Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
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Purpose
It is important to confirm health benefits experienced by breast cancer survivors after participation in a physical activity behavior change intervention. One such potential benefit is a reduction in harmful inflammation that might lead to increased symptoms or cancer risk. Because little is known about how physical activity behavior change interventions influence inflammation in breast cancer survivors, the investigators study will measure inflammation with blood markers known as cytokines among breast cancer survivors before and after a physical activity intervention. Such information has the potential to lead to improved physical functioning, reduction in bothersome symptoms (e.g., fatigue), and reduced cancer risk in breast cancer survivors.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Exercise Behavior Change |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study) |
- Change in pro-inflammatory and anti-inflammatory cytokines [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
- Change in fatigue, sleep and muscle strength [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Physical activity intervention
Behavior change intervention
|
Behavioral: Exercise Behavior Change
Multidisciplinary
Other Names:
|
|
No Intervention: Standard of care with written materials
Written materials
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are not currently receiving (and do not plan to receive during the study duration) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
- If the patient has undergone a surgical procedure, must be at least 8 weeks post-procedure.
- English speaking.
- Medical clearance for participation provided by primary care physician or oncologist.
Exclusion Criteria:
- Diagnosis of dementia or organic brain syndrome.
- Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
- Contraindication to participation in a regular physical activity program.
- Metastatic or recurrent disease
- Inability to ambulate
- Engaged in ≥ 60 minutes of vigorous physical activity or ≥ 150 minutes of moderate plus vigorous activity per week during the past month.
- Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
- Participant does not live or work within 50 miles of the study site.
Contacts and Locations| United States, Illinois | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9636 | |
| Principal Investigator: | Laura Q Rogers, M.D., M.P.H. | Southern Illinois University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Laura Rogers, MD, MPH, Professor and Director, Southern Illinois University |
| ClinicalTrials.gov Identifier: | NCT00640666 History of Changes |
| Other Study ID Numbers: | ROG-SIU.003 |
| Study First Received: | March 13, 2008 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Southern Illinois University:
|
Breast cancer Exercise Biomarkers |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013