txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment of TKI Discontinuation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Text message intervention
Six month text message intervention
Intervention: Survey Administration (Other)
Text message intervention
Six month text message intervention
Intervention: Text Message-Based Navigation Intervention (Other)
Outcomes
Primary Outcomes
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
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.
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.
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.
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).
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
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.
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.
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.
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.
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.
Beliefs in medications
Time Frame: Up to 6 months post-baseline
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
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).
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.
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.
Secondary Outcomes
No secondary outcomes reported