Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00244868|
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : January 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Other: counseling intervention Other: educational intervention||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Official Title:||Facilitating Decision Making in Advanced Cancer Patients|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||April 2007|
- Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation
- Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion
- 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
- Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244868
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Pennsylvania|
|Fox Chase Cancer Center - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|United States, Tennessee|
|MBCCOP - Meharry Medical College - Nashville|
|Nashville, Tennessee, United States, 37208-3599|
|Principal Investigator:||Neal J. Meropol, MD||Fox Chase Cancer Center|