NCT00244868

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

October 25, 2005

Last Update Submit

January 28, 2013

Conditions

Keywords

unspecified adult solid tumor, protocol specificmetastatic cancer

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208-3599, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

CounselingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Neal J. Meropol, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

July 1, 2003

Primary Completion

April 1, 2007

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations