Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Facilitating Decision Making in Advanced Cancer Patients

Conditions
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Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: counseling intervention
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Other: educational intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, metastatic cancer