Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

• Sponsor: Beth Israel Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00977613
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 25
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Given the apparent effect of 18 metabolic equivalent task-hours of activity/week in improving disease free survival in patients with treated stage 3 colon cancer and the survival benefit of exercise demonstrated in patients with stage II and III colorectal cancer, the primary objective is to evaluate compliance at 6 months with post-treatment recommendations for a minimum of 18 metabolic units of physical activity each week in patients who have completed therapy for stage 2 and stage 3 colorectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer (CRC)	Behavioral: exercise counseling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Official Title: Prospective Evaluation of Adherence to Recommended Activity Regimen in Patients Following Treatment of Stages II and III Colorectal Cancer.
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: life style counseling Treated stage 2 and 3 colorectal cancer patients were counseled to exercise at least to the equivalent of 18 metabolic hours per week and were assessed over 6 months.	Behavioral: exercise counseling; motivational counseling to exercise a minimum 18 metabolic hours per week

Outcome Measures

Primary Outcome Measures

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

   One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.

Secondary Outcome Measures

1. Disease-free Survival [after 6 months]

2. Recurrence-free Survival [after 6 months]

3. Overall Survival [after 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with histological confirmation of stage 2 or stage 3 colorectal cancer.

2. Ability to sign written informed consent.

3. WHO performance status of 2 or better.

4. No evidence of recurrent disease or death prior to second questionnaire.

5. Patients with declining physical activity within 90 days of second physical activity assessment will be excluded.

There are no exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Medical Center - Philipps Ambulatory Care Center	New York	New York	United States	10003
2	St. Luke's Roosevelt Hospital Center	New York	New York	United States	10019

Sponsors and Collaborators

• Beth Israel Medical Center

Investigators

• Principal Investigator: Peter S Kozuch, MD, Beth Israel Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00977613
• Other Study ID Numbers: 003-07
• First Posted: Sep 16, 2009
• Last Update Posted: Mar 3, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Treated Stage 2 and Stage 3 colorectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Single Arm, Life Style Counseling
Arm/Group Description	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.
Period Title: Overall Study
STARTED	50
COMPLETED	34
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	Single Arm, Life Style Counseling
Arm/Group Description	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.
Overall Participants	50
Age, Customized (participants) [Number]
Age greater than 18 years	50 100%
Sex/Gender, Customized (participants) [Number]
Female	21 42%
Male	26 52%
Unknown	3 6%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater
Description	One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

34 of the 50 enrolled subjects had at least 6 months of follow-up. There was no evaluable data for the remaining 16 subjects.

Arm/Group Title	Single Arm, Life Style Counseling
Arm/Group Description	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.
Measure Participants	34
Number [participants]	18 36%

2. Secondary Outcome

Title	Disease-free Survival
Time Frame	after 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Recurrence-free Survival
Time Frame	after 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Overall Survival
Time Frame	after 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Single Arm, Life Style Counseling
Arm/Group Description	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.
All Cause Mortality
	Single Arm, Life Style Counseling
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm, Life Style Counseling
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm, Life Style Counseling
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

Many participants were lost to follow-up. Some participants had not been followed for at least 6 months at study termination.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.