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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00712569
Other study ID # 08-079
Secondary ID NIHNCIR03CA13059
Status Completed
Phase N/A
First received July 7, 2008
Last updated February 5, 2015
Start date June 2008
Est. completion date February 2015

Study information

Verified date February 2015
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn about how patients who have looked up cancer-related information on the internet talk with their doctors. We are interested in these conversations even if the patients do not think they will talk about the information with their doctor during their visit. We will audio record doctor-patient visits and listen to these recordings to learn about how patients who have looked up cancer-related internet information talk to their doctors and how their doctors talk to them. We will also give patients questionnaires before and after their appointments to learn about what they think about communicating with their doctors.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
questionnaires
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.
audio recordings , questionnaires
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.
audio recorded questionnaires
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.

Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center at Commack Commack New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Memoral Sloan Kettering Cancer Center@Phelps Sleepy Hollow New York

Sponsors (3)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. conclusion of the study No
Primary To examine the effect of physician responses to cancer-related internet information on patient satisfaction and anxiety. (Category 1 patients). conclusion of study No
Secondary To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients). conclusion of study No
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