Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244868
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2005-10-25
Brief Title:
Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Facilitating Decision Making in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-119-385 | None | None | None |
| FCCC-03826 | None | None | None |
| FCCC-NCI-FC03CC9 | None | None | None |