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

txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients

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 Overview

• Status: Completed
• Conditions: Chronic Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Intervention / Treatment: Other: Survey Administration; Other: Text Message-Based Navigation Intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text message intervention; Six month text message intervention	Other: Survey Administration; Ancillary studies; Other: Text Message-Based Navigation Intervention; Receive txt4TKI; Other Names: Automated Text Message-Based Navigation, Text Message-Based Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of TKI Treatment Date	Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates	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.	Up to 6 months post-baseline
Assessment of TKI Discontinuation	Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment	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.	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.	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.	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.	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.	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).	Up to 6 months post-baseline
Beliefs in medications	Will be measured using the Beliefs in Medicines Questionnaire (BMQ).	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.	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).	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.	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])	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.	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.	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.	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.	Up to 6 months post-baseline

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chronic Disease; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: 20P.140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No