- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487343
Patient Factors Impacting Adherence to Oral Chemotherapy
November 7, 2016 updated by: Memorial Sloan Kettering Cancer Center
A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy
The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
79
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MSKCC clinics
Description
Inclusion Criteria:
- Diagnosis of primary breast cancer or gastrointestinal cancer
- Currently prescribed capecitabine
- Age 21 years or older
- Able to understand written and oral English
Exclusion Criteria:
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
breast or gastrointestinal cancer pts taking capecitabine
This is a mixed-methodology pilot study of patients currently taking oral chemotherapy for breast or gastrointestinal cancer.
The quantitative portion of the study consists of self-report questionnaires assessing adherence, beliefs about medications, side effect experience, self-efficacy, and satisfaction with patient education; the qualitative portion is an interview guided by two open-ended questions.
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Interviews will be conducted with the first 10 participants who agree to be interviewed (or until data saturation is reached).
Self-report questionnaires assessing adherence, beliefs about medications, side effect experience, self-efficacy, and satisfaction with patient education; the qualitative portion is an interview guided by two open-ended questions.
Data will be collected approximately 2 weeks - 6 months (2 - 24 weeks) after being prescribed capecitabine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence to oral chemotherapy
Time Frame: 1 year
|
Participation in the study entails completion of five short questionnaires related to the medication adherence (Medication Adherence Questionnaire), beliefs about medication (Beliefs about Medications Questionnaire), side effect experience (Frequency, Intensity, and Burden of Side Effects Rating), self-efficacy (Self-efficacy for Appropriate Medication Use) and satisfaction with medication information (Satisfaction with Information about Medicines Scale) as well as a demographic and treatment data sheet.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improve the care of patients
Time Frame: 1 year
|
Participation in the study entails completion of five short questionnaires related to the medication adherence (Medication Adherence Questionnaire), beliefs about medication (Beliefs about Medications Questionnaire), side effect experience (Frequency, Intensity, and Burden of Side Effects Rating), self-efficacy (Self-efficacy for Appropriate Medication Use) and satisfaction with medication information (Satisfaction with Information about Medicines Scale) as well as a demographic and treatment data sheet.
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
November 30, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (ESTIMATE)
December 7, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 8, 2016
Last Update Submitted That Met QC Criteria
November 7, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-194
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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