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

Not Applicable
Completed
Conditions
Lung Cancer, Stage IIIb or IV
Interventions
Other: CHESS website for lung cancer patient + internet access if needed
Registration Number
NCT01012401
Lead Sponsor
University of Wisconsin, Madison
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
284
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.
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CHESS with Clinician Report + Internet accessCHESS website for lung cancer patient + internet access if neededAn 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.
Usual care with Internet accessCHESS website for lung cancer patient + internet access if neededControl group patients will be given a list of URLs for 10-high quality lung cancer-related sites
Primary Outcome Measures
NameTimeMethod
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.12-month intervention
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.12-month intervention
Secondary Outcome Measures
NameTimeMethod
Examine the effects of CHESS use on self-determination theory (SDT) constructs.12 mos.
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.12 mos.
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.12 mos.
Examine whether treatment participation mediates the effect patient quality of life has on survival.12 mos/

Trial Locations

Locations (4)

University of Wisconsin Carbone Cancer Center

🇺🇸

Madison, Wisconsin, United States

Harry Gray Cancer Center at Hartford Hospital

🇺🇸

Hartford, Connecticut, United States

M.D. Anderson Cancer Center

🇺🇸

Houston, Texas, United States

University of Illinois at Chicago Cancer Center

🇺🇸

Chicago, Illinois, United States

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