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

University of Wisconsin (UW)

Status: Completed

Conditions: Lung Cancer, Stage IIIb or IV

Treatments: Other: CHESS website for lung cancer patient + internet access if needed

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01012401

XP08517 (Other Identifier)

M-2009-1223

NCI-2011-01004 (Registry Identifier)

2P50CA095817-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

CHESS with Clinician Report + Internet access

Experimental group

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.

Treatment:

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

Usual care with Internet access

Active Comparator group

Description:

Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites

Treatment:

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