- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
-
-
Tennessee
-
Nashville, Tennessee, United States, 37208-3599
- MBCCOP - Meharry Medical College - Nashville
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neal J. Meropol, MD, Fox Chase Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000442928
- FCCC-03826
- FCCC-NCI-FC03CC9
- NU-119-385
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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