Back to resultsPsychosocial Benefits of Exercise in Endometrial Cancer Survivors
Primary Purpose
Endometrial Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
150 weekly minutes walking
75 weekly minutes walking
Stretching/Flexibility exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Endometrial Cancer focused on measuring endometrial cancer, aerobic walking, stretching/flexibility exercises, quality of life
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.
Sites / Locations
- Southern Illinois University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
75 weekly minutes walking
150 weekly minutes walking
Stretching and Flexibility exercise
Arm Description
12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week
12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week
Stretching/Flexibility exercise
Outcomes
Primary Outcome Measures
fatigue
13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]
Secondary Outcome Measures
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Depression and Anxiety
14 item Hospital Anxiety and Depression Scale (PROMIS)
Task self-efficacy
4 item scale for chronic disease patients
Task self-efficacy
4 item scale for chronic disease patients
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Quality of Life
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Body Mass Index (BMI)
BMI calculated with weight and height
Body Mass Index (BMI)
BMI calculated with weight and height
Body Composition
Bioelectrical Impedance
Body Composition
Bioelectrical Impedance
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
Waist and Hip circumferences
the average of three measures of waist and hip (each) using a tape measure
fitness
submaximal fitness test
fitness
submaximal fitness test
muscle strength
back/leg dynamometer and hand grip dynamometer
muscle strength
back/leg dynamometer and hand grip dynamometer
feasibility
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
self-administered survey
Full Information
NCT ID
NCT01401829
First Posted
July 21, 2011
Last Updated
May 11, 2015
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01401829
Brief Title
Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
Official Title
Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of funding required to continue the study.
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, aerobic walking, stretching/flexibility exercises, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
75 weekly minutes walking
Arm Type
Experimental
Arm Description
12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week
Arm Title
150 weekly minutes walking
Arm Type
Experimental
Arm Description
12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week
Arm Title
Stretching and Flexibility exercise
Arm Type
Active Comparator
Arm Description
Stretching/Flexibility exercise
Intervention Type
Behavioral
Intervention Name(s)
150 weekly minutes walking
Other Intervention Name(s)
moderate intensity aerobic walking
Intervention Description
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
Intervention Name(s)
75 weekly minutes walking
Other Intervention Name(s)
moderate intensity aerobic walking
Intervention Description
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
Intervention Name(s)
Stretching/Flexibility exercise
Other Intervention Name(s)
stretching exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
fatigue
Description
13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]
Time Frame
Change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Depression and Anxiety
Description
14 item Hospital Anxiety and Depression Scale (PROMIS)
Time Frame
Change from baseline at 8 weeks
Title
Depression and Anxiety
Description
14 item Hospital Anxiety and Depression Scale (PROMIS)
Time Frame
Change in baseline at 12 weeks
Title
Task self-efficacy
Description
4 item scale for chronic disease patients
Time Frame
Change in baseline at 8 weeks
Title
Task self-efficacy
Description
4 item scale for chronic disease patients
Time Frame
Change in baseline at 12 weeks
Title
Quality of Life
Description
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Time Frame
Change in baseline at 8 weeks
Title
Quality of Life
Description
Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale
Time Frame
Change in baseline at 12 weeks
Title
Body Mass Index (BMI)
Description
BMI calculated with weight and height
Time Frame
Change in baseline at 8 weeks
Title
Body Mass Index (BMI)
Description
BMI calculated with weight and height
Time Frame
Change in baseline at 12 weeks
Title
Body Composition
Description
Bioelectrical Impedance
Time Frame
Change in baseline at 8 weeks
Title
Body Composition
Description
Bioelectrical Impedance
Time Frame
Change in baseline at 12 weeks
Title
Waist and Hip circumferences
Description
the average of three measures of waist and hip (each) using a tape measure
Time Frame
Change in baseline at 8 weeks
Title
Waist and Hip circumferences
Description
the average of three measures of waist and hip (each) using a tape measure
Time Frame
Change in baseline at 12 weeks
Title
fitness
Description
submaximal fitness test
Time Frame
Change in baseline at 8 weeks
Title
fitness
Description
submaximal fitness test
Time Frame
Change in baseline at 12 weeks
Title
muscle strength
Description
back/leg dynamometer and hand grip dynamometer
Time Frame
Change in baseline at 8 weeks
Title
muscle strength
Description
back/leg dynamometer and hand grip dynamometer
Time Frame
Change in baseline at 12 weeks
Title
feasibility
Description
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
Time Frame
one year
Title
demographic, lifestyle, and medical covariates
Description
self-administered survey
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Q. Rogers, MD, MPH
Organizational Affiliation
Southern Illinois University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21603254
Citation
Rogers LQ. Objective monitoring of physical activity after a cancer diagnosis: challenges and opportunities for enhancing cancer control. Phys Ther Rev. 2010 Jun 1;15(3):224-237. doi: 10.1179/174328810X12814016178872.
Results Reference
background
PubMed Identifier
21558582
Citation
Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.
Results Reference
background
PubMed Identifier
19383889
Citation
Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
Results Reference
background
PubMed Identifier
19340875
Citation
Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.
Results Reference
background
PubMed Identifier
18642320
Citation
Rogers LQ, Courneya KS, Robbins KT, Rao K, Malone J, Seiz A, Reminger S, Markwell SJ, Burra V. Factors associated with fatigue, sleep, and cognitive function among patients with head and neck cancer. Head Neck. 2008 Oct;30(10):1310-7. doi: 10.1002/hed.20873.
Results Reference
background
PubMed Identifier
19780920
Citation
Rogers LQ, Markwell SJ, Courneya KS, McAuley E, Verhulst S. Exercise preference patterns, resources, and environment among rural breast cancer survivors. J Rural Health. 2009 Fall;25(4):388-91. doi: 10.1111/j.1748-0361.2009.00249.x.
Results Reference
background
Links:
URL
http://www.acsm.org/
Description
American College of Sports Medicine
URL
http://www.cancer.gov/
Description
National Cancer Institute of the National Institutes of Health
Learn more about this trial
Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
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