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

NCT ID: NCT01133132

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2017-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Survivorship CHESS

Intervention Type BEHAVIORAL

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.

Control

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Survivorship CHESS

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David H Gustafson

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hartford Hospital

Hartford, Connecticut, United States

Site Status

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XP08218

Identifier Type: OTHER

Identifier Source: secondary_id

M-2009-1127

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00776

Identifier Type: REGISTRY

Identifier Source: secondary_id

A195000

Identifier Type: OTHER

Identifier Source: secondary_id

ENGR/INDUSTRIAL ENGR

Identifier Type: OTHER

Identifier Source: secondary_id

M-2009-1127

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.