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

Thomas Jefferson University

Status: Completed

Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia

Treatments: Other: Survey Administration; Other: Text Message-Based Navigation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04694820

20P.140

JT 14933 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Text message intervention

Experimental group

Description:

Six month text message intervention

Treatment:

Other: Text Message-Based Navigation Intervention

Other: Survey Administration