Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors
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ClinicalTrials.gov Identifier: NCT01133132 |
Recruitment Status :
Completed
First Posted : May 28, 2010
Last Update Posted : November 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Behavioral: Survivorship CHESS Other: Control | Not Applicable |
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 |

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.
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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.
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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. |
- 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).

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133132
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 |
Principal Investigator: | David H Gustafson | University of Wisconsin, Madison |
Additional Information:
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 Key Record Dates |
Last Update Posted: | November 18, 2019 |
Last Verified: | February 2018 |
Colon cancer patients who have completed treatment |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |