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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Receive txt4TKI
Ancillary studies
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Assessment of TKI Treatment Date
Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Time frame: 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.
Time frame: Up to 6 months post-baseline
Assessment of TKI Discontinuation
Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 6 months post-baseline
Beliefs in medications
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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 \[FACT-G\])
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months post-baseline
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