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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

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Exercise, Biomarkers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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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