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Clinical Trials/NCT02895542
NCT02895542
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country86 target enrollmentDecember 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Myeloid Leukemia
Sponsor
Wake Forest University Health Sciences
Enrollment
86
Locations
1
Primary Endpoint
Patient Demographic and Health Behaviors Questionnaire
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2016
End Date
April 28, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient Demographic and Health Behaviors Questionnaire

Time Frame: Study 1 day Visit

Questions will be asked about the participants demographic background and health behaviors.

Brief Medication Questionnaire (BMQ)

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • REALM-SF(Study 1 day Visit)
  • Medications Adherence Reasons Scale (MARS)(Study 1 day Visit)

Study Sites (1)

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