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

Primary outcomes

1. 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

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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).

10. Beliefs in medications

    Time frame: Up to 6 months post-baseline

    Will be measured using the Beliefs in Medicines Questionnaire (BMQ).

11. 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.

12. 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).

13. 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.

14. 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])

15. 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.

16. 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.

17. 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.

18. 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.