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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Stage IIIb or IV

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.

Outcome Time Frame:

12-month intervention

Safety Issue:

No

Principal Investigator

James Cleary, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2-P50-CA095817-06

NCT ID:

NCT01012401

Start Date:

November 2009

Completion Date:

April 2014

Related Keywords:

  • Lung Cancer, Stage IIIb or IV
  • Lung cancer
  • Quality of life
  • Communication with physician
  • Lung Neoplasms

Name

Location

University of Illinois at Chicago Cancer CenterChicago, Illinois  60612
M.D. Anderson Cancer CenterHouston, Texas  77030
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669
Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102