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Physical Activity After Endometrial Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2009
First Received: July 12, 2007   Last Updated: November 18, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Institutes of Health (NIH)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501761
  Purpose

The investigators 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:

  • 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.
  • To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
  • To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
  • 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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Physical activity adoption and adherence in endometrial cancer survivors [ Time Frame: Assessments will take place every 2 months, for 4 assessments over a 6-month period. ] [ 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

  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

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

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Karen Basen-Engquist, PhD/Professor )
Study ID Numbers: 2004-0454
Study First Received: July 12, 2007
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00501761     History of Changes
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

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010