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CompletedNCT01487343Updated Nov 8, 2016

Patient Factors Impacting Adherence to Oral Chemotherapy

An observational study in Breast Cancer and Gastrointestinal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-11-08.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
79
Ages
21 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Breast Cancer
  • Gastrointestinal Cancer

Keywords

  • Oral Chemotherapy
  • capecitabine
  • questionnaire
  • breast
  • gastric
  • 11-194
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In context

Gastrointestinal Neoplasms

779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.

This study's enrollment of 79 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

MSKCC clinics

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
79 participants (actual)

Groups and cohorts

  • 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.

    Behavioral: questionnaire and interview

Interventions

  • Behavioralquestionnaire 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.

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What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

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Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01487343
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Dec 7, 2011
Start date
Nov 2011
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Nov 8, 2016

Study contacts

Pamela Ginex, EdD, RN, OCN
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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