Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w/Chronic Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)
Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib
A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or
Disqualifiers
Unable to read and speak English
Impaired decisional capacity to consent
Trial population
The study populations include adult patients with CML in chronic phase (CML-CP) who are being treated with one of the four TKIs - imatinib, dasatinib, bosutinib, and nilotinib
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Interview
Other interventionIn-person interview with the study coordinator to complete study questionnaire.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Adult patients with CML in chronic phase (CML-CP)1 intervention
Trial outcomes
Primary outcomes
1
Assessment of adherence to TKI medication
This will be measured by Morisky Medication Adherence Scale (MMAS), an 8-item tool related to adherence behavior include forgetfulness, stopping medication because of worsening of symptoms or improvement in health condition, and inconvenience of continuing medication. Each item is scored 0 or 1 depending on whether the patient answers yes or no, with a minimum score of 0 and maximum score of 8
Time frame
Up to 1 year2
Personality assessment
Patient personality will be assessed using the Mini International Personality Item Pool (mini-IPIP) questionnaire. In the mini-IPIP, each of the five factors (openness, conscientiousness, extraversion, agreeableness and neuroticism) is assessed with four items, making a total of 20 items. Each item is scored on a scale of 1 through 5, with 1 indicating "very inaccurate" and 5 corresponding to "very accurate"
Time frame
Up to 1 year3
Assessment of quality of Life
This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30). EORTC QLQ C30 includes 30 items that measure global health status, functioning, and symptoms.
Time frame
Up to 1 year4
Assessment of quality of Life and symptom burden
This will be measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Chronic Myeloid Leukemia -24 scales.(EROTC QLQ-CML 24). The EORTC QLQ CML 24 is a 24-item questionnaire developed exclusively to assess QoL issues in patients with CML
Time frame
Up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov