Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

This study has been terminated.
(Terminated due to lack of funding required to continue the study.)
Sponsor:
Information provided by (Responsible Party):
Laura Rogers, MD, MPH, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01401829
First received: July 21, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • fatigue [ Time Frame: Change from baseline at 12 weeks ] [ Designated as safety issue: No ]
    13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]


Secondary Outcome Measures:
  • Depression and Anxiety [ Time Frame: Change from baseline at 8 weeks ] [ Designated as safety issue: No ]
    14 item Hospital Anxiety and Depression Scale (PROMIS)

  • Depression and Anxiety [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    14 item Hospital Anxiety and Depression Scale (PROMIS)

  • Task self-efficacy [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    4 item scale for chronic disease patients

  • Task self-efficacy [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    4 item scale for chronic disease patients

  • Quality of Life [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale

  • Quality of Life [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale

  • Body Mass Index (BMI) [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    BMI calculated with weight and height

  • Body Mass Index (BMI) [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    BMI calculated with weight and height

  • Body Composition [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    Bioelectrical Impedance

  • Body Composition [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    Bioelectrical Impedance

  • Waist and Hip circumferences [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    the average of three measures of waist and hip (each) using a tape measure

  • Waist and Hip circumferences [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    the average of three measures of waist and hip (each) using a tape measure

  • fitness [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    submaximal fitness test

  • fitness [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    submaximal fitness test

  • muscle strength [ Time Frame: Change in baseline at 8 weeks ] [ Designated as safety issue: No ]
    back/leg dynamometer and hand grip dynamometer

  • muscle strength [ Time Frame: Change in baseline at 12 weeks ] [ Designated as safety issue: No ]
    back/leg dynamometer and hand grip dynamometer

  • feasibility [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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

  • demographic, lifestyle, and medical covariates [ Time Frame: one year ] [ Designated as safety issue: No ]
    self-administered survey


Enrollment: 2
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401829

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

Additional Information:
Publications:
Responsible Party: Laura Rogers, MD, MPH, Professor, Southern Illinois University
ClinicalTrials.gov Identifier: NCT01401829     History of Changes
Other Study ID Numbers: ROG-SIU-11-004
Study First Received: July 21, 2011
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University:
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

ClinicalTrials.gov processed this record on September 22, 2014