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Preparatory Work to Assess Adherence to Oral Chemotherapy

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ClinicalTrials.gov Identifier: NCT02895542
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
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.

Condition or disease
Chronic Myeloid Leukemia

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.

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Study Type : Observational
Actual Enrollment : 86 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Preparatory Work to Assess Adherence to Oral Chemotherapy Among Patients With Chronic Myeloid Leukemia
Actual Study Start Date : December 20, 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Oral Anti-Cancer Agent
No intervention

Primary Outcome Measures :
  1. Patient Demographic and Health Behaviors Questionnaire [ Time Frame: Study 1 day Visit ]
    Questions will be asked about the participants demographic background and health behaviors.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. REALM-SF [ Time Frame: 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.

  2. Medications Adherence Reasons Scale (MARS) [ Time Frame: Study 1 day Visit ]
    This questionnaire is designed to identify potential risk factors associated with medication-related non-adherence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Conducting brief structured interviews, to further understand potential patient characteristics and barriers associated with non-adherence of medication. With this knowledge of identified patient barriers, interventional strategies can be designed to improve CML care, monitoring and adherence.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895542

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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Kathryn Weaver, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02895542    
Other Study ID Numbers: IRB00039112
REBAWF 99716CD ( Other Identifier: NCI )
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases