Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01504789 |
| Other study ID # |
2011-0201 |
| Secondary ID |
U54NCI-2015-0175 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 7, 2012 |
| Est. completion date |
February 28, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this research study is to test an exercise program that is designed for Hispanic
breast cancer survivors. Researchers want to learn the most effective strategies for
promoting exercise.
Description:
Study Summary:
If you are found to be eligible to take part in this study, you will come in for 2 visits to
complete fitness testing and questionnaires at the Behavioral Research Treatment Center
(BRTC) at MD Anderson. During the week before your first visit to the BRTC, you'll wear an
accelerometer at home. An accelerometer is a small device that you wear on your waist during
the day. It records how active you are. The accelerometer will be mailed to you or given to
you in clinic ahead of time by a staff member. You will bring the accelerometer with you to
your first visit to the BRTC. This will be repeated at the end before your follow-up
assessment visit. The visits should last about 2 hours and 30 minutes. You will be asked to
exercise about 3-5 times every week for 16 weeks at home for at least 30 minutes. You will
also be invited to group exercise sessions every month. You should attend at least 2 of these
sessions. A family member or friend is invited to attend the group sessions with you. Six (3)
months after the follow-up visit, you will complete follow-up questionnaires.
Study Visits:
At the baseline (first) visit, your blood pressure, heart rate, height, and weight will be
measured. Your waist and hip will be measured. A tool that measures your skin thickness will
be used on the back of your arm, above your hip, and on your thigh. Your arms will be
measured by placing your arm in a tool used for measuring arm volume.
You will complete questionnaires about your demographic information (such as your age),
medical history, any drugs you may be taking, your current level of physical activity, your
quality of life, and your environment and exercise (such as how many people you see
exercising daily). The questionnaires should take about 35 minutes to complete. You may
complete these questionnaires either when you sign the informed consent form or at your first
visit.
Blood (about 1½ tablespoons) will be drawn during your baseline and 4-months visits after you
fast (have nothing to eat or drink but water) for 12 hour. These samples will be stored for
future testing on biomarkers. Biomarkers are found in the blood and may be related to breast
cancer risk.
You will complete fitness tests to measure your strength, flexibility, balance, and aerobic
capacity (how effectively you breathe in air while you are exercising).
For the strength tests, you will pull on a bar that is connected to a sensor that shows how
much force you are using. You will pull on the bar as hard as you can for 3 seconds. You will
have at least 10 seconds of rest between efforts. You will do pulls to measure the strength
of your arms, shoulders, and upper body. To measure your hand and forearm muscle strength,
you will squeeze and release your hand on a hand tool. To measure your leg strength, you will
stand and sit back down in a chair as many times as you can in 30 seconds. You will be shown
how to do each of these tests.
For flexibility, you will perform a "sit-and-reach" test and a "stand-and-reach" test. Your
hip and lower back flexibility will be measured using a "sit-and-reach" flexibility box. You
will sit on the floor with your feet placed on the edge of the box. You will reach forward
with your hands as far as possible 3 different times. The farthest reach will measure your
lower body flexibility. To measure your upper body flexibility, you will do a "stand and
reach" test. You will stand next to a wall with your arm stretched forward. Then you will
reach forward as far as possible without your feet lifting off the ground. The distance
reached forward will be the measure of your upper body flexibility. Range of motion of your
arm will be measured by asking you to lift your arm upward with your thumb pointing up. This
will be done on the side and in front of you.
For aerobic testing, you will be asked to walk on a treadmill. Before you exercise, you will
have an electrocardiogram (ECG) to check your heart function and your heart rate and blood
pressure will be measured. A nose clip and mouthpiece will be put on you. During exercising,
you will have an ECG. Your blood pressure will also be measured every few minutes. You will
be asked at several times to point to a scale that measures your overall level of effort. You
will walk on the treadmill at increasing speeds and inclines (hills) until you reach a point
of about 85 percent of your maximum heart rate. At that point, the treadmill will be slowed
down and you will be allowed to walk slowly and recover. You can ask to stop the treadmill at
any time. The reason for doing this test is to see how your body reacts to hard exercise at
an intensity higher than will be recommended for you during the study when you will be
exercising on your own. You will be asked to perform a 6-minute walk test as a warm-up. This
test measures the distance that you can walk quickly on a flat, hard surface for 6 minutes.
All of the baseline fitness tests will be repeated at the end of the program (at about the
16th week) during a follow-up visit. At the follow-up visit, you will also be asked to
complete a feedback questionnaire and you will be interviewed for your feedback on the
newsletters. This will help researchers design future research studies. The questionnaire and
interview should take about 15 minutes to complete. You will also be asked to answer a Food
Questionnaire at the follow-up visit. This questionnaire will include questions about your
usual food intake during the last year. It will take about an hour to complete this
questionnaire.
Study Groups:
After your baseline fitness tests and questionnaires, you will be randomly assigned (as in
the flip of a coin) to 1 of 3 study groups. Groups 1 and 2 will be given an individualized
exercise program, have the same amount of contact with research staff, and receive written
materials about exercise. The only difference between the groups is that they will be given
different written materials. Group 3 will be a "waiting list" group who choose to participate
in the exercise program after their 16-week assessment. After 4 months of exercise, they will
repeat all the follow-up tests described above, and receive an exercise recommendation and
all the intervention materials. You will have an equal chance of being assigned to one of the
three groups. You will know if you are in the waiting list group (3) or one of the exercise
groups (1 or 2), but if you are in an exercise group you will not know which one.
Exercise Program:
Based on the results of the fitness tests, a specific exercise program for you will be
presented to you. The comprehensive program will include aerobic (cardiovascular) training,
strength training, and flexibility training to be completed at home. A set of resistance
tubes will be given to you to keep and use at home. You will also be given a booklet and DVD
video that contain the exercise. If you would like, after the follow-up visit, a long-term
suggested exercise program will be given to you.
You will be given an exercise log to keep track of your exercising. You will also be asked to
fill out a questionnaire every week that asks about your level of physical activity. The
questionnaire should take about 5 minutes to complete. Every month, you will be asked to fill
out a questionnaire about any swelling you may have had. This questionnaire should take about
5 minutes to complete. Every month, you will mail your completed questionnaires and exercise
logs back to the study staff in postage-paid envelopes that will be provided to you.
Newsletters and Study Contact:
Every 2 weeks, you will receive a newsletter on a different theme related to exercise. One of
the newsletters will be about healthy eating. The wording of the material will be different
between groups, but the overall theme will be the same. The research staff will call you
about every 2 weeks to check that you have received the materials and have sent back whatever
materials are due. The phone call should take no more than 15 minutes. However, you can ask
research staff any questions about the program at any time using the contact information that
will be given to you.
Follow-up Questionnaires:
At 3 months after the follow-up visit, a packet of follow-up questionnaires about your
physical activity and quality of life will be mailed to you or given over the phone. The
questionnaire packet will be mailed with a postage-paid return envelope. It should take about
10 minutes to complete the questionnaires. The research staff will call you to check that you
have received it and encourage you to complete it. If you are coming to MD Anderson for any
appointments, you will receive the packet in person instead.
Length of Study:
Your study participation will be over after you complete the follow-up questionnaires. Your
study participation may be stopped early if you become injured, if you become ineligible (for
example, if you need to have treatment), or if the research staff thinks it is in your best
interest.
