Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
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| ClinicalTrials.gov Identifier: NCT01012401 |
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Recruitment Status :
Completed
First Posted : November 13, 2009
Last Update Posted : November 15, 2019
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Sponsor:
University of Wisconsin, Madison
Collaborators:
Hartford Hospital
M.D. Anderson Cancer Center
University of Illinois at Chicago
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer, Stage IIIb or IV | Other: CHESS website for lung cancer patient + internet access if needed | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 284 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| 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 |
| Actual Study Start Date : | November 2009 |
| Actual Primary Completion Date : | May 15, 2014 |
| Actual Study Completion Date : | May 15, 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: CHESS with Clinician Report + Internet access
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.
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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. |
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Active Comparator: Usual care with Internet access
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
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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. |
Primary Outcome Measures :
- Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life. [ Time Frame: 12-month intervention ]
- Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient. [ Time Frame: 12-month intervention ]
Secondary Outcome Measures :
- Examine the effects of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ]
- Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs. [ Time Frame: 12 mos. ]
- Examine whether these constructs mediate the effects of CHESS use on patient quality of life. [ Time Frame: 12 mos. ]
- Examine whether treatment participation mediates the effect patient quality of life has on survival. [ Time Frame: 12 mos/ ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012401
Locations
| United States, Connecticut | |
| Harry Gray Cancer Center at Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| United States, Illinois | |
| University of Illinois at Chicago Cancer Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Texas | |
| M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| University of Wisconsin Carbone Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Hartford Hospital
M.D. Anderson Cancer Center
University of Illinois at Chicago
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | James Cleary, M.D. | University of Wisconsin, Madison | |
| Principal Investigator: | Lori DuBenske, Ph.D. | University of Wisconsin, Madison |
Additional Information:
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01012401 |
| Other Study ID Numbers: |
M-2009-1223 2P50CA095817-06 ( U.S. NIH Grant/Contract ) XP08517 ( Other Identifier: University of Wisconsin, Madison ) NCI-2011-01004 ( Registry Identifier: NCI Trial ID ) |
| First Posted: | November 13, 2009 Key Record Dates |
| Last Update Posted: | November 15, 2019 |
| Last Verified: | March 2019 |
Keywords provided by University of Wisconsin, Madison:
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Lung cancer Quality of life Communication with physician |
Additional relevant MeSH terms:
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |