Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Institutes of Health (NIH) National Cancer Institute (NCI)
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00712569

Purpose

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.

Condition	Intervention
Breast Cancer	Behavioral: questionnaires Behavioral: audio recordings , questionnaires Behavioral: audio recorded questionnaires

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anxiety Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Crossover, Prospective
Official Title:	Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	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.
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.	Behavioral: 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.
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.	Behavioral: 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

10 physicians at the Breast Service and their patients will be recruited to participate in this study.

Criteria

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 during the past month.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712569

Contacts

Contact: Carma Bylund-Lincoln, PhD		bylundlc@mskcc.org
Contact: Alexandra Heerdt, MD		heerdta@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Carma Bylund-Lincoln, PhD bylundlc@mskcc.org
Principal Investigator: Carma Bylund-Lincoln, PhD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Carma Bylund-Lincoln, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Carma Bylund-Lincoln, PhD )
Study ID Numbers:	08-079, NIH, NCI
Study First Received:	July 7, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00712569
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Communication
Internet
Physician
Patient

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009