Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Health Enhancement Support System
Sponsored by
About this trial
This is an interventional other trial for Non-Small Cell Lung Cancer focused on measuring lung cancer, caregivers, support, resources, education
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.
Sites / Locations
- University of Wisconsin- Madison 610 Walnut St, WARF 1109A
Outcomes
Primary Outcome Measures
Caregiver affect and adjustment
Secondary Outcome Measures
Clinician-Patient-Caregiver Communication
Full Information
NCT ID
NCT00365963
First Posted
August 16, 2006
Last Updated
September 28, 2021
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00365963
Brief Title
Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
Official Title
Clinician Integration Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
lung cancer, caregivers, support, resources, education
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Comprehensive Health Enhancement Support System
Intervention Description
computer based support and education
Primary Outcome Measure Information:
Title
Caregiver affect and adjustment
Time Frame
1 year post patient death
Secondary Outcome Measure Information:
Title
Clinician-Patient-Caregiver Communication
Time Frame
throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Gustafson, PhD
Organizational Affiliation
Center for Health Systems Research and Analysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin- Madison 610 Walnut St, WARF 1109A
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29138131
Citation
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.
Results Reference
result
PubMed Identifier
24245838
Citation
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.
Results Reference
derived
PubMed Identifier
22988042
Citation
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.
Results Reference
derived
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Web-based Intervention for Lung Cancer Patients and Their Informal Caregivers
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