Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

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

Detailed Description
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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.

Official Title
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Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Behavioral: 150 weekly minutes walking
* Behavioral: 75 weekly minutes walking
* Behavioral: Stretching/Flexibility exercise


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 75 weekly minutes walking<br>12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week | Behavioral: 75 weekly minutes walking<br>* 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<br>* Other names: moderate intensity aerobic walking;|
| Experimental: 150 weekly minutes walking<br>12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week | Behavioral: 150 weekly minutes walking<br>* 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<br>* Other names: moderate intensity aerobic walking;|
| Active Comparator: Stretching and Flexibility exercise<br>Stretching/Flexibility exercise | Behavioral: Stretching/Flexibility exercise<br>* 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<br>* Other names: stretching exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatigue | 13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)] | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and Anxiety | 14 item Hospital Anxiety and Depression Scale (PROMIS) | Change from baseline at 8 weeks | 
| Depression and Anxiety | 14 item Hospital Anxiety and Depression Scale (PROMIS) | Change in baseline at 12 weeks | 
| Task self-efficacy | 4 item scale for chronic disease patients | Change in baseline at 8 weeks | 
| Task self-efficacy | 4 item scale for chronic disease patients | Change in baseline at 12 weeks | 
| Quality of Life | Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale | Change in baseline at 8 weeks | 
| Quality of Life | Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale | Change in baseline at 12 weeks | 
| Body Mass Index (BMI) | BMI calculated with weight and height | Change in baseline at 8 weeks | 
| Body Mass Index (BMI) | BMI calculated with weight and height | Change in baseline at 12 weeks | 
| Body Composition | Bioelectrical Impedance | Change in baseline at 8 weeks | 
| Body Composition | Bioelectrical Impedance | Change in baseline at 12 weeks | 
| Waist and Hip circumferences | the average of three measures of waist and hip (each) using a tape measure | Change in baseline at 8 weeks | 
| Waist and Hip circumferences | the average of three measures of waist and hip (each) using a tape measure | Change in baseline at 12 weeks | 
| fitness | submaximal fitness test | Change in baseline at 8 weeks | 
| fitness | submaximal fitness test | Change in baseline at 12 weeks | 
| muscle strength | back/leg dynamometer and hand grip dynamometer | Change in baseline at 8 weeks | 
| muscle strength | back/leg dynamometer and hand grip dynamometer | 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 | one year | 
| demographic, lifestyle, and medical covariates | self-administered survey | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, aerobic walking, stretching/flexibility exercises, quality of life