Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, metastatic cancer
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.
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
| Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation | — |
| Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation | — |
Countries
United States