Trial Outcomes & Findings for Implementation Strategies for Monitoring Adherence in Real Time (NCT NCT04347161)

Last Updated: 2026-03-04

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

75 participants

Primary outcome timeframe

12 weeks after study initiation or at therapy discontinuation, whichever is shorter

Results posted on

2026-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Conversational Agent/Chatbot (Intervention) 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.	Usual Care (Control) 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.
Overall Study STARTED	38	37
Overall Study COMPLETED	36	33
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Conversational Agent/Chatbot (Intervention) 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.	Usual Care (Control) 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.
Overall Study Death	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1
Overall Study No longer on study medication	1	1

Baseline Characteristics

Implementation Strategies for Monitoring Adherence in Real Time

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=38 Participants 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.	Control Arm n=37 Participants 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.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=41 Participants	20 Participants n=35 Participants	34 Participants n=76 Participants
Age, Categorical >=65 years	24 Participants n=41 Participants	17 Participants n=35 Participants	41 Participants n=76 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 2.4 • n=41 Participants	61.3 years STANDARD_DEVIATION 2.0 • n=35 Participants	62.3 years STANDARD_DEVIATION 1.5 • n=76 Participants
Sex: Female, Male Female	22 Participants n=41 Participants	26 Participants n=35 Participants	48 Participants n=76 Participants
Sex: Female, Male Male	16 Participants n=41 Participants	11 Participants n=35 Participants	27 Participants n=76 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=41 Participants	34 Participants n=35 Participants	70 Participants n=76 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=41 Participants	3 Participants n=35 Participants	5 Participants n=76 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants
Race (NIH/OMB) Asian	2 Participants n=41 Participants	1 Participants n=35 Participants	3 Participants n=76 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants
Race (NIH/OMB) Black or African American	3 Participants n=41 Participants	0 Participants n=35 Participants	3 Participants n=76 Participants
Race (NIH/OMB) White	33 Participants n=41 Participants	34 Participants n=35 Participants	67 Participants n=76 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	2 Participants n=35 Participants	2 Participants n=76 Participants
Region of Enrollment United States	38 participants n=41 Participants	37 participants n=35 Participants	75 participants n=76 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention Arm n=33 Participants 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.	Control Arm n=33 Participants 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.
Adherence	18 Participants	20 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Intervention Arm n=33 Participants 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.	Control Arm n=33 Participants 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.
Persistence	78.4 days Standard Error 2.3	79.8 days Standard Error 2.7

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Arm n=38 participants at risk 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.	Control Arm n=37 participants at risk 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.
Social circumstances Discomfort using technology	2.6% 1/38 • 12 week study duration	0.00% 0/37 • 12 week study duration

Additional Information

Katharine A Rendle, PhD,MSW,MPH

University of Pennsylvania

Phone: 215-349-5442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place