Web-Based Intervention for Lung Cancer Patients and Their Informal Caregivers - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 16, 2006

Last Updated Date

December 21, 2007

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Caregiver affect and adjustment [ Time Frame: 1 year post patient death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00365963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Clinician-Patient-Caregiver Communication [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Web-Based Intervention for Lung Cancer Patients and Their Informal Caregivers

Official Title ^†

Clinician Integration Study

Brief Summary

The purpose of this study is to find out if patients with lung cancer and their main informal caregiver (person providing physical, emotional, or financial support) are helped by getting information, support, and decision making tools through a computer system called CHESS(the Comprehensive Health Enhancement Support System)

Detailed Description

Many patients and their family/friends use the internet for obtaining information regarding the cancer diagnosis and treatment. In this study, the main caregiver of patients with advance (stage III or IV) non-small cell lung cancer is provided with a computer and internet access. Approximately one-half of the participants will also receive CHESS.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study

Condition ^†

Non-Small Cell Lung Cancer

Intervention ^†

Device: Comprehensive Health Enhancement Support System

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

252

Estimated Completion Date

May 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Advanced Non-Small Cell Lung Cancer (Stage III or Stage IV)
Needs to have a "caregiver" - a spouse, partner, family member, or friend providing emotional, physical, and/or financial support - to participate with the patient.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00365963

Responsible Party

David Gustafason, School of engineering

Secondary IDs ^††

NCI#5 P50 CA095817-03

Study Sponsor ^†

University of Wisconsin, Madison

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

David H Gustafson, PhD

Center for Health Systems Research and Analysis

Information Provided By

University of Wisconsin, Madison

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.