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

Lung Cancer, Stage IIIb or IV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012401
• Other study ID #: M-2009-1223
• Secondary ID: 2P50CA095817-06X
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: May 15, 2014

Study information

• Verified date: March 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: May 15, 2014
• Est. primary completion date: May 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer, Stage IIIb or IV
• Lung Neoplasms

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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago Cancer Center	Chicago	Illinois
United States	Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Hartford Hospital, M.D. Anderson Cancer Center, National Cancer Institute (NCI), University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.		12-month intervention
Primary	Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.		12-month intervention
Secondary	Examine the effects of CHESS use on self-determination theory (SDT) constructs.		12 mos.
Secondary	Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.		12 mos.
Secondary	Examine whether these constructs mediate the effects of CHESS use on patient quality of life.		12 mos.
Secondary	Examine whether treatment participation mediates the effect patient quality of life has on survival.		12 mos/

External Links

•   Link