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

NCT04694820 | Completed

• 2 other identifiers: 20P.140JT 14933
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (1)

Text message intervention

EXPERIMENTAL

Six month text message intervention

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

Interventions

Text Message-Based Navigation Intervention OTHER

Receive txt4TKI

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Text message intervention

Survey Administration OTHER

Ancillary studies

Text message intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impaired document in the electronic medical record (EMR)

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: January 5, 2021
• Study Start: June 5, 2020
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)