Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

May 11, 2015 updated by: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROG-SIU-11-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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