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
18 Years
N/A
Both
Lung Cancer, Stage IIIb or IV
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 Center | Chicago, Illinois 60612 |
| M.D. Anderson Cancer Center | Houston, Texas 77030 |
| University of Wisconsin Carbone Cancer Center | Madison, Wisconsin 53792-5669 |
| Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102 |
