Patient Factors Impacting Adherence to Oral Chemotherapy
A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy
1 other identifier
observational
79
1 country
1
Brief Summary
The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 8, 2016
November 1, 2016
5 years
November 30, 2011
November 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adherence to oral chemotherapy
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 Outcomes (1)
improve the care of patients
1 year
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
MSKCC clinics
You may qualify if:
- Diagnosis of primary breast cancer or gastrointestinal cancer
- Currently prescribed capecitabine
- Age 21 years or older
- Able to understand written and oral English
You may not qualify if:
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Ginex, EdD, RN, OCN
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 7, 2011
Study Start
November 1, 2011
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
November 8, 2016
Record last verified: 2016-11