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Physical Activity After Endometrial Cancer

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, January 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501761
  Purpose

We propose to apply Social Cognitive Theory to improve understanding of the mechanisms of physical activity adherence for endometrial cancer survivors participating in a physical activity intervention.

The specific aims of the study are:

  1. To test a Social Cognitive Theory-based model of physical activity adoption among sedentary endometrial cancer survivors receiving an intervention to increase physical activity. The model includes hypotheses about the effect of self-efficacy and outcome expectations on physical activity adherence, the effects of four sources of efficacy information (mastery experience, verbal persuasion, modeling, and physiological feedback) on self-efficacy and subsequent exercise adherence, and the influence of physical activity outcomes on subsequent self-efficacy, outcome expectations, and physical activity.
  2. To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
  3. To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
  4. To test the effects of adherence to physical activity on endometrial cancer survivors' quality of life and stress as assessed by self-report and salivary cortisol.

Condition Intervention
Endometrial Cancer
Behavioral: Personalized Exercise Program
Behavioral: Questionnaire
Behavioral: Suggested Exercise Program

MedlinePlus related topics:   Cancer    Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Social Cognitive Theory and Physical Activity After Endometrial Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this behavioral research study is to better understand the factors that might affect whether or not survivors of endometrial cancer follow a physical exercise program. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To look at how a group of endometrial cancer survivors and a group of women who have not had cancer respond to test questionnaires and other testing procedures related to physical activity, before using the testing tools and procedures in a larger study. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Saliva samples 5 times per day for 2 consecutive days.


Estimated Enrollment:   287
Study Start Date:   May 2005
Estimated Primary Completion Date:   May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Patients that have survived endometrial cancer.
Behavioral: Personalized Exercise Program
Walking up to thirty minutes on most days of the week.
Behavioral: Questionnaire
Questionnaires regarding physical activity, exercise, and quality of life.
2
Healthy participants that have no history of invasive cancer.
Behavioral: Questionnaire
Questionnaires regarding physical activity, exercise, and quality of life.
Behavioral: Suggested Exercise Program
Exercise program performed over 7 days.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Patients that have survived endometrial cancer and healthy participants that have no history of invasive cancer.


Criteria

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

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 infection).
  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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501761

Contacts
Contact: Karen Basen-Engquist, PhD     713-745-3123    

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Karen Basen-Engquist, PhD            

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Karen Basen-Engquist, PhD     U.T.M.D. Anderson Cancer Center    
  More Information

Responsible Party:   U.T.M.D. Anderson Cancer Center ( Karen Basen-Engquist, PhD/Professor )
Study ID Numbers:   2004-0454
First Received:   July 12, 2007
Last Updated:   January 30, 2008
ClinicalTrials.gov Identifier:   NCT00501761
Health Authority:   United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Endometrial Cancer  
Healthy Controls  
Social Cognitive Theory  
Behavioral Intervention  
Physical Activity
Exercise Program
Questionnaire
Survey

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Healthy

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 20, 2008




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