Lung Cancer, Stage IIIb or IVNCT01012401
Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
A study testing CHESS website for lung cancer patient + internet access if needed in people with Lung Cancer, Stage IIIb or IV, run by University of Wisconsin, Madison at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Stage IIIb or IV
- What is being tested?
- CHESS website for lung cancer patient + internet access if needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2009to 15 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Illinois at Chicago Cancer Center
Chicago, Illinois, 60612
Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, 06102
M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Cancer, Stage IIIb or IV
- Being tested
- CHESS website for lung cancer patient + internet access if needed
- Keywords
- Lung cancer, Quality of life, Communication with physician
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHESS website for lung cancer patient + internet access if neededOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CHESS with Clinician Report + Internet access | Experimental | 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. Receives: Other: CHESS website for lung cancer patient + internet access if needed |
| Usual care with Internet access | Active comparator | Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites Receives: Other: CHESS website for lung cancer patient + internet access if needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
Measured: 12-month intervention
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
Measured: 12-month intervention
Secondary outcomes (4)
Examine the effects of CHESS use on self-determination theory (SDT) constructs.
Measured: 12 mos.
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
Measured: 12 mos.
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
Measured: 12 mos.
Examine whether treatment participation mediates the effect patient quality of life has on survival.
Measured: 12 mos/
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completion15 May 2014
- Study completion15 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Stage IIIb or IVStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital, M.D. Anderson Cancer Center, University of Illinois Chicago, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Cleary, M.D., Principal investigator, University of Wisconsin, MadisonLori DuBenske, Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012401
- Sponsor's protocol ID
- M-2009-1223
- Other IDs
- 2P50CA095817-06, XP08517, NCI-2011-01004
- Status last verified
- Mar 2019
- First submitted
- 10 Nov 2009
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01012401
- Acronym / sponsor ID
- M-2009-1223
- Conditions
- Lung Cancer, Stage IIIb or IV
- Keywords
- Lung cancer, Quality of life, Communication with physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Hartford Hospital, M.D. Anderson Cancer Center, University of Illinois Chicago, National Cancer Institute (NCI)
- Study start
- Nov 2009 (actual)
- Primary completion
- 15 May 2014 (actual)
- Study completion
- 15 May 2014 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHESS with Clinician Report + Internet access | Experimental | Other: CHESS website for lung cancer patient + internet access if neededAn 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. |
| Usual care with Internet access | Active comparator | Other: CHESS website for lung cancer patient + internet access if neededControl group patients will be given a list of URLs for 10-high quality lung cancer-related sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHESS website for lung cancer patient + internet access if neededThe 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. | Other | CHESS with Clinician Report + Internet access, Usual care with Internet access |
Primary outcome
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
4 secondary outcomes
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/
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cleary, M.D. principal investigator
University of Wisconsin, Madison
Lori DuBenske, Ph.D. principal investigator
University of Wisconsin, Madison
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHESS website for lung cancer patient + internet access if needed in people with Lung Cancer, Stage IIIb or IV, run by University of Wisconsin, Madison at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life. (time frame: 12-month intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.