Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
Primary Purpose
Lung Cancer, Stage IIIb or IV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHESS website for lung cancer patient + internet access if needed
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer, Stage IIIb or IV focused on measuring Lung cancer, Quality of life, Communication with physician
Eligibility Criteria
Inclusion Criteria:
- All patients must be diagnosed with non-small cell lung cancer (Stage IIIA non surgical, IIIB or IV)
- All patients must be within 12 months of their primary lung cancer diagnosis or metastatic or recurrence disease.
- All patients must be at least 18 years of age,
- All patients must have an ECOG Performance Status rating of level 0, 1 or 2.
- If patients have brain metastases, they must be stable
- All patients must be under the care of a clinician who has consented to participate in the study.
- All patients must be able to speak and read English (educational attainment of at least 6th grade).
- All patients will be invited to have a caregiver also participate in the study, however this is not required.
Sites / Locations
- Harry Gray Cancer Center at Hartford Hospital
- University of Illinois at Chicago Cancer Center
- M.D. Anderson Cancer Center
- University of Wisconsin Carbone Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHESS with Clinician Report + Internet access
Usual care with Internet access
Arm Description
An Internet-based system, Comprehensive Health Enhancement Support System for Lung Cancer(CHESS-LC) integrates over 14 services to provide tailored cancer information, support, and interactive tools.
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
Outcomes
Primary Outcome Measures
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
Secondary Outcome Measures
Examine the effects of CHESS use on self-determination theory (SDT) constructs.
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
Examine whether treatment participation mediates the effect patient quality of life has on survival.
Full Information
NCT ID
NCT01012401
First Posted
November 10, 2009
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Hartford Hospital, M.D. Anderson Cancer Center, University of Illinois at Chicago, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01012401
Brief Title
Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
Official Title
Interactive Cancer Communication System (ICCS) in Lung Cancer: Evaluating Survival Benefits. Center of Excellence in Cancer Communication Research: Using Technology to Enhance Cancer Communication and Improve Clinical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
May 15, 2014 (Actual)
Study Completion Date
May 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Hartford Hospital, M.D. Anderson Cancer Center, University of Illinois at Chicago, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine the potential for an Interactive Cancer Communication System (ICCS) to impact not only psychosocial outcomes such as quality of life but also length of survival in an advanced stage lung cancer population. Two hypotheses will be tested: the Comprehensive Health Enhancement Support System- Lung Cancer (CHESS- LC) will significantly improve patient quality of life and length of overall survival as compared to a usual care control group.
Detailed Description
The prognosis for Non-Small Cell Lung Cancer patients remains poor despite recent advances in anti-cancer therapies. A lung cancer diagnosis often inflicts fear, despair, and hopelessness on patients and loved ones. For lung cancer patients in particular, a population where palliation rather than cure is often the focus, interventions addressing communication about various types of suffering are crucial to quality of life (QOL). Our Center has done extensive research testing CHESS (Comprehensive Health Enhancement Support System), a non-commercial, web-based information and support system. The recent Clinician Integration Project tested the impact of CHESS versus an Internet only Control group on QOL for caregivers of advanced stage lung cancer patients. This study yielded an unanticipated finding that CHESS may have a survival benefit for patients as one year survival was significantly increased in the CHESS group (50%) compared to Internet (34.2%). As this project did not focus on patient outcomes, follow-up with a well-formulated study designed and powered to address specific hypotheses of the nature of this effect is critical. The proposed study will specifically test QOL and survival effects of CHESS on lung cancer patients. Using sites in Wisconsin, Connecticut,Houston, and Chicago, we will randomly assign 376 advanced lung cancer patients to two study arms: a patient control group receiving Usual Care (including access to a computer and Internet) and a group given access to the CHESS website. Patients may invite a caregiver to participate. Patients will be followed for 18 months or until patient death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Stage IIIb or IV
Keywords
Lung cancer, Quality of life, Communication with physician
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHESS with Clinician Report + Internet access
Arm Type
Experimental
Arm Description
An Internet-based system, Comprehensive Health Enhancement Support System for Lung Cancer(CHESS-LC) integrates over 14 services to provide tailored cancer information, support, and interactive tools.
Arm Title
Usual care with Internet access
Arm Type
Active Comparator
Arm Description
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
Intervention Type
Other
Intervention Name(s)
CHESS website for lung cancer patient + internet access if needed
Intervention Description
The Comprehensive Health Enhancement Support System (CHESS), a non-commercial, home-based system created by clinical, communication, and decision scientists at the University of Wisconsin, is distinguished by its quality, depth, and ease of use. It employs data on user health status to help users monitor their condition, guide them to tailored information and social support, make and implement important health decisions, and learn coping skills. Our tests and clinical trials demonstrate that an ICCS such as CHESS can be widely accepted and used, improve quality of life, information competence, and in some cases lead to more efficient use of health services. An Internet-based system, CHESS-LC integrates over 14 services to provide tailored cancer information, support, interactive tools, and communication with the clinical team.
Primary Outcome Measure Information:
Title
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
Time Frame
12-month intervention
Title
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
Time Frame
12-month intervention
Secondary Outcome Measure Information:
Title
Examine the effects of CHESS use on self-determination theory (SDT) constructs.
Time Frame
12 mos.
Title
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
Time Frame
12 mos.
Title
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
Time Frame
12 mos.
Title
Examine whether treatment participation mediates the effect patient quality of life has on survival.
Time Frame
12 mos/
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must be diagnosed with non-small cell lung cancer (Stage IIIA non surgical, IIIB or IV)
All patients must be within 12 months of their primary lung cancer diagnosis or metastatic or recurrence disease.
All patients must be at least 18 years of age,
All patients must have an ECOG Performance Status rating of level 0, 1 or 2.
If patients have brain metastases, they must be stable
All patients must be under the care of a clinician who has consented to participate in the study.
All patients must be able to speak and read English (educational attainment of at least 6th grade).
All patients will be invited to have a caregiver also participate in the study, however this is not required.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Cleary, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lori DuBenske, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harry Gray Cancer Center at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
University of Illinois at Chicago Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
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