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

Study Overview
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Brief Summary
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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.

Official Title
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ICCS Directed Physical Activity Enhancement for Colon Cancer Survivors

Conditions
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Colon Cancer

Intervention / Treatment
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* Behavioral: Survivorship CHESS
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* 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.<br>Other: Control<br>* 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.<br>|
| Experimental: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon cancer patients who have completed treatment