Trial Outcomes & Findings for Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients (NCT NCT00977613)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2011-03-03

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	16

Baseline Characteristics

Adherence to a Recommended Exercise Regimen in Colorectal Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm, Life Style Counseling n=50 Participants 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.
Age, Customized Age greater than 18 years	50 participants n=5 Participants
Sex/Gender, Customized Female	21 participants n=5 Participants
Sex/Gender, Customized Male	26 participants n=5 Participants
Sex/Gender, Customized Unknown	3 participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome measures
Measure	Single Arm, Life Style Counseling n=34 Participants 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.
Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater	18 participants

SECONDARY outcome

Timeframe: after 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: after 6 months

Outcome measures

Outcome data not reported

Adverse Events

Single Arm, Life Style Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Victoria Rosenwald

Beth Israel Cancer Center

Phone: 212 844-8285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place