Psychosocial Benefits of Exercise in Endometrial Cancer Survivors - Full Text View

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:

MedlinePlus related topics: Anxiety Benign Tumors Cancer Depression Exercise and Physical Fitness Fatigue

U.S. FDA Resources

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

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:

American Cancer Society This link exits the ClinicalTrials.gov site

American College of Sports Medicine This link exits the ClinicalTrials.gov site

National Cancer Institute of the National Institutes of Health This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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. Epub 2009 Apr 21.

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.

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.

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.

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
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on June 18, 2013