Trial record 12 of 901 for:
colon cancer | Open Studies
Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors
This study is currently recruiting participants.
Verified November 2011 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Collaborators:
University of North Carolina, Chapel Hill
M.D. Anderson Cancer Center
Hartford Hospital
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01133132
First received: May 26, 2010
Last updated: November 28, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colon Cancer |
Behavioral: Survivorship CHESS Other: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| Official Title: | ICCS Directed Physical Activity Enhancement for Colon Cancer Survivors |
Resource links provided by NLM:
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Change in level of physical activity [ Time Frame: 6 M intervention period ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 294 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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.
|
Other: 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.
|
|
Experimental: 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.
|
Behavioral: Survivorship CHESS
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133132
Contacts
| Contact: Gina M Landucci, B.S. | 608-890-1440 | gina.landucci@chess.wisc.edu |
Locations
| United States, Connecticut | |
| Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 06120 | |
| Contact: Helene McDowell, M.S. helene.mcdowell@chess.wisc.edu | |
| United States, North Carolina | |
| University of North Carolina- Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Helene McDowell, M.S. helene.mcdowell@chess.wisc.edu | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Helene McDowell, M.S. helene.mcdowell@chess.wisc.edu | |
Sponsors and Collaborators
University of Wisconsin, Madison
University of North Carolina, Chapel Hill
M.D. Anderson Cancer Center
Hartford Hospital
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01133132 History of Changes |
| Other Study ID Numbers: | XP08218 |
| Study First Received: | May 26, 2010 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Colon cancer patients who have completed treatment |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013