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The IMPACT Study:

Inflammatory Responses, Mood and Physical Fitness after Cancer Treatment


What is the purpose of the study?

Cardiovascular fitness often declines during and following cancer treatment. This study addresses how your cardiovascular fitness affects your body’s immune response (certain kinds of white blood cells) in ways that may be related to risks for fatigue (tiredness), negative mood, pain sensitivity, memory, and concentration, which are all particularly relevant for cancer survivors. The researchers will use a typhoid vaccine to stimulate brief changes in your immune response to see how your responses to the vaccine compare with responses to a placebo (saline or salt water). They will also measure certain hormone responses and your heart rate and blood pressure and metabolic rate to see how they respond to the vaccine compared to the placebo. The researchers also want to know if your age and/or feeling blue or depressed may affect your body’s responses to the vaccine.

What does the study involve?
The study involves two screening appointments (2 hours each) and two nonconsecutive 9.5-hour study days.  The first screening visit and the full-day visits will take place at the Clinical Research Center (CRC), a hospital research unit located at the OSU Wexner Medical Center.  The second screening visit will take place at the Davis Heart and Lung Research Institute. 

What do the screening visits involve?
The purpose of the screening visits is to determine whether you are eligible to participate in the full study.  These visits will take place on a weekday from 7:00am to 5:00pm. 

At the first screening visit, you will have a small amount of blood drawn (less than a tablespoon) to test for diabetes and anemia.  You will also complete other activities, such as answering questions regarding your mood, feelings, health behaviors, health, and personality.  After you have completed this appointment, you will be notified about whether you are eligible to continue with the remainder of the study.

The second screening visit involves a brief exercise test (6-12 minutes) in which you will be asked to bike at various speeds and workloads (strength needed to pedal).  The test will help researchers to measure your level of fitness.  We are looking for women with a range of fitness levels; you will not be excluded from the study based on your fitness level. The biking will begin at a level that can be easily accomplished, and will gradually increase depending upon your abilities. The test will be stopped when your heart rate reaches 85% of your age-predicted maximal heart rate, or until you cannot exercise.  An exercise physiologist will supervise your exercise test, and a physician will be available on-site.  It is not desired that you exercise at a level that is abnormally uncomfortable; however, you should exercise as long as is reasonably comfortable. You may stop the test at any time.  If you choose not to participate in the exercise test, you will not be able to participate in the rest of the study. Before participating in the exercise test, you will be asked to get signed consent from your oncologist or primary care physician indicating that you are suitable to participate in the exercise. Click here to access the physician consent.

What do the two 9.5-hour study days involve?
You will be scheduled for two 9 1/2-hour visits to the Clinical Research Center (CRC).  These two visits will be scheduled on a weekday and must take place at least 14 days apart (but can be scheduled 30 days apart if needed).  These visits will include blood draws, saliva samples, body measurements, questionnaires, and interviews.

At the beginning of each of your full-day visits, a catheter (a small, hollow plastic tube) will be inserted into a vein in your arm so that small amounts of blood can be drawn at different times across the visit.  The catheter will be removed at the end of each visit.  You will have a total of 250 ml (1 cup + 1 tablespoon) of blood drawn during each of the 9½ hour visits. 

The nurse will administer an injection into your upper arm that contains either saline (salt water) or a typhoid vaccine. Neither you nor the research staff will know the injection type for the day.  This is because a person’s expectations can sometimes influence the way that she feels throughout the day.  If you are not willing to receive the injections, you will not be able to participate in the study.

During both visits your metabolic response to the vaccine and placebo will be measured 6-8 times. In order to obtain this information, you will lie in a hospital bed with a facemask that either covers your nose and mouth for about 25 minutes the first time, and thereafter 10-20 minutes each time. During these times you will be asked to lie still and breathe normally. 

Who can participate?
You may be eligible for this study if you are a woman who:   

  • Is a stage I-IIIA breast cancer survivors between the ages of 40 to 80
  • Completed breast cancer treatment 1 to 10 years ago (except for longer-term hormonal therapy like tamoxifen and aromatase inhibitors)
  • is post-menopausal

How would I benefit by participating?

  • Free parking for each CRC visit
  • Free breakfast and lunch at full-day CRC visits
  • Detailed report regarding your eating patterns, your average daily intake of different nutrients and recommendations for improving your diet.
  • Results obtained from the exercise test will provide you with information about your physical fitness, cardiorespiratory endurance, and your ability to sustain prolonged exercise related to others in your age group.
  • Free report with information about your muscle and fat composition, bone mineral density and resting metabolic rate, which you can discuss with your doctor.
Will I be paid for participating?
You may be reimbursed up to $600 for your time in the full study.

Who are the investigators?
Our investigators are scientists, oncologists, and physicians at the Ohio State University Colleges of Medicine and Public Health.  Our project is a joint venture of the Institute for Behavioral Medicine Research, the Department of Medicine, the School of Public Health, and the Comprehensive Cancer Center.

Please consider participating!

Our investigators are scientists, oncologists, and physicians at the Ohio State University Colleges of Medicine and Public Health.  Our project is a joint venture of the Institute for Behavioral Medicine Research, the Department of Medicine, the School of Public Health, and the Comprehensive Cancer Center.

Need more info?
Click here to read the consent form (pdf)
Click here to read the HIPAA privacy policy (pdf)

Ready to apply!
In order to determine whether you are eligible to participate in the study, you will need to fill out the online application and complete two screening visits. Please click here to fill out the online screening form.