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Facilitating Decision Making in Advanced Cancer Patients


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Facilitating Decision Making in Advanced Cancer Patients


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Outcome Measure:

Satisfaction with patient-physician communication by Medical Interview Satisfaction Survey and Face Valid Survey given immediately after the first consultation

Safety Issue:

No

Principal Investigator

Neal J. Meropol, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000442928

NCT ID:

NCT00244868

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • metastatic cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599