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Patient Factors Impacting Adherence to Oral Chemotherapy

NCT ID: NCT01487343

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-11-30

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.

Detailed Description

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Conditions

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Breast Cancer Gastrointestinal Cancer

Keywords

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Oral Chemotherapy capecitabine questionnaire breast gastric 11-194

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

questionnaire and interview

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Ginex, EdD, RN, OCN

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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11-194

Identifier Type: -

Identifier Source: org_study_id