MDACC Study Summary 2009-0448

Study Summary
No. 2009-0448:.......Cancer Prevention; Colorectum......Cindy L. Carmack......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0448

Study Title:	Interactive Cancer Communication Systems Directed Physical Activity Enhancement for Colon Cancer Survivors

Physician

New Patient Referral



Name:	Cindy L. Carmack	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3582 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention Colorectum	Supported By:	NCI

Phase of Study:	N/A	Return Visit:	Training on how to use the smart phone will be required for the intervention group, but may be completed via phone.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to learn if an investigational "Smart Phone" program can help patients to increase their physical activity level, compared to patients who are not using the Smart Phone. This will be measured over a 9-month period in patients who have colon cancer.

Study Objectives / Outcomes

The specific aims of this exploratory study, which is a collaborative effort between investigators at the University of North Carolina, the University of Wisconsin, and the M. D. Anderson Cancer Center (MDACC), are as follows:

Primary Aim: To determine whether stage I-III colon cancer survivors who are randomized to Survivorship CHESS (a Comprehensive Health Enhancement Support System (CHESS) or smart phone intervention aimed at promoting increased physical activity), 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 (month) follow-up).
Secondary Aims:

To examine 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 durability in physical activity long-term, e.g., from baseline to 9 M follow-up (3 M after the intervention period is complete).
To examine whether stage I-III colon cancer survivors who are randomized to Survivorship CHESS, as compared to those who are assigned to usual care, demonstrate significant improvements in secondary outcomes, such as improved weight status (healthy range for body mass index or BMI is >18.5 to <24.9), decreased distress, and improved quality of life.
To examine associations between various moderators (gender, age, socio-economic status, cancer stage and treatment, and comorbidity) and intervention efficacy to increase physical activity.
To examine associations between various mediators (Survivorship CHESS use, autonomy, competence, and relatedness) and intervention efficacy to increase physical activity.

Study Status Information



Study Activation / Registration Date:	05/25/2010

IRB Review and Approval Date:	05/25/2010

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	294

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Men or women diagnosed with local or regional colon cancer (Stage I, II, or III)

2) Diagnosed with colon cancer within the previous 12 months with no evidence of recurrence or new cancers

3) At least 18 years of age

4) Able to speak and read English

5) 6th grade or higher educational level

6) Willing to be randomized into the control or intervention arm and to undergo baseline and follow-up assessments

Exclusion Criteria:

1) Evidence of progressive colon cancer

2) Pre-existing medical conditions(s) that preclude adherence to an unsupervised exercise program, which includes survivors with severe orthopedic conditions or scheduled for a hip or knee replacement within six months; paralysis; end-stage renal disease; dementia; as well as survivors 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

3) Engaged in moderate to vigorous physical activity of 150 minutes/week or more

4) Residing in institutional settings, e.g., living in assisted or skilled nursing facilities, and therefore not able to make independent choices about their lifestyle behaviors nor to participate fully in the intervention

5) Currently pregnant

Links

Registration Number: Not Applicable Clinical Trial