Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00977613
First received: September 15, 2009
Last updated: March 1, 2011
Last verified: March 2011
Results First Received: November 30, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Condition: Colorectal Cancer (CRC)
Intervention: Behavioral: exercise counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrolled subjects were ambulatory patients completing treatment for colorectal cancer (CRC) from April 2007 through August 2009 at the Continuum Cancer Centers-Beth Israel Medical Center and St. Luke's Roosevelt Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were counseled to exercise at least 18 metabolic equivalent units weekly. Subjects were provided with information on the metabolic equivalents of common forms of exercise.

Reporting Groups
  Description
Single Arm, Life Style Counseling Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.

Participant Flow:   Overall Study
    Single Arm, Life Style Counseling  
STARTED     50  
COMPLETED     34  
NOT COMPLETED     16  
Lost to Follow-up                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Arm, Life Style Counseling Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.

Baseline Measures
    Single Arm, Life Style Counseling  
Number of Participants  
[units: participants]
  50  
Age, Customized  
[units: participants]
 
Age greater than 18 years     50  
Gender, Customized  
[units: participants]
 
Female     21  
Male     26  
Unknown     3  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures

1.  Primary:   Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater   [ Time Frame: 6 months ]

2.  Secondary:   Disease-free Survival   [ Time Frame: after 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Recurrence-free Survival   [ Time Frame: after 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: after 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Many participants were lost to follow-up. Some participants had not been followed for at least 6 months at study termination.  


Results Point of Contact:  
Name/Title: Victoria Rosenwald
Organization: Beth Israel Cancer Center
phone: 212 844-8285
e-mail: vrosenwa@chpnet.org


No publications provided


Responsible Party: Peter Kozuch, MD, Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00977613     History of Changes
Other Study ID Numbers: 003-07
Study First Received: September 15, 2009
Results First Received: November 30, 2010
Last Updated: March 1, 2011
Health Authority: United States: Institutional Review Board