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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	counseling intervention
OTHER	educational intervention

Timeline

• Start date: 2003-07-01
• Primary completion: 2007-04-01
• First posted: 2005-10-27
• Last updated: 2013-01-29

Locations

3 sites across 1 country: United States