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

NCT ID: NCT05595135

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-05-05

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Text Message-Based Navigation Intervention

Intervention Type OTHER

Receive interactive text messaging.

Behavioral, Psychological or Informational Intervention

Intervention Type OTHER

Receive medication reminders via smart pill bottle

Survey Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Text Message-Based Navigation Intervention

Receive interactive text messaging.

Intervention Type OTHER

Behavioral, Psychological or Informational Intervention

Receive medication reminders via smart pill bottle

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Automated Text Message-Based Navigation Text Message-Based Navigation Quality of Life Assessment

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JT 19501

Identifier Type: OTHER

Identifier Source: secondary_id

22D.340

Identifier Type: -

Identifier Source: org_study_id

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