Breast CancerNCT00712569
Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaires, audio recordings , questionnaires and audio recorded questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Feb 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: physicians at the Breast Service and their patients will be recruited to participate in this study.
Who may be able to join
- 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
Show all 10Show fewer
- Subject Inclusion Criteria Physicians
- Breast surgeon or breast medical oncologist
- Agree to participate in study and one of 10 selected participants
- Provide inform consent
Who cannot join
- 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.
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- questionnaires, audio recordings , questionnaires, audio recorded questionnaires
- Keywords
- Communication, Internet, Physician, Patient, 08-079
- Medical subject headings
- Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
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 , questionnairesBehavioural
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 questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: questionnaires | |
| 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. Receives: Behavioral: audio recordings , questionnaires | |
| 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. Receives: Behavioral: audio recorded questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: conclusion of the study
To examine the effect of physician responses to cancer-related internet information on patient satisfaction and anxiety. (Category 1 patients).
Measured: conclusion of study
Secondary outcomes (1)
To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients).
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2015
- Study completionFeb 2015
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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Smita Banerjee, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712569
- Sponsor's protocol ID
- 08-079
- Other IDs
- NIH, NCI, R03CA130591-01
- Status last verified
- Feb 2015
- First submitted
- 7 Jul 2008
- Last updated
- 6 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
- ClinicalTrials.gov ID
- NCT00712569
- Acronym / sponsor ID
- 08-079
- Conditions
- Breast Cancer
- Keywords
- Communication, Internet, Physician, Patient, 08-079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Jul 2008 (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 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnairesPatients 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. |
| 2 | – | Behavioral: audio recordings , questionnairesPatients 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. |
| 3 | – | Behavioral: audio recorded questionnairesPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- physicians at the Breast Service and their patients will be recruited to participate in this study.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- None
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 |
|---|---|---|
| questionnairesPatients 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. | Behavioural | 1 |
| audio recordings , questionnairesPatients 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. | Behavioural | 2 |
| audio recorded questionnairesPatients 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. | Behavioural | 3 |
Primary outcome
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
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
1 secondary outcome
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
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 6 Feb 2015.
- 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.
Smita Banerjee, PhD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites 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, run by Memorial Sloan Kettering Cancer Center at 3 sites 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 10 inclusion and 4 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 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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). The study lists 2 primary outcomes in all. 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 6 Feb 2015.