Anxiety DisorderNCT00373022
Moderate Physical Activity in Helping Patients Recover Physically and Emotionally From Stage II Or Stage III Colorectal Cancer
A study testing exercise intervention, flow cytometry and laboratory biomarker analysis in people with Anxiety Disorder and Colorectal Cancer, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Colorectal Cancer, Depression
- What is being tested?
- exercise intervention, flow cytometry and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of stage II-III colorectal cancer meeting 1 of the following criteria:
- Undergoing concurrent chemotherapy
- Completed chemotherapy within the past 2 years
PATIENT CHARACTERISTICS:
- No physical or emotional impairment that would limit study compliance
- No prior or current chronic substance abuse
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer
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.
Read the 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 (i.e., yoga) and a relaxation session/cool-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.
- Conditions
- Anxiety Disorder, Colorectal Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- exercise intervention, flow cytometry, laboratory biomarker analysis, management of therapy complications, psychosocial assessment and care
- Keywords
- depression, anxiety disorder, psychosocial effects of cancer and its treatment, stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Anxiety Disorders, Colorectal Neoplasms, Depression, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
flow cytometryOther
laboratory biomarker analysisOther
management of therapy complicationsProcedure or surgery
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire
Secondary outcomes (4)
Effect of moderate physical activity on depression and anxiety as measured by the Beck Depression Inventory and the Spielberger State-Trait Anxiety Inventory
Effect of moderate physical activity on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire
Serum levels and patterns of immune function as measured by cytokine, neutrophil, T cell, B cell, natural killer (NK) cell, and immunoglobulin levels
Correlation of serum levels and patterns of immune function (cytokine, neutrophil, T cell, B cell, NK cell, and immunoglobulin levels) with physical activity levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ana Maria Lopez, MD, MPH, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373022
- Sponsor's protocol ID
- CDR0000491199
- Other IDs
- P30CA023074, UARIZ-A04.04
- Status last verified
- Dec 2006
- First submitted
- 6 Sep 2006
- Last updated
- 27 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Moderate Physical Activity on the Physical and Emotional Recovery of Patients With a History of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00373022
- Acronym / sponsor ID
- CDR0000491199
- Conditions
- Anxiety Disorder, Colorectal Cancer, Depression, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- depression, anxiety disorder, psychosocial effects of cancer and its treatment, stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., yoga) and a relaxation session/cool-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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise intervention | Behavioural | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
| management of therapy complications | Procedure or surgery | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire
4 secondary outcomes
Effect of moderate physical activity on depression and anxiety as measured by the Beck Depression Inventory and the Spielberger State-Trait Anxiety Inventory
Effect of moderate physical activity on attitudes related to physical activity as measured by the American Council on Exercise History questionnaire
Serum levels and patterns of immune function as measured by cytokine, neutrophil, T cell, B cell, natural killer (NK) cell, and immunoglobulin levels
Correlation of serum levels and patterns of immune function (cytokine, neutrophil, T cell, B cell, NK cell, and immunoglobulin levels) with physical activity levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
Related trials for Anxiety Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Maria Lopez, MD, MPH study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, flow cytometry and laboratory biomarker analysis in people with Anxiety Disorder and Colorectal Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of moderate physical activity on quality of life as measured by the Functional Assessment of Cancer Therapy-Colon questionnaire. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010; AzTrials last refreshed its copy on 7 Nov 2026.