Preparatory Work to Assess Adherence to Oral Chemotherapy

Study Overview
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Brief Summary
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This study to find out more about how patients take their anticancer medications and challenges related to taking cancer medications.

Detailed Description
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120 patients with Chronic Myeloid Leukemia (CML) who are currently prescribed an oral anti-cancer agent from up to 6 CCDR NCORP sites to complete a brief interviewer administered survey to assess medication adherence and related factors.

Official Title
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Preparatory Work to Assess Adherence to Oral Chemotherapy Among Patients With Chronic Myeloid Leukemia

Conditions
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Chronic Myeloid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is diagnosed with Chronic Myeloid Leukemia (CML) and is receiving care for CML at a participating CCDR NCORP practice, Patient had been prescribed one of the following oral anticancer agents for CML for ≥30 days (Imatinib, Nilotinib, Dasatinib, Bosutinib, Ponatinib). Prior use of any of these medications is allowed, as long as they have been on a stable regimen for at least 30 days prior to enrollment. Patient is 18 years of age or older Exclusion Criteria: Patient does not speak English or requires an interpreter for medical visits Patient is cognitively impaired, as determined by the referring provider

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Anti-Cancer Agent<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Demographic and Health Behaviors Questionnaire | Questions will be asked about the participants demographic background and health behaviors. | Study 1 day Visit | 
| Brief Medication Questionnaire (BMQ) | A self-report tool for screening adherence and barriers to adherence. The tool includes a 5-item Regimen Screen that asks patients how they took each medication in the past week, a 2-item Belief Screen that asks about drug effects and bothersome features, and a 2-item Recall Screen about potential difficulties remembering. | Study 1 day Visit | 
| Single Item Adherence Measure 1 | This is a single question. This measure was developed to serve as simple means of identifying sub-optimal adherence which could help identify at-risk patients for interventions. | Study 1 day Visit | 
| Single Item Adherence Measure 2 | This single item was developed to evaluate self-report adherence to medication and has demonstrated low patient burden and the ability to predict adherence-related clinical outcomes as good or better than other adherence measures. | Study 1 day Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REALM-SF | The REALM-SF offers researchers a simplified, validated, and efficient instrument for assessing patient literacy in clinical setting. It can be used to investigate the relationship between literacy and specific health outcomes such as medication adherence and health care utilization. | Study 1 day Visit | 
| Medications Adherence Reasons Scale (MARS) | This questionnaire is designed to identify potential risk factors associated with medication-related non-adherence. | Study 1 day Visit |