Preparatory Work to Assess Adherence to Oral Chemotherapy

Completed

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT02895542
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Study Start: 2016-12-20
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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Exclusion Criteria

• Patient does not speak English or requires an interpreter for medical visits
• Patient is cognitively impaired, as determined by the referring provider

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Demographic and Health Behaviors Questionnaire	Study 1 day Visit	Questions will be asked about the participants demographic background and health behaviors.
Brief Medication Questionnaire (BMQ)	Study 1 day Visit	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.
Single Item Adherence Measure 1	Study 1 day Visit	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.
Single Item Adherence Measure 2	Study 1 day Visit	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.

Secondary Outcome Measures

Name	Time	Method
REALM-SF	Study 1 day Visit	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.
Medications Adherence Reasons Scale (MARS)	Study 1 day Visit	This questionnaire is designed to identify potential risk factors associated with medication-related non-adherence.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States