Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Brief Title

Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Official Title

Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

fatigue

Secondary Outcome

 Depression and Anxiety

Condition

Endometrial Cancer

Intervention

150 weekly minutes walking

Study Arms / Comparison Groups

 75 weekly minutes walking

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Behavioral

Estimated Enrollment

Start Date

July 2011

Completion Date

January 2013

Primary Completion Date

January 2013

Eligibility Criteria

        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.

Gender

Female

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Laura Q. Rogers, MD, MPH, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01401829

Organization ID

ROG-SIU-11-004

Responsible Party

Principal Investigator

Study Sponsor

University of Alabama at Birmingham

Study Sponsor

Laura Q. Rogers, MD, MPH, Principal Investigator, Southern Illinois University School of Medicine

Verification Date

May 2015