Lung Cancer, Medication Adherence, Symptoms and Signs
Conditions
Keywords
medication adherence, symptom management, non-small cell lung cancer, implementation science, digital health, behavioral science
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.
Interventions
DEVICEConversational Agent/Chatbot
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 directly to the patients' cancer care team. Patients in the intervention arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
OTHERUsual 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.
Sponsors
Abramson Cancer Center at Penn Medicine
Lung Cancer Research Foundation
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (age \> 18 years) with NSCLC at UPHS who is receiving one of the following nine oral therapies: 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 "Penny" in English * Ability to provide informed consent to participate in the study * Approval from the patient's medical oncologist to be approached
Exclusion criteria
* Inability to respond to questions and engage with "Penny" 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 a therapeutic clinical trial * Taking more than one oral targeted therapy or concurrent chemotherapy during the study window * Lack of approval from the patient's oncologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 12 weeks after study initiation or at therapy discontinuation, whichever is shorter | Defined as number of patients who have 95% or greater adherent days across the study period based on their prescribed dose. Adherence data will be assessed via MEMS caps, which capture a date and time stamp each time the pill bottle is opened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence | 12 weeks after study initiation or at therapy discontinuation, whichever is shorter | Defined as the average number of total days on the regimen before discontinuation measured using MEMS caps across participants |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatharine A Rendle, PhD,MSW,MPH
University of Pennsylvania
PRINCIPAL_INVESTIGATORSamuel U Takvorian, MD, MSHP
University of Pennsylvania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Conversational Agent/Chatbot: 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 directly to the patients' cancer care team. Patients in the intervention arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys. | 38 |
| Control Arm Patients in the control arm will receive usual care, which includes clinician-driven education on medication management and self-monitoring of symptoms.
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. | 37 |
| Total | 75 |
Baseline characteristics
| Characteristic | Intervention Arm | Total | Control Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 41 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 34 Participants | 20 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 2.4 | 62.3 years STANDARD_DEVIATION 1.5 | 61.3 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 70 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 67 Participants | 34 Participants |
| Region of Enrollment United States | 38 participants | 75 participants | 37 participants |
| Sex: Female, Male Female | 22 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Male | 16 Participants | 27 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 2 / 37 |
| other Total, other adverse events | 1 / 38 | 0 / 37 |
| serious Total, serious adverse events | 0 / 38 | 0 / 37 |
Outcome results
Primary
Adherence
Defined as number of patients who have 95% or greater adherent days across the study period based on their prescribed dose. Adherence data will be assessed via MEMS caps, which capture a date and time stamp each time the pill bottle is opened.
Time frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
Population: Analysis population includes those patients with available adherence data (i.e., MEMS data successfully assessed).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Adherence | 18 Participants |
| Control Arm | Adherence | 20 Participants |
Secondary
Persistence
Defined as the average number of total days on the regimen before discontinuation measured using MEMS caps across participants
Time frame: 12 weeks after study initiation or at therapy discontinuation, whichever is shorter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Persistence | 78.4 days | Standard Error 2.3 |
| Control Arm | Persistence | 79.8 days | Standard Error 2.7 |