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

• ClinicalTrials.gov Identifier: NCT01012401
• Recruitment Status: Completed
• First Posted: November 13, 2009
• Last Update Posted: November 15, 2019
• Sponsor: University of Wisconsin, Madison
• Collaborators: Hartford Hospital; M.D. Anderson Cancer Center; University of Illinois at Chicago; National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Wisconsin, Madison

Tracking Information

• First Submitted Date: November 10, 2009
• First Posted Date: November 13, 2009
• Last Update Posted Date: November 15, 2019
• Actual Study Start Date: November 2009
• Actual Primary Completion Date: May 15, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 12, 2009)

• Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life. [ Time Frame: 12-month intervention ]
• Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient. [ Time Frame: 12-month intervention ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 12, 2009)

• Examine the effects of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ]
• Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ]
• Examine whether these constructs mediate the effects of CHESS use on patient quality of life. [ Time Frame: 12 mos. ]
• Examine whether treatment participation mediates the effect patient quality of life has on survival. [ Time Frame: 12 mos/ ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Lung Cancer, Stage IIIb or IV

Intervention

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.

Study Arms

• 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.
  Intervention: Other: CHESS website for lung cancer patient + internet access if needed
• 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
  Intervention: Other: CHESS website for lung cancer patient + internet access if needed

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 18, 2013): 284
• Original Estimated Enrollment (submitted: November 12, 2009): 376
• Actual Study Completion Date: May 15, 2014
• Actual Primary Completion Date: May 15, 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01012401
• Other Study ID Numbers: M-2009-1223; 2P50CA095817-06 ( U.S. NIH Grant/Contract ); XP08517 ( Other Identifier: University of Wisconsin, Madison ); NCI-2011-01004 ( Registry Identifier: NCI Trial ID )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Wisconsin, Madison
• Original Responsible Party: James Cleary and Lori DuBenske, University of Wisconsin Carbone Cancer Center
• Current Study Sponsor: University of Wisconsin, Madison
• Original Study Sponsor: Same as current

Collaborators

• Hartford Hospital
• M.D. Anderson Cancer Center
• University of Illinois at Chicago
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: James Cleary, M.D.; University of Wisconsin, Madison
• Principal Investigator: Lori DuBenske, Ph.D.; University of Wisconsin, Madison

• PRS Account: University of Wisconsin, Madison
• Verification Date: March 2019