Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
September 28, 2021 updated by: University of Wisconsin, Madison
Clinician Integration Study
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
284
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin- Madison 610 Walnut St, WARF 1109A
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Caregiver affect and adjustment
Time Frame: 1 year post patient death
|
1 year post patient death
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinician-Patient-Caregiver Communication
Time Frame: throughout study
|
throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David H Gustafson, PhD, Center for Health Systems Research and Analysis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gustafson DH, DuBenske LL, Atwood AK, Chih MY, Johnson RA, McTavish F, Quanbeck A, Brown RL, Cleary JF, Shah D. Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials. J Med Internet Res. 2017 Nov 14;19(11):e354. doi: 10.2196/jmir.7466.
- DuBenske LL, Gustafson DH, Namkoong K, Hawkins RP, Atwood AK, Brown RL, Chih MY, McTavish F, Carmack CL, Buss MK, Govindan R, Cleary JF. CHESS improves cancer caregivers' burden and mood: results of an eHealth RCT. Health Psychol. 2014 Oct;33(10):1261-72. doi: 10.1037/a0034216. Epub 2013 Nov 18.
- Chih MY, DuBenske LL, Hawkins RP, Brown RL, Dinauer SK, Cleary JF, Gustafson DH. Communicating advanced cancer patients' symptoms via the Internet: a pooled analysis of two randomized trials examining caregiver preparedness, physical burden, and negative mood. Palliat Med. 2013 Jun;27(6):533-43. doi: 10.1177/0269216312457213. Epub 2012 Sep 17.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
August 16, 2006
First Submitted That Met QC Criteria
August 16, 2006
First Posted (Estimate)
August 18, 2006
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-191X
- ENGR/INDUSTRIAL ENGR (Other Identifier: UW Madison)
- 5P50CA095817-03 (U.S. NIH Grant/Contract)
- CC04315 (Other Identifier: University of Wisconsin Carbone Cancer Center)
- 2003-191 (Other Identifier: Institutional Review Board)
- A195000 (Other Identifier: UW Madison)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.