- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00712569
Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Commack, New York, United States
- Memorial Sloan-Kettering Cancer Center at Commack
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Sleepy Hollow, New York, United States
- Memoral Sloan Kettering Cancer Center@Phelps
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Subject Inclusion Criteria for Patients
- Female
- Diagnosis of breast cancer
- Pre-surgery (*for breast surgeon patients only)
- Report that they have read breast cancer-related internet information since their diagnosis with breast cancer.
- Provide informed consent
Subject Inclusion Criteria Physicians
- Breast surgeon or breast medical oncologist
- Agree to participate in study and one of 10 selected participants
- Provide inform consent
Exclusion Criteria:
Exclusion Criteria for Patients
- Less than 21 years of age
- Cognitive or physical impairment rendering patients incapable of providing informed consent to participate in the study
- As the measures and coding system are all written in English, subjects who are not fluent in English will be excluded.
Exclusion Criteria for Physicians
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients in Category 1 are those who report before the visit that they intend to discuss cancer-related internet information and report after the visit that they did discuss such information.
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Patients in Category 1 are those who report before the visit that they intend to discuss cancer-related internet information and report after the visit that they did discuss such information.
The coding of these patients' consultations with their physicians and analysis of their pre- and post-consultation questionnaires will address Aims 1 and 2.
|
2
Patients in Category 2 are those who report before the visit that they intend to discuss cancer-related internet information, but report after the visit that they did not discuss such information.
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Patients in Category 2 are those who report before the visit that they intend to discuss cancer-related internet information, but report after the visit that they did not discuss such information. This category is important as our previous research indicates that sometimes patients do not discuss information because they feel there is not enough time or because the information is irrelevant or repetitive. These patients' audio recordings will be checked to verify that there was no internet information discussion. These audio recordings will not be coded. However, assessment of these patients' questionnaires will aid in addressing Aim 3 and may provide some pilot data on why patients who initially intend to discuss internet information do not. |
3
Patients in Category 3 are those who report before the visit that they do not intend to discuss cancer-related internet information and do not discuss it.
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Patients in Category 3 are those who report before the visit that they do not intend to discuss cancer-related internet information and do not discuss it.
Assessment of these patients' questionnaires will aid in addressing Aim 3.
These audio recordings will not be coded.
It is important, however, that these consultations be audio recorded for two reasons: First, it allows the physician to remain blinded to the intent of the patient to discuss internet information.
Second, it provides a method of verifying that the patient really did not discuss internet information.
Although not expected, it is possible for a patient to go into a consultation without intending to discuss internet information, but does end up discussing it.
We will note if this occurs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
patients in Category 1 (those who have been recorded discussing internet information with their physician) are pt satisfaction & pt anxiety. PT satisfaction with the consultation is an outcome assessed only at the end of the consultation.
Time Frame: conclusion of the study
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conclusion of the study
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To examine the effect of physician responses to cancer-related internet information on patient satisfaction and anxiety. (Category 1 patients).
Time Frame: conclusion of study
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conclusion of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients).
Time Frame: conclusion of study
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conclusion of study
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-079
- NIH (NIH U19 AI 90023)
- NCI (HHSN261200700046C)
- R03CA130591-01 (U.S. NIH Grant/Contract)
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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