Physical Activity After Endometrial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501761
First received: July 12, 2007
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Researchers 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.
  5. To test the feasibility of a web-based maintenance intervention for women who have completed the phone counseling portion of the study.

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Saliva samples 5 times per day for 2 consecutive days.


Estimated Enrollment: 326
Study Start Date: May 2005
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1: Endometrial Cancer Survivors 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.
Other Name: Survey
2: Healthy Participants
Healthy participants that have no history of invasive cancer.
Behavioral: Questionnaire
Questionnaires regarding physical activity, exercise, and quality of life.
Other Name: Survey
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).
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501761     History of Changes
Other Study ID Numbers: 2004-0454
Study First Received: July 12, 2007
Last Updated: November 20, 2013
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:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014