Changes in Cancer-related Cytokines After Participation in a Physical Activity Behavior Change Intervention (CICK Study)

NCT ID: NCT00640666

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physical activity intervention

Behavior change intervention

Group Type EXPERIMENTAL

Exercise Behavior Change

Intervention Type BEHAVIORAL

Multidisciplinary

Standard of care with written materials

Written materials

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Behavior Change

Multidisciplinary

Intervention Type BEHAVIORAL

Other Intervention Names

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physical activity exercise

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Laura Q. Rogers, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Q Rogers, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21110134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20562618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19383889 (View on PubMed)

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.

Reference Type RESULT
PMID: 22831916 (View on PubMed)

Related Links

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http://www.cancer.gov/cancertopics/factsheet/physical-activity-qa

National Cancer Institute site on Physical Activity and Cancer

Other Identifiers

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ROG-SIU.003

Identifier Type: -

Identifier Source: org_study_id

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