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Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Harry Gray Cancer Center, Hartford Hospital
M.D. Anderson Cancer Center
University of Illinois at Chicago
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01012401
First received: November 10, 2009
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Lung Cancer, Stage IIIb or IV
Other: CHESS website for lung cancer patient + internet access if needed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life. [ Time Frame: 12-month intervention ] [ Designated as safety issue: No ]
  • Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient. [ Time Frame: 12-month intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine the effects of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ] [ Designated as safety issue: No ]
  • Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ] [ Designated as safety issue: No ]
  • Examine whether these constructs mediate the effects of CHESS use on patient quality of life. [ Time Frame: 12 mos. ] [ Designated as safety issue: No ]
  • Examine whether treatment participation mediates the effect patient quality of life has on survival. [ Time Frame: 12 mos/ ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: November 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHESS with Clinician Report + Internet access
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.
Other: CHESS website for lung cancer patient + internet access if needed
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.
Active Comparator: Usual care with Internet access
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
Other: CHESS website for lung cancer patient + internet access if needed
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012401

Locations
United States, Connecticut
Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Illinois
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Harry Gray Cancer Center, Hartford Hospital
M.D. Anderson Cancer Center
University of Illinois at Chicago
Investigators
Principal Investigator: James Cleary, M.D. University of Wisconsin, Madison
Principal Investigator: Lori DuBenske, Ph.D. University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01012401     History of Changes
Other Study ID Numbers: 2-P50-CA095817-06
Study First Received: November 10, 2009
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Lung cancer
Quality of life
Communication with physician

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014