A Mobile Intervention (txt4TKI) for the Improvement of Tyrosine Kinase Inhibitor Management in Patients With Chronic Myeloid Leukemia

Study Overview
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Brief Summary
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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.

Official Title
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txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients

Conditions
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Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia

Intervention / Treatment
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* Other: Text Message-Based Navigation Intervention
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: • Cognitive impaired document in the electronic medical record (EMR)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text message intervention<br>Six month text message intervention | Other: Text Message-Based Navigation Intervention<br>* Receive txt4TKI<br>* Other names: Automated Text Message-Based Navigation, Text Message-Based Navigation;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of TKI Treatment Date | Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates | 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. | Up to 6 months post-baseline | 
| Assessment of TKI Discontinuation | Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment | 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. | 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. | 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. | 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. | 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. | 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). | Up to 6 months post-baseline | 
| Beliefs in medications | Will be measured using the Beliefs in Medicines Questionnaire (BMQ). | 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. | 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). | 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. | 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]) | 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. | 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. | 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. | 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. | Up to 6 months post-baseline |