MDACC Study Summary 2004-0454

Study Summary
No. 2004-0454:.......Endometrial......Karen Basen-Engquist......Behavioral Science

Study Summary Title



Study Summary Number:	2004-0454

Study Title:	Social Cognitive Theory and Physical Activity after Endometrial Cancer

Physician

New Patient Referral



Name:	Karen Basen-Engquist	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3123 Contact us about clinical trials

General Information



Disease Group:	Endometrial	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants must attend an initial orientation and return to MDACC on 4 occasions for lab assessments. Pilot study participants must attend an orientation session and return a second time for lab assessments.

Treatment Agents:	None	Home Care:	Participants will be asked to participate in phone counseling and to follow an exercise program at home as part of the study.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No stay is required


Description/ Intervention:	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.

Study Objectives / Outcomes

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

Study Status Information



Study Activation / Registration Date:	05/10/2005

IRB Review and Approval Date:	07/21/2004

Study Type:

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00501761
Study Information on Clinical Trials Registry (clinicaltrials.gov)