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Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01401829
Recruitment Status : Terminated (Terminated due to lack of funding required to continue the study.)
First Posted : July 25, 2011
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Behavioral: 150 weekly minutes walking Behavioral: 75 weekly minutes walking Behavioral: Stretching/Flexibility exercise Phase 1

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  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
Study Start Date : July 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: stretching exercise




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


Secondary Outcome Measures :
  1. Depression and Anxiety [ Time Frame: Change from baseline at 8 weeks ]
    14 item Hospital Anxiety and Depression Scale (PROMIS)

  2. Depression and Anxiety [ Time Frame: Change in baseline at 12 weeks ]
    14 item Hospital Anxiety and Depression Scale (PROMIS)

  3. Task self-efficacy [ Time Frame: Change in baseline at 8 weeks ]
    4 item scale for chronic disease patients

  4. Task self-efficacy [ Time Frame: Change in baseline at 12 weeks ]
    4 item scale for chronic disease patients

  5. Quality of Life [ Time Frame: Change in baseline at 8 weeks ]
    Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale

  6. Quality of Life [ Time Frame: Change in baseline at 12 weeks ]
    Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale

  7. Body Mass Index (BMI) [ Time Frame: Change in baseline at 8 weeks ]
    BMI calculated with weight and height

  8. Body Mass Index (BMI) [ Time Frame: Change in baseline at 12 weeks ]
    BMI calculated with weight and height

  9. Body Composition [ Time Frame: Change in baseline at 8 weeks ]
    Bioelectrical Impedance

  10. Body Composition [ Time Frame: Change in baseline at 12 weeks ]
    Bioelectrical Impedance

  11. 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

  12. 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

  13. fitness [ Time Frame: Change in baseline at 8 weeks ]
    submaximal fitness test

  14. fitness [ Time Frame: Change in baseline at 12 weeks ]
    submaximal fitness test

  15. muscle strength [ Time Frame: Change in baseline at 8 weeks ]
    back/leg dynamometer and hand grip dynamometer

  16. muscle strength [ Time Frame: Change in baseline at 12 weeks ]
    back/leg dynamometer and hand grip dynamometer

  17. 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

  18. demographic, lifestyle, and medical covariates [ Time Frame: one year ]
    self-administered survey



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401829


Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Laura Q. Rogers, MD, MPH Southern Illinois University School of Medicine

Additional Information:
Publications:

Responsible Party: Laura Q. Rogers, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01401829     History of Changes
Other Study ID Numbers: ROG-SIU-11-004
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham:
endometrial cancer
aerobic walking
stretching/flexibility exercises
quality of life

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female