- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01012401
Evaluating an Interactive Cancer Communication System (ICCS) in Lung Cancer
13 november 2019 bijgewerkt door: University of Wisconsin, Madison
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
284
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Connecticut
-
Hartford, Connecticut, Verenigde Staten, 06102
- Harry Gray Cancer Center at Hartford Hospital
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois at Chicago Cancer Center
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- M.D. Anderson Cancer Center
-
-
Wisconsin
-
Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Carbone Cancer Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
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.
|
Actieve vergelijker: Usual care with Internet access
Control group patients will be given a list of URLs for 10-high quality lung cancer-related sites
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Compared to a Usual Care control, CHESS will significantly improve lung cancer patient Quality of Life.
Tijdsspanne: 12-month intervention
|
12-month intervention
|
Compared to a Usual Care control, CHESS will significantly improve patient influence length of survival of lung cancer patient.
Tijdsspanne: 12-month intervention
|
12-month intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Examine the effects of CHESS use on self-determination theory (SDT) constructs.
Tijdsspanne: 12 mos.
|
12 mos.
|
Examine the factors that moderate effect of CHESS use on self-determination theory (SDT) constructs.
Tijdsspanne: 12 mos.
|
12 mos.
|
Examine whether these constructs mediate the effects of CHESS use on patient quality of life.
Tijdsspanne: 12 mos.
|
12 mos.
|
Examine whether treatment participation mediates the effect patient quality of life has on survival.
Tijdsspanne: 12 mos/
|
12 mos/
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: James Cleary, M.D., University of Wisconsin, Madison
- Hoofdonderzoeker: Lori DuBenske, Ph.D., University of Wisconsin, Madison
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 november 2009
Primaire voltooiing (Werkelijk)
15 mei 2014
Studie voltooiing (Werkelijk)
15 mei 2014
Studieregistratiedata
Eerst ingediend
10 november 2009
Eerst ingediend dat voldeed aan de QC-criteria
12 november 2009
Eerst geplaatst (Schatting)
13 november 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 november 2019
Laatste update ingediend die voldeed aan QC-criteria
13 november 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M-2009-1223
- 2P50CA095817-06 (Subsidie/contract van de Amerikaanse NIH)
- XP08517 (Andere identificatie: University of Wisconsin, Madison)
- NCI-2011-01004 (Register-ID: NCI Trial ID)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Lung Cancer, Stage IIIb or IV
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
Jonsson Comprehensive Cancer CenterWervingProstaat Adenocarcinoom | Stadium IV prostaatkanker AJCC v8 | Stadium IIIC prostaatkanker AJCC v8 | Stadium IVA Prostaatkanker AJCC v8 | Stadium IVB Prostaatkanker AJCC v8 | Stadium IIIB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
National Cancer Institute (NCI)BeëindigdRefractair maligne solide neoplasma | Recidiverend maligne solide neoplasma | Gemetastaseerd maligne solide neoplasma | Inoperabel solide neoplasma | Recidiverend kleincellig longcarcinoom | Stadium IIIA Kleincellig longcarcinoom AJCC v7 | Stadium IIIB Kleincellig longcarcinoom AJCC v7 | Stadium... en andere voorwaardenVerenigde Staten