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

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

    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

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.
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.
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.

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

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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