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

Chronic Phase Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694820
• Other study ID #: 20P.140
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: April 8, 2022

Study information

• Verified date: August 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Phase Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Other:
• Text Message-Based Navigation Intervention
Receive txt4TKI
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Assessment of TKI Discontinuation	Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment	Up to 6 months post-baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Beliefs in medications	Will be measured using the Beliefs in Medicines Questionnaire (BMQ).	Up to 6 months post-baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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