Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373022
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2006-09-06
Brief Title:
Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Physical activity may prevent or lessen depression and anxiety and improve quality of life and immune function in patients with colorectal cancer
PURPOSE This randomized clinical trial is studying how well physical activity helps patients with stage II or stage III colorectal cancer recover from cancer
PURPOSE This randomized clinical trial is studying how well physical activity helps patients with stage II or stage III colorectal cancer recover from cancer
Detailed Description:
OBJECTIVES
Primary
Assess the effect of moderate physical activity interventions in ameliorating quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire in patients undergoing or who have previously received chemotherapy for stage II or III colorectal cancer
Secondary
Assess the effect of different moderate physical activity interventions in ameliorating depression as measured by the Beck Depression Inventory and anxiety as measured by the Spielberger State-Trait Anxiety Inventory in these patients
Assess the effect of these interventions on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire in these patients
Characterize serum levels and patterns of immune function cytokines neutrophils T cells B cells natural killer NK cells and immunoglobulin in these patients
Correlate serum levels and patterns of immune function cytokines neutrophils T cells B cells NK cells and immunoglobulin with the patients physical activity levels
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients participate in individual walking sessions once a week for 8 weeks The sessions include a fitness-related discussion warm-up and stretch 45 minutes of physical activity consisting of walking progressing in intensity and a cool-down period
Arm II Patients participate in a group walking sessions once a week for 8 weeks The sessions include a fitness-related discussion warm-up and stretch 45 minutes of physical activity consisting of walking progressing in intensity as in arm I and a cool-down period
Arm III Patients participate in self-directed physical activity sessions 1½ hours once a week for 8 weeks The sessions include warm-up and stretch followed by 45 minutes of progressively intensified physical activity that integrates fundamentals of movement dance and exercise principles from established movement methods ie yoga and a relaxation sessioncool-down period
All patients complete self-reported questionnaires Spielberger State-Trait Anxiety Inventory Beck Depression Inventory Functional Assessment of Cancer Therapy-Colon and American Council on Exercise History questionnaires Patients also undergo blood collection at baseline at 4 weeks upon completion of study treatment and at 4 months after completion of study treatment for correlative studies Blood is examined by flow cytometry for immune function and cytokines
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
Primary
Assess the effect of moderate physical activity interventions in ameliorating quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire in patients undergoing or who have previously received chemotherapy for stage II or III colorectal cancer
Secondary
Assess the effect of different moderate physical activity interventions in ameliorating depression as measured by the Beck Depression Inventory and anxiety as measured by the Spielberger State-Trait Anxiety Inventory in these patients
Assess the effect of these interventions on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire in these patients
Characterize serum levels and patterns of immune function cytokines neutrophils T cells B cells natural killer NK cells and immunoglobulin in these patients
Correlate serum levels and patterns of immune function cytokines neutrophils T cells B cells NK cells and immunoglobulin with the patients physical activity levels
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients participate in individual walking sessions once a week for 8 weeks The sessions include a fitness-related discussion warm-up and stretch 45 minutes of physical activity consisting of walking progressing in intensity and a cool-down period
Arm II Patients participate in a group walking sessions once a week for 8 weeks The sessions include a fitness-related discussion warm-up and stretch 45 minutes of physical activity consisting of walking progressing in intensity as in arm I and a cool-down period
Arm III Patients participate in self-directed physical activity sessions 1½ hours once a week for 8 weeks The sessions include warm-up and stretch followed by 45 minutes of progressively intensified physical activity that integrates fundamentals of movement dance and exercise principles from established movement methods ie yoga and a relaxation sessioncool-down period
All patients complete self-reported questionnaires Spielberger State-Trait Anxiety Inventory Beck Depression Inventory Functional Assessment of Cancer Therapy-Colon and American Council on Exercise History questionnaires Patients also undergo blood collection at baseline at 4 weeks upon completion of study treatment and at 4 months after completion of study treatment for correlative studies Blood is examined by flow cytometry for immune function and cytokines
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA023074 | NIH | None | None |
| UARIZ-A0404 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |