients to better manage symptoms and adhere to oral therapies. Given the rapid increase in FDA-approved targeted therapies, the need for such strategies will continue to grow. Our central hypothesis is that conversational agent will improve adherence to oral therapies by targeting patient-level determinants of behavior change. The specific aims are to: 1) Test the effects of a patient-directed intervention (conversational agent) to improve adherence to oral targeted therapies in patients with non-small cell lung cancer.; and 2) Use mixed-methods approaches with clinicians and patients to explore multilevel factors shaping the acceptability, effectiveness, and future implementation of intervention into routine cancer care. Primary trial outcomes (adherence and persistence) will be measured using microelectronic monitoring system (MEMS) caps. Secondary outcomes will be assessed using longitudinal surveys and medical record data. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients with lung cancer receiving oral targeted therapies at recruitment sites will be randomized (1:1 stratified by drug class and prescription status) to receive intervention or usual care. Masking: Single (Outcomes Assessor)Masking Description: Due to the nature of the intervention, participants and their care providers (including investigators) will not be blinded. The primary analyst and outcomes assessor will be blinded. Blinding may be broken in an emergency. Primary Purpose: Supportive Care
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 170 | ||||||||
Original Estimated Enrollment ICMJE | 144 | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04347161 | ||||||||
Other Study ID Numbers ICMJE | 834713 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Pennsylvania | ||||||||
Study Sponsor ICMJE | University of Pennsylvania | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Pennsylvania | ||||||||
Verification Date | February 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |