Patient Factors Impacting Adherence to Oral Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.

Official Title
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A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy

Conditions
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Breast Cancer, Gastrointestinal Cancer

Intervention / Treatment
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* Behavioral: questionnaire and interview


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast or gastrointestinal cancer pts taking capecitabine<br>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. | Behavioral: questionnaire and interview<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve the care of patients | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Chemotherapy, capecitabine, questionnaire, breast, gastric, 11-194