Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Phase 1

Terminated

• Conditions: Endometrial Cancer
• Interventions: Behavioral: 150 weekly minutes walking; Behavioral: 75 weekly minutes walking; Behavioral: Stretching/Flexibility exercise

• Registration Number: NCT01401829
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.

Detailed Description

Endometrial cancer is the most prevalent gynecologic cancer in women. Because of its excellent 5 year survival rate of 83%, addressing longer term cancer effects in this group is an important aspect of cancer survivor care. Unfortunately, women with a history of endometrial cancer may report persistent levels of fatigue, depression, and anxiety that are, on average, higher than those of healthy, gynecologic out-patients. Physical activity is one potential approach to reducing these symptoms, but little is known about the effects of physical activity in endometrial cancer survivors specifically. Furthermore, current evidence is insufficient to make recommendations regarding the optimal exercise amount, type, and duration for improving fatigue, depression, or anxiety after a cancer diagnosis (any cancer type).

This pilot, randomized trial is unique in its focus on endometrial cancer survivors, a previously understudied population with a large potential for benefiting from regular physical activity. Two separate walking intervention groups will work with an exercise specialist three times a week to walk for either 75 minutes (group 1) or 150 minutes (group 2) weekly. The participants will start out slowly and then gradually increase to the particular group goal of 75 or 150 minutes. The stretching exercise group will work with an exercise specialist doing stretching/flexibility exercises three times a week starting with 15 seconds and then gradually increasing to 30 seconds of holding the stretch.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• 1. Female, 18 to 70 years of age with history of Stage I, II, or III endometrial cancer diagnosis occurring at least 6 months prior to study enrollment,
• 2. if chemotherapy or radiation therapy was received, patient must be ≥ 4 weeks post final primary treatment administration,
• 3. if patient has undergone surgical procedure, must be ≥ 8 weeks post-procedure or cleared by surgeon for moderate intensity walking,
• 4. English speaking,
• 5. medical clearance for participation provided by primary care physician or oncologist,
• 6. average fatigue over the past week of ≥3 on a 1 to 10 Likert scale or worrying thoughts ≥ a lot of the time or enjoy the things they used to a little/ not at all.

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Exclusion Criteria

• 1. metastatic or recurrent endometrial cancer,
• 2. inability to ambulate without assistance,
• 3. unstable angina,
• 4. New York Heart Association class II, III, or IV congestive heart failure,
• 5. uncontrolled asthma,
• 6. having been told by a physician to only do exercise prescribed by a physician,
• 7. dementia or organic brain syndrome,
• 8. schizophrenia or active psychosis,
• 9. participating, on average, in more than 20 minutes of physical activity on two or more days per week during the past six months,
• 10. anticipates undergoing elective surgery during the duration of the intervention which would interfere with the intervention participation,
• 11. does not live or work less than 50 miles from the study site,
• 12. lack of transportation to the study site,
• 13. plans to move residence out of the local area during the study duration,
• 14. plans to travel out of the local area for more than a week during the intervention,
• 15. contraindication to participation in physical activity,
• 16. non-compliant with sleep apnea treatments.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150 weekly minutes walking	150 weekly minutes walking	12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week
75 weekly minutes walking	75 weekly minutes walking	12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week
Stretching and Flexibility exercise	Stretching/Flexibility exercise	Stretching/Flexibility exercise

Primary Outcome Measures

Name	Time	Method
fatigue	Change from baseline at 12 weeks	13-item multi-dimensional fatigue scale \[i.e. Fatigue Symptom Inventory (FACT-F)\]

Secondary Outcome Measures

Name	Time	Method
Depression and Anxiety	Change in baseline at 12 weeks	14 item Hospital Anxiety and Depression Scale (PROMIS)
Task self-efficacy	Change in baseline at 12 weeks	4 item scale for chronic disease patients
Quality of Life	Change in baseline at 12 weeks	Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Body Mass Index (BMI)	Change in baseline at 12 weeks	BMI calculated with weight and height
Body Composition	Change in baseline at 12 weeks	Bioelectrical Impedance
Waist and Hip circumferences	Change in baseline at 12 weeks	the average of three measures of waist and hip (each) using a tape measure
fitness	Change in baseline at 12 weeks	submaximal fitness test
muscle strength	Change in baseline at 12 weeks	back/leg dynamometer and hand grip dynamometer
feasibility	one year	Number of patients recruited, Number of patients who complete the walking intervention, Number of adverse events reported, and Number of patients who complete the study
demographic, lifestyle, and medical covariates	one year	self-administered survey

Trial Locations

Locations (1)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States