Skip to main content
OpenTrials
Completed

NCT Number: NCT02895542

Preparatory Work to Assess Adherence to Oral Chemotherapy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.