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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message-Based Navigation Intervention
Survey Administration
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Text message intervention

Arm Description

Six month text message intervention

Outcomes

Primary Outcome Measures

Assessment of TKI Treatment Date
Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Assessment of TKI Treatment change
Will be extracted from the electronic medical record (EMR) chart, including change of treatment.
Assessment of TKI Discontinuation
Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
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.
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.
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.
Symptom burden
The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.
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.
Barriers to adherence and problems with adherence behavior
Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).
Beliefs in medications
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
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.
Self-efficacy for medication use
Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).
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.
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])
Self-efficacy for managing symptoms
Will be measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms.
Affect
The Intrusion subscale of the Revised Impact of Events Scale (RIES) will be used to assess affective distress concerning TKI.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
August 4, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04694820
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
April 8, 2022 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text message intervention
Arm Type
Experimental
Arm Description
Six month text message intervention
Intervention Type
Other
Intervention Name(s)
Text Message-Based Navigation Intervention
Other Intervention Name(s)
Automated Text Message-Based Navigation, Text Message-Based Navigation
Intervention Description
Receive txt4TKI
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Assessment of TKI Treatment Date
Description
Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates
Time Frame
Up to 6 months post-baseline
Title
Assessment of TKI Treatment change
Description
Will be extracted from the electronic medical record (EMR) chart, including change of treatment.
Time Frame
Up to 6 months post-baseline
Title
Assessment of TKI Discontinuation
Description
Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment
Time Frame
Up to 6 months post-baseline
Title
Feasibility of Compliance
Description
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.
Time Frame
Up to 6 months post-baseline
Title
Acceptability of Mobile Involvement
Description
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.
Time Frame
Up to 6 months post-baseline
Title
TKI adherence
Description
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.
Time Frame
Up to 6 months post-baseline
Title
Symptom burden
Description
The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.
Time Frame
Up to 6 months post-baseline
Title
Knowledge and self-efficacy for taking medication
Description
Will be measured by the Medication Understanding and Use Self-Efficacy (MUSE) Scale. It measures patients' self-efficacy in understanding and using medication.
Time Frame
Up to 6 months post-baseline
Title
Barriers to adherence and problems with adherence behavior
Description
Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).
Time Frame
Up to 6 months post-baseline
Title
Beliefs in medications
Description
Will be measured using the Beliefs in Medicines Questionnaire (BMQ).
Time Frame
Up to 6 months post-baseline
Title
Individual illness perceptions
Description
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.
Time Frame
Up to 6 months post-baseline
Title
Self-efficacy for medication use
Description
Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).
Time Frame
Up to 6 months post-baseline
Title
Health-related quality of life (HRQoL)
Description
Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of leukemia-specific sub scale.
Time Frame
Up to 6 months post-baseline
Title
Health-related quality of life (HRQoL)
Description
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])
Time Frame
Up to 6 months post-baseline
Title
Self-efficacy for managing symptoms
Description
Will be measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms.
Time Frame
Up to 6 months post-baseline
Title
Affect
Description
The Intrusion subscale of the Revised Impact of Events Scale (RIES) will be used to assess affective distress concerning TKI.
Time Frame
Up to 6 months post-baseline
Title
Social Support
Description
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.
Time Frame
Up to 6 months post-baseline
Title
Usefulness and satisfaction of txt4TKI
Description
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.
Time Frame
Up to 6 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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