Physical Activity After Endometrial Cancer

NCT00501761 | Unknown

• 2 other identifiers: 2004-04541R01CA109919-01
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To elucidate the influence on self-efficacy of cardiorespiratory fitness and somatic sensations while engaging in physical activity.
3. 3.To determine whether the received dose of an intervention based on Social Cognitive Theory is related to physical activity adherence.
4. 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. 5.To test the feasibility of a web-based maintenance intervention for women who have completed the phone counseling portion of the study.

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Healthy Controls; Social Cognitive Theory; Behavioral Intervention; Physical Activity; Exercise Program; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Physical activity adoption and adherence in endometrial cancer survivors

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

Study Arms (2)

1: Endometrial Cancer Survivors

Behavioral: Personalized Exercise Program; Behavioral: Questionnaire

2: Healthy Participants

Healthy participants that have no history of invasive cancer.

Behavioral: Questionnaire; Behavioral: Suggested Exercise Program

Interventions

Personalized Exercise Program BEHAVIORAL

Walking up to thirty minutes on most days of the week.

1: Endometrial Cancer Survivors

Questionnaire BEHAVIORAL

Questionnaires regarding physical activity, exercise, and quality of life.

Also known as: Survey

1: Endometrial Cancer Survivors; 2: Healthy Participants

Suggested Exercise Program BEHAVIORAL

Exercise program performed over 7 days.

2: Healthy Participants

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Survivor of endometrial cancer (survivor group only).
• Was diagnosed with Stage I, II, or IIIa endometrial cancer in the past five years (survivor group only).
• Completed surgical or radiation treatment at least 6 months ago (survivor group only).
• No history of invasive cancer, except for non-melanoma skin cancer (no cancer history group).
• Age 45 years of older (no cancer history group).
• Female (no cancer history group).
• Not pregnant by self-report (no cancer history group).
• Speaks and reads English (all participants).
• Oriented to person, place, and time (all participants).
• Has clearance from their physician to engage in moderate physical activity (all participants).
• For web-based maintenance intervention pilot study, women will be included if they have completed their third follow-up assessment.
• For web-based maintenance intervention, women are considered ineligible if they do not have internet access.

You may not qualify if:

• 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.
• 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).
• 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).
• Right or left bundle branch block.
• Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate.
• Uncontrolled asthma
• Have other medical contraindications as defined by the patient's physician.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Robertson MC, Lyons EJ, Song J, Cox-Martin M, Li Y, Green CE, Pinto BM, Carmack CL, Harrison C, Baum G, Basen-Engquist KM. Change in physical activity and quality of life in endometrial cancer survivors receiving a physical activity intervention. Health Qual Life Outcomes. 2019 May 27;17(1):91. doi: 10.1186/s12955-019-1154-5.

  PMID: 31133040 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples 5 times per day for 2 consecutive days.

MeSH Terms

Conditions

Endometrial Neoplasms; Motor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen Basen-Engquist, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: May 1, 2005
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

US (1)