Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-01-31

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.

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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.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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75 weekly minutes walking

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

Group Type EXPERIMENTAL

75 weekly minutes walking

Intervention Type BEHAVIORAL

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

150 weekly minutes walking

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

Group Type EXPERIMENTAL

150 weekly minutes walking

Intervention Type BEHAVIORAL

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

Stretching and Flexibility exercise

Stretching/Flexibility exercise

Group Type ACTIVE_COMPARATOR

Stretching/Flexibility exercise

Intervention Type BEHAVIORAL

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

Interventions

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150 weekly minutes walking

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

Intervention Type BEHAVIORAL

75 weekly minutes walking

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

Intervention Type BEHAVIORAL

Stretching/Flexibility exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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moderate intensity aerobic walking moderate intensity aerobic walking stretching exercise

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No