Trial Information

Facilitating Decision Making in Advanced Cancer Patients

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.