- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01133132
Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors
14 november 2019 uppdaterad av: University of Wisconsin, Madison
ICCS Directed Physical Activity Enhancement for Colon Cancer Survivors
This study will develop and test the benefits of a new ICCS (Interactive Cancer Communication System), a mobile Comprehensive Health Enhancement Support System (Survivorship CHESS) in colon cancer survivors.
Survivorship CHESS will provide information, tools, and a support system based on our previous work with FRESH START and CHESS, two highly successful interventions that have promoted lifestyle change among cancer patients and survivors.
Survivorship CHESS will be designed to help subjects develop 1) competence in information gathering, decision-making, and behaviors they are trying to change, 2) social support systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a sense of control over their lives; this in turn, will help them adopt or maintain healthy lifestyle behaviors and improve their quality of life.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06120
- Hartford Hospital
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina- Chapel Hill
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Texas
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Houston, Texas, Förenta staterna, 77030
- M.D. Anderson Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Diagnosis of stage I-III loco-regional colon cancer within the previous 12 months with no evidence of recurrence or new cancers. Participants may be recruited at any time after the initial diagnosis (up to 12 months). Baseline data collection will occur no earlier than 6 weeks after completion of adjuvant treatment
- At least 21 years of age
- Able to speak and read English (educational attainment of at lease 6th grade)
- Engaged in physical activities less than 8 metabolic equivalent tasks (METs) per week
- Not Homeless
Exclusion Criteria:
- Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program which includes subjects with severe orthopedic conditions or scheduled for a hip or knee replacement within six months; paralysis; end-stage renal disease; dementia; as well as subjects who have unstable angina or who have experienced a heart attack; congestive heart failure or pulmonary conditions that require oxygen or hospitalization within six months; or uncorrected vision or hearing problems or other ergonomic conditions that would preclude the use of the smart phone.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Control
This person will receive usual care and a copy of the National Cancer Institute's Facing Forward booklet and the National Cancer Center Network cancer survivor toolbox.
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Once the consent, baseline survey and one week accelerometer data is received by the UW research team subjects will be randomized to one of the two study conditions.
Subjects will be notified of their randomization.
Subjects randomized to the Survivorship CHESS condition will be offered training on the smartphone and the CHESS system.
The project director (and site research coordinators) will provide training on the smartphone either in person or over the phone.
Additionally, an online tutorial will be included in the Survivorship CHESS intervention for subjects to refer to as needed.
Participants will then be asked to complete four surveys one baseline and then three follow up surveys.
This person will receive usual care and a copy of the National Cancer Institute's Facing Forward booklet and the National Cancer Center Network cancer survivor toolbox.
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Experimentell: Intervention
For those subjects randomized to the Survivorship CHESS condition they will receive a smartphone and access to a web based information system that provides access to clinical information about colon cancer treatment, survivorship, exercise planning and tracking functions to allow these subjects to monitor their self defined exercise goals and objectives.
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Once the consent, baseline survey and one week accelerometer data is received by the UW research team subjects will be randomized to one of the two study conditions.
Subjects will be notified of their randomization.
Subjects randomized to the Survivorship CHESS condition will be offered training on the smartphone and the CHESS system.
The project director (and site research coordinators) will provide training on the smartphone either in person or over the phone.
Additionally, an online tutorial will be included in the Survivorship CHESS intervention for subjects to refer to as needed.
Participants will then be asked to complete four surveys one baseline and then three follow up surveys.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in level of physical activity
Tidsram: 6 M intervention period
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To determine whether stage I-III colon cancer survivors who are randomized to Survivorship CHESS, as compared to those who are assigned to usual care, demonstrate significantly greater increases in levels of physical activity from baseline to completion of the intervention (6 M intervention period).
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6 M intervention period
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David H Gustafson, University of Wisconsin, Madison
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2010
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
18 september 2017
Studieregistreringsdatum
Först inskickad
26 maj 2010
Först inskickad som uppfyllde QC-kriterierna
27 maj 2010
Första postat (Uppskatta)
28 maj 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 november 2019
Senast verifierad
1 februari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M-2009-1127 (Annan identifierare: Institutional Review Board)
- ENGR/INDUSTRIAL ENGR (Annan identifierare: UW Madison)
- A195000 (Annan identifierare: UW Madison)
- XP08218 (Annan identifierare: University of Wisconsin Carbone Cancer Center)
- NCI-2011-00776 (Registeridentifierare: NCI Trial ID)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Koloncancer
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Royal Marsden NHS Foundation TrustPelican Cancer FoundationAvslutadSigmoid, Sigmoid Colon, Neoplasm, CancerStorbritannien
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Ningbo No. 1 HospitalAvslutad
-
Massachusetts General HospitalAvslutad
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The University of Hong KongQueen Mary Hospital, Hong KongAvslutad
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Singapore General HospitalOkänd
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Hospital Universitario de CanariasOkänd
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Technical University of MunichAvslutad
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Changhai HospitalXiangya Hospital of Central South University; Fudan University; Xuzhou Central... och andra samarbetspartnersRekrytering
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Soonchunhyang University HospitalAvslutad
-
The University of Hong KongAvslutad
Kliniska prövningar på Survivorship CHESS
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Debra FriedmanNational Cancer Institute (NCI)Aktiv, inte rekryterande
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University of Wisconsin, MadisonNational Institute of Nursing Research (NINR)Avslutad
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University of Wisconsin, MadisonNational Institutes of Health (NIH)Avslutad
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University College CorkSidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Cork University... och andra samarbetspartnersAktiv, inte rekryterandeLivmoderhalscancer | Bröstcancer | Endometriecancer | ÖverlevnadIrland
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Jewish General HospitalRekrytering
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Massachusetts General HospitalHar inte rekryterat ännuSömnlöshet | Canceröverlevnad
-
University of Wisconsin, MadisonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Avslutad
-
Baylor College of MedicineThe University of Texas Health Science Center, Houston; University of Texas... och andra samarbetspartnersRekryteringLivskvalité | Depressiva symtom | Ovarial neoplasmFörenta staterna
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University of Wisconsin, MadisonNational Cancer Institute (NCI)Avslutad
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Duke UniversityNational Cancer Institute (NCI)AvslutadAvancerad cancerFörenta staterna