Colorectal Cancer (CRC)
Conditions
Keywords
Treated Stage 2 and Stage 3 colorectal cancer
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.
Interventions
BEHAVIORALexercise counseling
motivational counseling to exercise a minimum 18 metabolic hours per week
Sponsors
Beth Israel Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Overall Survival | after 6 months |
| Disease-free Survival | after 6 months |
| Recurrence-free Survival | after 6 months |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 16 |
Baseline characteristics
| Characteristic | Single Arm, Life Style Counseling |
|---|---|
| Age, Customized Age greater than 18 years | 50 participants |
| Region of Enrollment United States | 50 participants |
| Sex/Gender, Customized Female | 21 participants |
| Sex/Gender, Customized Male | 26 participants |
| Sex/Gender, Customized Unknown | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm, Life Style Counseling | Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater | 18 participants |
Secondary
Disease-free Survival
Time frame: after 6 months
Secondary
Overall Survival
Time frame: after 6 months
Secondary
Recurrence-free Survival
Time frame: after 6 months