A Mobile Intervention (txt4TKI) for the Improvement of Tyrosine Kinase Inhibitor Management in Patients With Chronic Myeloid Leukemia
- Conditions
- Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous Leukemia
- Interventions
- Other: Text Message-Based Navigation InterventionOther: Survey Administration
- Registration Number
- NCT04694820
- Lead Sponsor
- Thomas Jefferson University
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
• Cognitive impaired document in the electronic medical record (EMR)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Text message intervention Survey Administration Six month text message intervention Text message intervention Text Message-Based Navigation Intervention Six month text message intervention
- Primary Outcome Measures
Name Time Method Assessment of TKI Treatment change Up to 6 months post-baseline Will be extracted from the electronic medical record (EMR) chart, including change of treatment.
Symptom burden Up to 6 months post-baseline The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.
Assessment of TKI Discontinuation Up to 6 months post-baseline Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
Barriers to adherence and problems with adherence behavior Up to 6 months post-baseline Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).
Assessment of TKI Treatment Date Up to 6 months post-baseline Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Self-efficacy for managing symptoms 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 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.
Feasibility of Compliance 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 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.
Knowledge and self-efficacy for taking medication 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.
Health-related quality of life (HRQoL) 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 \[FACT-G\])
Social Support 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.
TKI adherence 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.
Beliefs in medications Up to 6 months post-baseline Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
Self-efficacy for medication use Up to 6 months post-baseline Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).
Usefulness and satisfaction of txt4TKI 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.
Individual illness perceptions 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States