Patient Factors Impacting Adherence to Oral Chemotherapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487343
• Other study ID #: 11-194
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: November 7, 2016
• Start date: November 2011
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• questionnaire and interview
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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center