- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00712569
Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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Commack, New York, Stati Uniti
- Memorial Sloan-Kettering Cancer Center at Commack
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New York, New York, Stati Uniti, 10065
- Memorial Sloan-Kettering Cancer Center
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Sleepy Hollow, New York, Stati Uniti
- Memoral Sloan Kettering Cancer Center@Phelps
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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.
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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. |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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.
Lasso di tempo: 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).
Lasso di tempo: conclusion of study
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conclusion of study
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients).
Lasso di tempo: conclusion of study
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conclusion of study
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Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 08-079
- NIH (Altro numero di sovvenzione/finanziamento: NIDA)
- NCI (HHSN261200700046C)
- R03CA130591-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .