Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study) (CICK)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Behavior Change
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Exercise, Biomarkers
Eligibility Criteria
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.
Sites / Locations
- Southern Illinois University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical activity intervention
Standard of care with written materials
Arm Description
Behavior change intervention
Written materials
Outcomes
Primary Outcome Measures
Change in pro-inflammatory and anti-inflammatory cytokines
Secondary Outcome Measures
Change in fatigue, sleep and muscle strength
Full Information
NCT ID
NCT00640666
First Posted
March 13, 2008
Last Updated
May 9, 2015
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00640666
Brief Title
Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Acronym
CICK
Official Title
Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Exercise, Biomarkers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
Behavior change intervention
Arm Title
Standard of care with written materials
Arm Type
No Intervention
Arm Description
Written materials
Intervention Type
Behavioral
Intervention Name(s)
Exercise Behavior Change
Other Intervention Name(s)
physical activity, exercise
Intervention Description
Multidisciplinary
Primary Outcome Measure Information:
Title
Change in pro-inflammatory and anti-inflammatory cytokines
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in fatigue, sleep and muscle strength
Time Frame
baseline and 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Q Rogers, M.D., M.P.H.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9636
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21110134
Citation
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.
Results Reference
background
PubMed Identifier
20562618
Citation
Rogers 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.
Results Reference
background
PubMed Identifier
19383889
Citation
Rogers 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.
Results Reference
background
PubMed Identifier
22831916
Citation
Rogers 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.
Results Reference
result
Links:
URL
http://www.cancer.gov/cancertopics/factsheet/physical-activity-qa
Description
National Cancer Institute site on Physical Activity and Cancer
Learn more about this trial
Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)
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