Physical Activity, Fatigue, Sleep, and Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

Detailed Description
-----------------
Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention. Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels. Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands. This randomized controlled trial includes the following study aims: Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention. Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

Official Title
-----------------
Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: 3 month physical activity intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure. English speaking Medical clearance for participation provided by primary care physician or oncologist Postmenopausal Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months Willing to abstain from as needed medications for 7 days prior to each blood draw. As needed medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily). Exclusion Criteria: Metastatic or recurrent breast cancer Inability to ambulate without assistance Unstable angina New York Heart Association class II, III, or IV congestive heart failure Uncontrolled asthma Interstitial lung disease Current use of steroids Having been told by a physician to only do exercise prescribed by a physician Dementia or organic brain syndrome Schizophrenia or active psychosis Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis] Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery). Do not live or work less than 50 miles from the study site Lack of transportation to the study site Changes in usual medications expected during the study time period Plan to move residence out of the local area during the 5 months of the study Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>no physical activity intervention | |
| Experimental: Exercise intervention<br>3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands | Behavioral: 3 month physical activity intervention<br>* 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands<br>* Other names: exercise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention. | baseline and 3 months | 
| muscle strength | The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention. | baseline and 3 months | 
| fatigue | The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention. | baseline and 3 months | 
| sleep dysfunction | The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory markers (serum cytokine levels) | The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected. | baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, breast cancer, physical activity, fatigue, sleep dysfunction, cytokines, muscle strength, inflammation