Patient Factors Impacting Adherence to Oral Chemotherapy
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01487343
First received: November 30, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.
| Condition | Intervention |
|---|---|
|
Breast Cancer Gastrointestinal Cancer |
Behavioral: questionnaire and interview |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- adherence to oral chemotherapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- improve the care of patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
MSKCC clinics
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487343
Contacts
| Contact: Pamela Ginex, EdD, RN, OCN | 646-449-1077 | |
| Contact: Bridgette Thom, MS | 646-449-1075 |
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Pamela Ginex, EdD, RN, OCN 646-449-1077 | |
| Contact: Bridgette Thom, MS 646-449-1075 | |
| Principal Investigator: Pamela Ginex, EdD, RN, OCN | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Pamela Ginex, EdD, RN, OCN | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01487343 History of Changes |
| Other Study ID Numbers: | 11-194 |
| Study First Received: | November 30, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Oral Chemotherapy capecitabine questionnaire |
breast gastric 11-194 |
Additional relevant MeSH terms:
|
Breast Neoplasms Gastrointestinal Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013