Clinical trial NCT04694820: A Mobile Intervention (txt4TKI) for the Improvement of Tyrosine Kinase Inhibitor Management in Patients With Chronic Myeloid Leukemia
Official title: txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Phase Chronic Myelogenous Leukemia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of TKI Treatment Date
timeFrame: Up to 6 months post-baseline
measure: Assessment of TKI Treatment change
timeFrame: Up to 6 months post-baseline
measure: Assessment of TKI Discontinuation
timeFrame: Up to 6 months post-baseline
measure: Feasibility of Compliance
timeFrame: Up to 6 months post-baseline
measure: Acceptability of Mobile Involvement
timeFrame: Up to 6 months post-baseline
measure: TKI adherence
timeFrame: Up to 6 months post-baseline
measure: Symptom burden
timeFrame: Up to 6 months post-baseline
measure: Knowledge and self-efficacy for taking medication
timeFrame: Up to 6 months post-baseline
measure: Barriers to adherence and problems with adherence behavior
timeFrame: Up to 6 months post-baseline
measure: Beliefs in medications
timeFrame: Up to 6 months post-baseline
measure: Individual illness perceptions
timeFrame: Up to 6 months post-baseline
measure: Self-efficacy for medication use
timeFrame: Up to 6 months post-baseline
measure: Health-related quality of life (HRQoL)
timeFrame: Up to 6 months post-baseline
measure: Health-related quality of life (HRQoL)
timeFrame: Up to 6 months post-baseline
measure: Self-efficacy for managing symptoms
timeFrame: Up to 6 months post-baseline
measure: Affect
timeFrame: Up to 6 months post-baseline
measure: Social Support
timeFrame: Up to 6 months post-baseline
measure: Usefulness and satisfaction of txt4TKI
timeFrame: Up to 6 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: