- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00244868
Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer
Facilitating Decision Making in Advanced Cancer Patients
RATIONALE: A computer-based survey and communication aid may help physicians and patients to communicate better and help make treatment decisions easier.
PURPOSE: This phase III randomized clinical trial is studying how well giving a computer-based survey together with a communication aid works compared to a computer-based survey alone in improving physician-patient communication and treatment decision making in patients with metastatic cancer.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- Compare satisfaction with physician-patient communication and decisional conflict in patients with metastatic cancer undergoing a computer-based survey with vs without a communication aid.
- Compare patient expectations regarding potential benefits and adverse reactions associated with treatment options in patients undergoing the computer-based survey and communication aid.
- Compare the content of physician-patient consultations in patients undergoing the computer-based survey and communication aid.
OUTLINE: This is a randomized, controlled, multicenter study.
Patients are randomized to 1 of 3 study arms.
- Arm I (generic computer-based survey): Patients complete a 45- to 60-minute generic computer-based survey that assesses demographics, familiarity and comfort with computers, treatment history, and affective elements.
- Arm II (targeted computer-based survey and communication aid with physician summary report): Patients complete a 45- to 60-minute targeted computer-based survey assessing patient values, information needs, and distress. Patients then complete a targeted computer-based communication aid that addresses cognitive and affective components of cancer treatment education and provides communication skills training. After completion of the survey and communication aid, a summary report of the survey results is generated and provided to the patient's physician.
- Arm III (targeted computer-based survey and communication aid): Patients complete a targeted computer-based survey and communication aid as in arm II. No summary report is provided to the physician.
After completion of a computer-based survey and communication aid, all patients undergo a consultation with their physician. A randomized subset of 25% of physician consultations* are audiotaped and later analyzed. Patients complete a 15-minute written survey after completion of the physician consultation and then at 3 months.
NOTE: *Patients are stratified according to study arm (I vs II vs III) and consulting physician gender for this randomization.
PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37208-3599
- MBCCOP - Meharry Medical College - Nashville
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Documented metastatic malignancy
- First visit with medical oncologist at study site
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to read and speak English
PRIOR CONCURRENT THERAPY: Not specified
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation
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Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion
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Expectations regarding potential benefits and adverse reactions associated with treatment options by Treatment Options Expectations Scale given immediately after the first consultation and at 3 months after study completion
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Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Neal J. Meropol, MD, Fox Chase Cancer Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000442928
- FCCC-03826
- FCCC-NCI-FC03CC9
- NU-119-385
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 .