To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
12 week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
12 week stretching intervention group with a goal of 3 sessions per week while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
Southern Illinois University School of Medicine
Springfield, Illinois, United States
fatigue
13-item multi-dimensional fatigue scale \[i.e. Fatigue Symptom Inventory (FACT-F)\]
Time frame: Change from baseline at 12 weeks
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Time frame: Change from baseline at 8 weeks
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Time frame: Change in baseline at 12 weeks
Task self-efficacy
4 item scale for chronic disease patients
Time frame: Change in baseline at 8 weeks
Task self-efficacy
4 item scale for chronic disease patients
Time frame: Change in baseline at 12 weeks
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Time frame: Change in baseline at 8 weeks
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Time frame: Change in baseline at 12 weeks
Body Mass Index (BMI)
BMI calculated with weight and height
Time frame: Change in baseline at 8 weeks
Body Mass Index (BMI)
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BMI calculated with weight and height
Time frame: Change in baseline at 12 weeks
Body Composition
Bioelectrical Impedance
Time frame: Change in baseline at 8 weeks
Body Composition
Bioelectrical Impedance
Time frame: Change in baseline at 12 weeks
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
Time frame: Change in baseline at 8 weeks
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
Time frame: Change in baseline at 12 weeks
fitness
submaximal fitness test
Time frame: Change in baseline at 8 weeks
fitness
submaximal fitness test
Time frame: Change in baseline at 12 weeks
muscle strength
back/leg dynamometer and hand grip dynamometer
Time frame: Change in baseline at 8 weeks
muscle strength
back/leg dynamometer and hand grip dynamometer
Time frame: Change in baseline at 12 weeks
feasibility
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
Time frame: one year
demographic, lifestyle, and medical covariates
self-administered survey
Time frame: one year