Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study

Not Applicable

Withdrawn

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Text Message-Based Navigation Intervention; Other: Behavioral, Psychological or Informational Intervention; Other: Survey Administration; Other: Quality-of-Life Assessment

• Registration Number: NCT05595135
• Lead Sponsor: Thomas Jefferson University

Brief Summary

This clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (AML). Medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a barrier to effective treatment. Collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to AML patients who are taking oral anti-cancer medications.

Detailed Description

PRIMARY OBJECTIVE:

I. To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.

SECONDARY OBJECTIVE:

I. To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.

EXPLORATORY OBJECTIVE:

I. To summarize and assess other patient-reported outcomes, collected either as patient chart review or through self-reported survey, as well as the patient post-intervention interviews.

OUTLINE:

Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.

Study Timeline

• Study Start: 2022-08-15
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-26
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients diagnosed with acute myeloid leukemia (AML)
• Patients will be or is taking venetoclax (or any other oral anticancer medication) as part of their first line therapy
• Has a phone with text capabilities
• Among patients aged 18 and older we will enroll participants regardless of race or ethnicity

Exclusion Criteria

• Individuals who are terminally ill (defined as having less than 2 months to live)
• Individuals for whom there is documentation of inability to provide consent in the medical record
• Do not speak/read English
• This study will exclude pediatric patients (defined as individuals under age 18 years)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health services research (text messages, smart pill bottle)	Text Message-Based Navigation Intervention	Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.
Health services research (text messages, smart pill bottle)	Survey Administration	Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.
Health services research (text messages, smart pill bottle)	Quality-of-Life Assessment	Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.
Health services research (text messages, smart pill bottle)	Behavioral, Psychological or Informational Intervention	Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.

Primary Outcome Measures

Name	Time	Method
Real-time oral anticancer medication (OAM) medication adherence	At 2 months	Will be measured daily by AdhereTech wireless smart pill bottles, which are Health Insurance Portability and Accountability Act (HIPAA)-compliant Food and Drug Administration (FDA) Class I medical devices that monitor electronic tracking of bottle and percent of pills detected inside the bottle. Will be summarized using proportions and 95% Clopper-Pearson exact confidence intervals.
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response	At 2 months	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.

Secondary Outcome Measures

Name	Time	Method
Complete remission (CR)	At baseline, 1, and 2 months	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence
Incomplete blood count recovery (Cri)	At baseline, 1, and 2 months	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
Partial remissions (PR)	At baseline, 1, and 2 months	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
Morphologic leukemia-free state (MLFS)	At baseline, 1, and 2 months	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.

Trial Locations

Locations (2)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States