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Trial record 1 of 1 for:    NCT04347161
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Implementation Strategies for Monitoring Adherence in Real Time (iSMART)

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ClinicalTrials.gov Identifier: NCT04347161
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborators:
Lung Cancer Research Foundation
Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 15, 2020
Last Update Posted Date August 28, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Adherence [ Time Frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter ]
Defined as the number of adherent days divided by number of prescribed days. Adherent days will be calculated dichotomously based on whether a patient took all prescribed doses for the day within 2 hours of recommended time. Adherence data will be assessed via MEMS caps, which capture a date and time stamp each time the pill bottle is opened.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Persistence [ Time Frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter ]
Defined as the number of consecutive days on the regimen and conversely gaps in overall treatment, measured using MEMS caps.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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) to receive intervention or usual care.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Lung Cancer
  • Medication Adherence
  • Symptoms and Signs
Intervention  ICMJE
  • Behavioral: Conversational Agent
    Via text messages, the bidirectional, conversation agent provides specific dosing instructions and motivational reminders to promote oral targeted therapy adherence and symptom management. Patients can report symptoms at any time via text message and are also prompted to report symptoms and medication adherence at periodic intervals. Reported symptoms are monitored and managed algorithmically according severity. High-grade symptoms are triaged to the care team immediately. Patients in the intervention arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
  • Behavioral: Usual Care
    Patients in the control arm will receive usual care, which includes receiving information about dosing and self-administration of oral therapy, and anticipatory guidance for patients regarding management of side effects. Patients in the control arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
Study Arms  ICMJE
  • Experimental: Intervention Arm
    Participants in the intervention arm will be tracked and able to engage with the intervention (conversational agent) on their mobile telephone for 12 weeks.
    Intervention: Behavioral: Conversational Agent
  • Active Comparator: Control Arm
    Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.
    Intervention: Behavioral: Usual Care
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2020)
144
Original Estimated Enrollment  ICMJE Same as current
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:

  • 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, ceritinib, 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katharine A Rendle, PhD,MSW,MPH 215-662-9147 Katharine.Rendle@pennmedicine.upenn.edu
Contact: Jocelyn V Wainwright, MS 215-662-9128 Jocelyn.Wainwright@pennmedicine.upenn.edu
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 Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Lung Cancer Research Foundation
  • Pfizer
Investigators  ICMJE
Principal Investigator: Katharine A Rendle, PhD,MSW,MPH University of Pennsylvania
Principal Investigator: Samuel U Takvorian, MD, MSHP University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP