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

• ClinicalTrials.gov Identifier: NCT01133132
• Recruitment Status: Completed
• First Posted: May 28, 2010
• Last Update Posted: November 18, 2019
• 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

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colon Cancer	Behavioral: Survivorship CHESS; Other: Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: ICCS Directed Physical Activity Enhancement for Colon Cancer Survivors
• Study Start Date: February 2010
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: September 18, 2017

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in level of physical activity [ Time Frame: 6 M intervention period ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Connecticut

Hartford Hospital

Hartford, Connecticut, United States, 06120

United States, North Carolina

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, United States, 27599

United States, Texas

M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

University of Wisconsin, Madison

University of North Carolina, Chapel Hill

M.D. Anderson Cancer Center

Hartford Hospital

Investigators

• Principal Investigator: David H Gustafson; University of Wisconsin, Madison

More Information

Additional Information:

University of Wisconsin Carbone Cancer Center 

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01133132 History of Changes
• Other Study ID Numbers: M-2009-1127; XP08218 ( Other Identifier: University of Wisconsin Carbone Cancer Center ); M-2009-1127 ( Other Identifier: Institutional Review Board ); NCI-2011-00776 ( Registry Identifier: NCI Trial ID ); A195000 ( Other Identifier: UW Madison ); ENGR/INDUSTRIAL ENGR ( Other Identifier: UW Madison )
• First Posted: May 28, 2010
• Last Update Posted: November 18, 2019
• Last Verified: February 2018

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; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases