Clinical trial NCT00244868: Computer-Based Survey and Communication Aid in Improving Physician-Patient Communication and Treatment Decision Making in Patients With Metastatic Cancer
Official title: Facilitating Decision Making in Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
metastatic cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-27
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

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.

Eligibility 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

Primary outcomes:
measure: Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation
measure: Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion
measure: 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
measure: Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: MBCCOP - Meharry Medical College - Nashville
state: Tennessee
Study officials:
affiliation: Fox Chase Cancer Center
name: Neal J. Meropol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meropol NJ, Egleston BL, Buzaglo JS, Benson AB 3rd, Cegala DJ, Diefenbach MA, Fleisher L, Miller SM, Sulmasy DP, Weinfurt KP; CONNECT Study Research Group. Cancer patient preferences for quality and length of life. Cancer. 2008 Dec 15;113(12):3459-66. doi: 10.1002/cncr.23968.