Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 1

Conditions: Endometrial Cancer

Treatments: Behavioral: 75 weekly minutes walking; Behavioral: Stretching/Flexibility exercise; Behavioral: 150 weekly minutes walking

Study type: Interventional

Funder types: Other

Identifiers

NCT01401829

ROG-SIU-11-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

75 weekly minutes walking

Experimental group

Description:

12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week

Treatment:

Behavioral: 75 weekly minutes walking

150 weekly minutes walking

Experimental group

Description:

12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week

Treatment:

Behavioral: 150 weekly minutes walking

Stretching and Flexibility exercise

Active Comparator group

Description:

Stretching/Flexibility exercise

Treatment:

Behavioral: Stretching/Flexibility exercise