Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors

Colon Cancer Clinical Trial

Official title:

ICCS Directed Physical Activity Enhancement for Colon Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133132
• Other study ID #: M-2009-1127
• Secondary ID: XP08218M-2009-11
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: September 18, 2017

Study information

• Verified date: February 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 18, 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina- Chapel Hill	Chapel Hill	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	M.D. Anderson Cancer Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Hartford Hospital, M.D. Anderson Cancer Center, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of physical activity	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).	6 M intervention period

External Links

•   University of Wisconsin Carbone Cancer Center