Trial record 1 of 1 for:    CHESS and colon cancer
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Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
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: January 6, 2014
Last verified: January 2014

May 26, 2010
January 6, 2014
February 2010
December 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01133132 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Colon Cancer
  • 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.
  • 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.
  • Placebo Comparator: 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.
    Interventions:
    • Behavioral: Survivorship CHESS
    • Other: Control
  • 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.
    Intervention: Behavioral: Survivorship CHESS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
294
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01133132
XP08218
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
  • University of North Carolina, Chapel Hill
  • M.D. Anderson Cancer Center
  • Hartford Hospital
Not Provided
University of Wisconsin, Madison
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP