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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00244868
First received: October 25, 2005
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Other: counseling intervention
Other: educational intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Facilitating Decision Making in Advanced Cancer Patients

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation [ Designated as safety issue: No ]
  • Assess decisional conflict by Decisional Conflict Scale immediately after the first consultation and at 3 months after study completion [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: Yes ]
  • Assess content of consultation by applying a coding scheme to transcripts and design yes/no questions immediately after the first consultation [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: July 2003
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244868

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208-3599
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Neal J. Meropol, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00244868     History of Changes
Other Study ID Numbers: CDR0000442928, FCCC-03826, FCCC-NCI-FC03CC9, NU-119-385
Study First Received: October 25, 2005
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
unspecified adult solid tumor, protocol specific
metastatic cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014