Acute Myeloid LeukemiaNCT05595135
Mobile Intervention to Improve Adherence of Oral Anti-cancer Medications Among Acute Myeloid Leukemia Patients, the txt4AML Study
A study testing Text Message-Based Navigation Intervention, Behavioral, Psychological or Informational Intervention and Survey Administration in people with Acute Myeloid Leukemia, run by Thomas Jefferson University at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Text Message-Based Navigation Intervention, Behavioral, Psychological or Informational Intervention and Survey Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2022to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.
SECONDARY OBJECTIVE:
- To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.
EXPLORATORY OBJECTIVE:
- 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
- Acute Myeloid Leukemia
- Being tested
- Text Message-Based Navigation Intervention, Behavioral, Psychological or Informational Intervention, Survey Administration, Quality-of-Life Assessment
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive interactive text messaging.
Behavioral, Psychological or Informational InterventionOther
Receive medication reminders via smart pill bottle
Survey AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Text Message-Based Navigation Intervention; Other: Behavioral, Psychological or Informational Intervention; Other: Survey Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 2 months
Secondary outcomes (4)
Complete remission (CR)
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence
Measured: At baseline, 1, and 2 months
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.
Measured: At baseline, 1, and 2 months
Partial remissions (PR)
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
Measured: At baseline, 1, and 2 months
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.
Measured: At baseline, 1, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start15 Aug 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595135
- Sponsor's protocol ID
- 22D.340
- Other IDs
- JT 19501
- Status last verified
- Apr 2025
- First submitted
- 18 Oct 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- txt4AML: An Innovative Mobile Intervention to Improve Oral Anti-Cancer Medications Among Acute Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT05595135
- Acronym / sponsor ID
- 22D.340
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: staffing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine the feasibility, acceptability and preliminary efficacy of txt4AML in a pilot single arm study.
SECONDARY OBJECTIVE:
- To explore the association between overall treatment responses and real-time oral anti-cancer medication (OAM) adherence.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (text messages, smart pill bottle) | Experimental | Other: Text Message-Based Navigation Intervention, Other: Behavioral, Psychological or Informational Intervention, Other: Survey Administration, Other: Quality-of-Life AssessmentPatients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive interactive text messaging. | Other | Health services research (text messages, smart pill bottle) |
| Behavioral, Psychological or Informational InterventionReceive medication reminders via smart pill bottle | Other | Health services research (text messages, smart pill bottle) |
| Survey AdministrationAncillary studies | Other | Health services research (text messages, smart pill bottle) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Health services research (text messages, smart pill bottle) |
Primary outcome
Real-time oral anticancer medication (OAM) medication adherence
Time frame: At baseline
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.
Real-time oral anticancer medication (OAM) medication adherence
Time frame: at 1 month
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.
Real-time oral anticancer medication (OAM) medication adherence
Time frame: At 2 months
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.
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
Time frame: At baseline
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
Time frame: At 1 month
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
MD Anderson Symptom Inventory for acute myeloid leukemia/myelodysplastic syndrome (MDASI)-(AML)/MDS survey response
Time frame: At 2 months
Will be analyzed using univariable logistic regression models with the primary predictor of averaged daily real-time OAM medication adherence.
4 secondary outcomes
Complete remission (CR)
Time frame: At baseline, 1, and 2 months
Incomplete blood count recovery (Cri)
Time frame: At baseline, 1, and 2 months
Partial remissions (PR)
Time frame: At baseline, 1, and 2 months
Morphologic leukemia-free state (MLFS)
Time frame: At baseline, 1, and 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message-Based Navigation Intervention, Behavioral, Psychological or Informational Intervention and Survey Administration in people with Acute Myeloid Leukemia, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time oral anticancer medication (OAM) medication adherence (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.