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

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Thomas Jefferson University

Status

Withdrawn

Conditions

Acute Myeloid Leukemia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05595135
JT 19501 (Other Identifier)
22D.340

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

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

Trial contacts and locations

2

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Central trial contact

Kuang-Yi Wen

Data sourced from clinicaltrials.gov

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