Chronic Myelogenous Leukemia, BCR-ABL1 PositiveNCT04694820
A Mobile Intervention (txt4TKI) for the Improvement of Tyrosine Kinase Inhibitor Management in Patients With Chronic Myeloid Leukemia
A study testing Text Message-Based Navigation Intervention and Survey Administration in people with Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Chronic Phase Chronic Myelogenous Leukemia, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This trial studies the feasibility and acceptability of a mobile intervention called txt4TKI for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia
- What is being tested?
- Text Message-Based Navigation Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 8 Apr 2022
- 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
- PHASE 1: Patients diagnosed with chronic myeloid leukemia
- PHASE 1: Initiated tyrosine kinase inhibitors therapy for a year
- PHASE 1: Able to read and understand English
- PHASE 1: Able to provide informed consent
- PHASE 1: Have a mobile phone with TXT capability
- PHASE 1: Know how to use TXT
Show all 13Show fewer
- PHASE 2: Patients diagnosed with chronic myeloid leukemia in the chronic phase
- PHASE 2: Starting tyrosine kinase inhibitors therapy or has been on tyrosine kinase inhibitors with anticipation of at least 6 month duration of use
- PHASE 2: Able to read and understand English
- PHASE 2: Able to provide informed consent
- PHASE 2: Have a mobile device with TXT capability
- PHASE 2: Willing to use a wireless pill bottle during study for 6 months
- PHASE 2: Know or willing to learn how to use TXT
Who cannot join
- Cognitive impaired document in the electronic medical record (EMR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients
This trial studies the feasibility and acceptability of a mobile intervention called txt4TKI for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia. Tyrosine kinase inhibitors (TKI) are associated with numerous potential side effects, including a decrease in bone marrow activity (myelosuppression), nausea, diarrhea, fatigue, and soft-tissue swelling (edema), especially in the face and lower legs, which are the primary reasons for patients to discontinue TKI medication. Using a mobile text messaging (TXT) intervention that emphasizes the importance of TKI compliance may improve TKI adherence in patients with chronic myeloid leukemia.
- Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia
- Being tested
- Text Message-Based Navigation Intervention, Survey Administration
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
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 txt4TKI
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Text message intervention | Experimental | Six month text message intervention Receives: Other: Text Message-Based Navigation Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of TKI Treatment Date
Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Measured: Up to 6 months post-baseline
Assessment of TKI Treatment change
Will be extracted from the electronic medical record (EMR) chart, including change of treatment.
Measured: Up to 6 months post-baseline
Assessment of TKI Discontinuation
Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
Measured: Up to 6 months post-baseline
Feasibility of Compliance
Will be measured through study accrual, attrition, adverse event monitoring data, and system usage frequencies. 90% of the study participants adequately use the smart pill bottles will be acceptable. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participant texting back to the system at least once will be considered adequate.
Measured: Up to 6 months post-baseline
Acceptability of Mobile Involvement
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score >= 3 on the 1-4 satisfaction scale. Further, transcripts of the audio recorded post-intervention patient interviews will be analyzed using grounded theory and constant comparative methods. Analysis will examine patient perceptions of the usefulness and satisfaction with the txt4TKI intervention. After the research team reaches a consensus on a coding scheme, the principal investigator (PI) and the project manager will code independently the transcripts, examining patient's satisfaction with and evaluation of the txt4TKI intervention.
Measured: Up to 6 months post-baseline
TKI adherence
Will be assessed by AdhereTech wireless smart pill bottes for all participants, 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.
Measured: Up to 6 months post-baseline
Symptom burden
The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.
Measured: Up to 6 months post-baseline
Knowledge and self-efficacy for taking medication
Will be measured by the Medication Understanding and Use Self-Efficacy (MUSE) Scale. It measures patients' self-efficacy in understanding and using medication.
Measured: Up to 6 months post-baseline
Barriers to adherence and problems with adherence behavior
Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).
Measured: Up to 6 months post-baseline
Beliefs in medications
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
Measured: Up to 6 months post-baseline
Individual illness perceptions
Will be assessed using Brief-Illness Perceptions Questionnaire (B-IPQ) that includes survey items assessing individual illness perceptions along the cognitive domains of the self-regulatory model as well as emotional responses to having CML.
Measured: Up to 6 months post-baseline
Self-efficacy for medication use
Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).
Measured: Up to 6 months post-baseline
Health-related quality of life (HRQoL)
Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of leukemia-specific sub scale.
Measured: Up to 6 months post-baseline
Health-related quality of life (HRQoL)
Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of a set of general HRQoL questions (Functional Assessment of Cancer Therapy-General [FACT-G])
Measured: Up to 6 months post-baseline
Self-efficacy for managing symptoms
Will be measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms.
Measured: Up to 6 months post-baseline
Affect
The Intrusion subscale of the Revised Impact of Events Scale (RIES) will be used to assess affective distress concerning TKI.
Measured: Up to 6 months post-baseline
Social Support
Will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS assesses perceptions of support received from family, friends, and significant others.
Measured: Up to 6 months post-baseline
Usefulness and satisfaction of txt4TKI
Patient interviews will explore key domains including perceived usefulness, how well txt4TKI address their concerns, whether there are additional issues they would like to see included and the characteristics of the text messaging (TXT). Client Satisfaction Questionnaire (CSQ-8) structured measures will ask participants to rate the usefulness and satisfaction of txt4TKI and how likely they would recommend the program to others.
Measured: Up to 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start5 Jun 2020
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia, BCR-ABL1 PositiveStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04694820
- Sponsor's protocol ID
- 20P.140
- Other IDs
- JT 14933
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- 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
- txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients
- ClinicalTrials.gov ID
- NCT04694820
- Acronym / sponsor ID
- 20P.140
- Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 5 Jan 2021 (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 trial studies the feasibility and acceptability of a mobile intervention called txt4TKI for the improvement of tyrosine kinase inhibitor management in patients with chronic myeloid leukemia. Tyrosine kinase inhibitors (TKI) are associated with numerous potential side effects, including a decrease in bone marrow activity (myelosuppression), nausea, diarrhea, fatigue, and soft-tissue swelling (edema), especially in the face and lower legs, which are the primary reasons for patients to discontinue TKI medication. Using a mobile text messaging (TXT) intervention that emphasizes the importance of TKI compliance may improve TKI adherence in patients with chronic myeloid leukemia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Text message intervention | Experimental | Other: Text Message-Based Navigation Intervention, Other: Survey AdministrationSix month text message intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- PHASE 1: Patients diagnosed with chronic myeloid leukemia
- PHASE 1: Initiated tyrosine kinase inhibitors therapy for a year
- PHASE 1: Able to read and understand English
- PHASE 1: Able to provide informed consent
- PHASE 1: Have a mobile phone with TXT capability
Key exclusion criteria (1 listed)
- Cognitive impaired document in the electronic medical record (EMR)
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 txt4TKI | Other | Text message intervention |
| Survey AdministrationAncillary studies | Other | Text message intervention |
Primary outcome
Assessment of TKI Treatment Date
Time frame: Up to 6 months post-baseline
Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Assessment of TKI Treatment change
Time frame: Up to 6 months post-baseline
Will be extracted from the electronic medical record (EMR) chart, including change of treatment.
Assessment of TKI Discontinuation
Time frame: Up to 6 months post-baseline
Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
Feasibility of Compliance
Time frame: Up to 6 months post-baseline
Will be measured through study accrual, attrition, adverse event monitoring data, and system usage frequencies. 90% of the study participants adequately use the smart pill bottles will be acceptable. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participant texting back to the system at least once will be considered adequate.
Acceptability of Mobile Involvement
Time frame: Up to 6 months post-baseline
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score >= 3 on the 1-4 satisfaction scale. Further, transcripts of the audio recorded post-intervention patient interviews will be analyzed using grounded theory and constant comparative methods. Analysis will examine patient perceptions of the usefulness and satisfaction with the txt4TKI intervention. After the research team reaches a consensus on a coding scheme, the principal investigator (PI) and the project manager will code independently the transcripts, examining patient's satisfaction with and evaluation of the txt4TKI intervention.
TKI adherence
Time frame: Up to 6 months post-baseline
Will be assessed by AdhereTech wireless smart pill bottes for all participants, 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.
Symptom burden
Time frame: Up to 6 months post-baseline
The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.
Knowledge and self-efficacy for taking medication
Time frame: Up to 6 months post-baseline
Will be measured by the Medication Understanding and Use Self-Efficacy (MUSE) Scale. It measures patients' self-efficacy in understanding and using medication.
Barriers to adherence and problems with adherence behavior
Time frame: Up to 6 months post-baseline
Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).
Beliefs in medications
Time frame: Up to 6 months post-baseline
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
Individual illness perceptions
Time frame: Up to 6 months post-baseline
Will be assessed using Brief-Illness Perceptions Questionnaire (B-IPQ) that includes survey items assessing individual illness perceptions along the cognitive domains of the self-regulatory model as well as emotional responses to having CML.
Self-efficacy for medication use
Time frame: Up to 6 months post-baseline
Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).
Health-related quality of life (HRQoL)
Time frame: Up to 6 months post-baseline
Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of leukemia-specific sub scale.
Health-related quality of life (HRQoL)
Time frame: Up to 6 months post-baseline
Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of a set of general HRQoL questions (Functional Assessment of Cancer Therapy-General [FACT-G])
Self-efficacy for managing symptoms
Time frame: Up to 6 months post-baseline
Will be measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms.
Affect
Time frame: Up to 6 months post-baseline
The Intrusion subscale of the Revised Impact of Events Scale (RIES) will be used to assess affective distress concerning TKI.
Social Support
Time frame: Up to 6 months post-baseline
Will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS assesses perceptions of support received from family, friends, and significant others.
Usefulness and satisfaction of txt4TKI
Time frame: Up to 6 months post-baseline
Patient interviews will explore key domains including perceived usefulness, how well txt4TKI address their concerns, whether there are additional issues they would like to see included and the characteristics of the text messaging (TXT). Client Satisfaction Questionnaire (CSQ-8) structured measures will ask participants to rate the usefulness and satisfaction of txt4TKI and how likely they would recommend the program to others.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
1 site 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 and Survey Administration in people with Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Chronic Phase Chronic Myelogenous Leukemia, run by Thomas Jefferson University at 1 site 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 13 inclusion and 1 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: finished, 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of TKI Treatment Date (time frame: Up to 6 months post-baseline). The study lists 18 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.