The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.
Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)
Study Type
OBSERVATIONAL
Enrollment
1,494
The rate of Complete Cytogenetic Response
Time frame: 12 months
The duration of initial TKI treatment
Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
Time frame: 5-years from study index date
The rate of discontinuation and treatment changes after initial TKI treatment
Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)
Time frame: Every 6 months for a follow-up period of 5-years from study index date
The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)
Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
Time frame: Every 6 months for a follow-up period of 5-years from study index date
The adherence to treatment
Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
Time frame: Every 6 months for a follow-up period of 5-years from study index date
Impact of first-line treatment options on quality of life
Questionnaires used for assessment: Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).
Time frame: Every 6 months
Non-hematologic side effects from treatment affecting patient quality of life and outcomes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Little Rock Hematology Oncology Associates
Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Inc
Anaheim, California, United States
Southwest Cancer Care Medical Group
Escondido, California, United States
Wilshire Oncology Medical Group, Inc
Glendora, California, United States
...and 204 more locations
Treatment discontinuations and changes
Time frame: Every 6 months
Patient satisfaction with CML treatment
Cancer Therapy Satisfaction Questionnaire (CTSQ)
Time frame: Every 6 months
Patterns of disease monitoring as observed in a real-world setting
MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function
Time frame: Every 6 months
Resource utilization associated with CML management
To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.
Time frame: Every 6 months