Clinical trial NCT05595135: Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study
Official title: txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Real-time oral anticancer medication (OAM) medication adherence
timeFrame: At baseline
measure: Real-time oral anticancer medication (OAM) medication adherence
timeFrame: at 1 month
measure: Real-time oral anticancer medication (OAM) medication adherence
timeFrame: At 2 months
measure: MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
timeFrame: At baseline
measure: MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
timeFrame: At 1 month
measure: MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
timeFrame: At 2 months
Secondary outcomes:
measure: Complete remission (CR)
timeFrame: At baseline, 1, and 2 months
measure: Incomplete blood count recovery (Cri)
timeFrame: At baseline, 1, and 2 months
measure: Partial remissions (PR)
timeFrame: At baseline, 1, and 2 months
measure: Morphologic leukemia-free state (MLFS)
timeFrame: At baseline, 1, and 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References: