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

txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health services research (text messages, smart pill bottle); Patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Ancillary studies; Other: Text Message-Based Navigation Intervention; Receive interactive text messaging.; Other Names: Automated Text Message-Based Navigation; Text Message-Based Navigation; Other: Behavioral, Psychological or Informational Intervention; Receive medication reminders via smart pill bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-time oral anticancer medication (OAM) medication adherence	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.	At baseline
Real-time oral anticancer medication (OAM) medication adherence	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.	at 1 month
Real-time oral anticancer medication (OAM) medication adherence	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.	At 2 months
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.	At baseline
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.	At 1 month
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response	Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.	At 2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 22D.340; JT 19501 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No