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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05595135
• Other study ID #: 22D.340
• Status: Withdrawn
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: July 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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