Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
CICK
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Mar 2008
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 13, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 12, 2015
May 1, 2015
5 years
March 13, 2008
May 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pro-inflammatory and anti-inflammatory cytokines
baseline and 3 months
Secondary Outcomes (1)
Change in fatigue, sleep and muscle strength
baseline and 3 months
Study Arms (2)
Physical activity intervention
EXPERIMENTALBehavior change intervention
Standard of care with written materials
NO INTERVENTIONWritten materials
Interventions
Multidisciplinary
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9636, United States
Related Publications (4)
Rogers LQ, Markwell SJ, Courneya KS, McAuley E, Verhulst S. Physical activity type and intensity among rural breast cancer survivors: patterns and associations with fatigue and depressive symptoms. J Cancer Surviv. 2011 Mar;5(1):54-61. doi: 10.1007/s11764-010-0160-8. Epub 2010 Nov 26.
PMID: 21110134BACKGROUNDRogers LQ, Vicari S, Courneya KS. Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Cancer Nurs. 2010 Nov-Dec;33(6):E10-7. doi: 10.1097/NCC.0b013e3181db699d.
PMID: 20562618BACKGROUNDRogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
PMID: 19383889BACKGROUNDRogers LQ, Fogleman A, Trammell R, Hopkins-Price P, Vicari S, Rao K, Edson B, Verhulst S, Courneya KS, Hoelzer K. Effects of a physical activity behavior change intervention on inflammation and related health outcomes in breast cancer survivors: pilot randomized trial. Integr Cancer Ther. 2013 Jul;12(4):323-35. doi: 10.1177/1534735412449687. Epub 2012 Jul 24.
PMID: 22831916RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Q Rogers, M.D., M.P.H.
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 13, 2008
First Posted
March 21, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2013
Study Completion
March 1, 2015
Last Updated
May 12, 2015
Record last verified: 2015-05