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

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ClinicalTrials.gov Identifier: NCT04694820
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase Chronic Myelogenous Leukemia Other: Text Message-Based Navigation Intervention Other: Survey Administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: txt4TKI: An Innovative Mobile Intervention to Improve Tyrosine Kinase Inhibitor Management Among Chronic Myeloid Leukemia Patients
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 31, 2021



Intervention Details:
  • Other: Text Message-Based Navigation Intervention
    Receive txt4TKI
    Other Name: Automated Text Message-Based Navigation, Text Message-Based Navigation
  • Other: Survey Administration
    Ancillary studies


Primary Outcome Measures :
  1. Assessment of TKI Treatment Date [ Time Frame: Up to 6 months post-baseline ]
    Will be extracted from the electronic medical record (EMR) chart, including tyrosine kinase inhibitor (TKI) treatment initiation dates

  2. Assessment of TKI Treatment change [ Time Frame: Up to 6 months post-baseline ]
    Will be extracted from the electronic medical record (EMR) chart, including change of treatment.

  3. Assessment of TKI Discontinuation [ Time Frame: Up to 6 months post-baseline ]
    Will be extracted from the electronic medical record (EMR) chart, including discontinuing treatment

  4. Feasibility of Compliance [ Time Frame: Up to 6 months post-baseline ]
    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.

  5. Acceptability of Mobile Involvement [ Time Frame: Up to 6 months post-baseline ]
    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.

  6. TKI adherence [ Time Frame: Up to 6 months post-baseline ]
    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.

  7. Symptom burden [ Time Frame: Up to 6 months post-baseline ]
    The MD Anderson Symptom Inventory-Chronic Myeloid Leukemia (MDASI-CML) will be used to assess patient symptom burden.

  8. Knowledge and self-efficacy for taking medication [ Time Frame: Up to 6 months post-baseline ]
    Will be measured by the Medication Understanding and Use Self-Efficacy (MUSE) Scale. It measures patients' self-efficacy in understanding and using medication.

  9. Barriers to adherence and problems with adherence behavior [ Time Frame: Up to 6 months post-baseline ]
    Will be assessed by the Adherence Starts With Knowledge 12 Questionnaire (ASK-12).

  10. Beliefs in medications [ Time Frame: Up to 6 months post-baseline ]
    Will be measured using the Beliefs in Medicines Questionnaire (BMQ).

  11. Individual illness perceptions [ Time Frame: Up to 6 months post-baseline ]
    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.

  12. Self-efficacy for medication use [ Time Frame: Up to 6 months post-baseline ]
    Will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS).

  13. Health-related quality of life (HRQoL) [ Time Frame: Up to 6 months post-baseline ]
    Will be assessed using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Questionnaire consisting of leukemia-specific sub scale.

  14. Health-related quality of life (HRQoL) [ Time Frame: Up to 6 months post-baseline ]
    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])

  15. Self-efficacy for managing symptoms [ Time Frame: Up to 6 months post-baseline ]
    Will be measured by a modified version of Lorig's Chronic Disease Self-Efficacy Scale for managing symptoms.

  16. Affect [ Time Frame: Up to 6 months post-baseline ]
    The Intrusion subscale of the Revised Impact of Events Scale (RIES) will be used to assess affective distress concerning TKI.

  17. Social Support [ Time Frame: Up to 6 months post-baseline ]
    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.

  18. Usefulness and satisfaction of txt4TKI [ Time Frame: Up to 6 months post-baseline ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694820


Contacts
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Contact: Kuang-Yi Wen, MD 215-503-4623 Kuang-Yi.Wen@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kuang-Yi Wen, MD    215-503-4623    Kuang-Yi.Wen@Jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04694820    
Other Study ID Numbers: 20D.140
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases