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Social Cognitive Theory and Physical Activity After Endometrial Cancer

45 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

Social Cognitive Theory and Physical Activity After Endometrial Cancer

Women who have been successfully treated for endometrial cancer will be invited to
participate in the study. After you agree to participate you will be asked questions about
your physical activity to make sure you are eligible. You will only be allowed to
participate in this study if your physician feels it is safe for you to engage in moderate
physical activity, so you will be asked to have him or her complete a form about your health
conditions. Information about you cancer and treatment history will be collected from your
medical records as part of the study.

If you agree to take part in this study, you will come to M. D. Anderson for study visits
twice at the beginning of the study. If needed, the activities for these first 2 visits can
be combined into 1 visit, though it will mean that the single visit will take a little
longer than each of the 2 visits. After the first visit, you will be asked to return after
2, 4, and 6 months. Each visit will take about 2 hours. Three (3) months and 6 months after
the last visit, you will be called to answer questions about your physical activity. It
will take about 10 minutes to answer the questions. In case you cannot be reached by phone,
the questionnaires will be mailed to you. You will be asked to mail the questionnaire back
in with a pre-paid addressed envelope.

At the first visit you will complete questionnaires about your quality of life, medical
conditions, and how physically active you are currently and have been in the past. The
questionnaires will take about 45 minutes to complete. A baseline electrocardiogram (ECG-a
test to measure the electrical activity of the heart) will be performed. If your ECG test
is not normal you will be informed. You will practice using the exercise bicycle that will
be used in the fitness testing at the later visits. You will be asked to provide a saliva
sample by placing a cotton roll in your mouth until it is saturated and then placing it back
in a plastic vial without using your hands. This sample will be for practice and will be

You will also be given an ActiGraph to wear for 5 days. This is a small light device that
you wear on your waist during the day. It records how active you are. You will also be
given a handheld computer that you will use for 5 days to answer questions about physical
activity. The computers are small (about 4-1/2 by 3 inches) and light (about 4 1/2 ounces).
The computer will prompt you to enter information up to 8 times a day. Answering these
questions will take up to 5 minutes. You will be asked to return the Actigraph and the
computer on your second visit.

After 5 days, you will come back to M. D. Anderson for your second study visit. During this
visit, you will be asked to complete questionnaires about physical activity that will take
about 1 hour. You will have an electrocardiogram (ECG--a test to measure the electrical
activity of the heart) performed. You will perform a fitness test, in which you will ride a
stationary bicycle while your heart rate, blood pressure, and respiration (breathing) are
monitored. You will also be asked to complete two tasks on a computer. After the second
visit, you will again use the handheld computer and wear an Actigraph for 5 days. You will
also be given 10 vials with a container bag and instructions on collecting saliva samples.
You will be asked to provide saliva samples 5 times per day for 2 consecutive days.

During your second visit, you will meet with an exercise physiologist, a specially-trained
health care professional who will design a personalized exercise program for you, that will
involve walking (up to 30 minutes) on most days of the week. If walking is difficult or
painful for you, another form of exercise will be substituted. In addition to receiving a
personalized exercise program, you will also receive telephone counseling between your
visits to M. D. Anderson and printed materials. Both will provide information and support
for your exercise program. The telephone counseling calls will take place once a week
during the first 2 months, every other week during Months 3 and 4, and once a month during
Months 5 and 6. The phone counselor will talk to you about your exercise program and how it
is working for you. The telephone calls will take place at a time that is convenient to
you, and will take about 15-20 minutes each time. Some of these telephone counseling calls
may be audiotaped, so that the counselors' supervisors can make sure the counseling is done

During each of the 2-month, 4-month, and 6-month clinic visits (Visits 3, 4, and 5), you
will do another fitness test, and any necessary adjustments to your exercise program will be
made. This means that if the goals for exercise were set too high or too low, how often the
exercise occurs or how long each exercise session lasts will be changed. For example, if
the exercise physiologist first recommended that you walk for 15 minutes a day 5 days a
week, but you report that you can't walk for 15 minutes, the length of the walk may be
reduced. You will also fill out the questionnaires and do the tasks on the computer at these
visits. You will complete a brief (5 minutes) program evaluation. You will also be asked
to answer questions on the handheld computer for 5 days before and after each these visits.
You will also be asked to wear the Actigraph for 5 days before and after each of these
visits. At the last visit, you will also be given 10 vials with a container bag and
instructions on collecting saliva samples. You will be asked to provide saliva samples 5
times per day for 2 consecutive days. The study staff will give you a prepaid mailing
envelopes so you can return the computer, the Actigraph, and the package of vials to them by
mail, after the last 5-day period.

This is an investigational study. Up to 326 participants will be enrolled for this study.
For the pilot phase, which has been completed, 22 endometrial cancer survivors and 37
comparison participants with no history of cancer were enrolled. For the main phase of the
study, for which you are enrolling, up to 267 endometrial cancer survivors will be enrolled.
All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Survivor of endometrial cancer (survivor group only).

2. Was diagnosed with Stage I, II, or IIIa endometrial cancer in the past five years
(survivor group only).

3. Completed surgical or radiation treatment at least 6 months ago (survivor group

4. No history of invasive cancer, except for non-melanoma skin cancer (no cancer history

5. Age 45 years of older (no cancer history group).

6. Female (no cancer history group).

7. Not pregnant by self-report (no cancer history group).

8. Speaks and reads English (all participants).

9. Oriented to person, place, and time (all participants).

10. Has clearance from their physician to engage in moderate physical activity (all

11. For web-based maintenance intervention pilot study, women will be included if they
have completed their third follow-up assessment.

12. For web-based maintenance intervention, women are considered ineligible if they do
not have internet access.

Exclusion Criteria:

1. Engages in programmatic physical activity at moderate or greater intensity on five or
more days per week for 30 minutes or more, or vigorous intensity activity 20 minutes
or more at least 3 days per week, and have maintained this level of activity for six
months or longer.

2. Have any condition defined by the American College of Sports Medicine's as "absolute
contraindications to exercise testing" (a recent significant change in the resting
ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or
acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing
symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled
symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute
myocarditis or pericarditis; suspected or known dissecting aneurysm; acute

3. Have any condition as defined by the American College of Sports Medicine's as
"relative contraindications to exercise testing" (left main coronary stenosis;
moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial
hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract
obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are
exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm;
uncontrolled metabolic disease; chronic infectious disease).

4. Right or left bundle branch block.

5. Baseline ST segment or T wave changes that would make monitoring of the ECG stress
test indeterminate.

6. Uncontrolled asthma

7. Have other medical contraindications as defined by the patient's physician.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Physical activity adoption and adherence in endometrial cancer survivors

Outcome Time Frame:

Assessments will take place every 2 months, for 4 assessments over a 6-month period.

Safety Issue:


Principal Investigator

Karen Basen-Engquist, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Healthy Controls
  • Social Cognitive Theory
  • Behavioral Intervention
  • Physical Activity
  • Exercise Program
  • Questionnaire
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



UT MD Anderson Cancer Center Houston, Texas  77030