Breast CancerNCT01487343
Patient Factors Impacting Adherence to Oral Chemotherapy
An observational study of Breast Cancer and Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Gastrointestinal Cancer
- What is being tested?
- questionnaire and interview
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- Diagnosis of primary breast cancer or gastrointestinal cancer
- Currently prescribed capecitabine
- Age 21 years or older
- Able to understand written and oral English
Who cannot join
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Breast Cancer, Gastrointestinal Cancer
- Being tested
- questionnaire and interview
- Keywords
- Oral Chemotherapy, capecitabine, questionnaire, breast, gastric, 11-194
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire and interviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: questionnaire and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Ginex, EdD, RN, OCN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487343
- Sponsor's protocol ID
- 11-194
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2011
- Last updated
- 8 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT01487343
- Acronym / sponsor ID
- 11-194
- Conditions
- Breast Cancer, Gastrointestinal Cancer
- Keywords
- Oral Chemotherapy, capecitabine, questionnaire, breast, gastric, 11-194
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast or gastrointestinal cancer pts taking capecitabine | – | Behavioral: questionnaire and interviewThis 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (4 listed)
- Diagnosis of primary breast cancer or gastrointestinal cancer
- Currently prescribed capecitabine
- Age 21 years or older
- Able to understand written and oral English
Key exclusion criteria (1 listed)
- Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire and interviewInterviews 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. | Behavioural | breast or gastrointestinal cancer pts taking capecitabine |
Primary outcome
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 secondary outcome
improve the care of patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Ginex, EdD, RN, OCN principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Gastrointestinal Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to oral chemotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.