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

NCT05595135 | Withdrawn DMC

• 2 other identifiers: 22D.340JT 19501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Complete remission (CR)

  At baseline, 1, and 2 months

• Incomplete blood count recovery (Cri)

  At baseline, 1, and 2 months

• Partial remissions (PR)

  At baseline, 1, and 2 months

• Morphologic leukemia-free state (MLFS)

  At baseline, 1, and 2 months

Study Arms (1)

Health services research (text messages, smart pill bottle)

EXPERIMENTAL

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

Other: Text Message-Based Navigation Intervention; Other: Behavioral, Psychological or Informational Intervention; Other: Survey Administration; Other: Quality-of-Life Assessment

Interventions

Text Message-Based Navigation Intervention OTHER

Receive interactive text messaging.

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Health services research (text messages, smart pill bottle)

Behavioral, Psychological or Informational Intervention OTHER

Receive medication reminders via smart pill bottle

Health services research (text messages, smart pill bottle)

Survey Administration OTHER

Ancillary studies

Health services research (text messages, smart pill bottle)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Health services research (text messages, smart pill bottle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 26, 2022
• Study Start: August 15, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (2)