Preparatory Work to Assess Adherence to Oral Chemotherapy

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895542
• Other study ID #: IRB00039112
• Secondary ID: REBAWF 99716CD
• Status: Completed
• Start date: December 20, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Demographic and Health Behaviors Questionnaire	Questions will be asked about the participants demographic background and health behaviors.	Study 1 day Visit
Primary	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
Primary	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
Primary	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	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
Secondary	Medications Adherence Reasons Scale (MARS)	This questionnaire is designed to identify potential risk factors associated with medication-related non-adherence.	Study 1 day Visit