Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

NCT01401829 | Terminated Phase 1

• 1 other identifier: ROG-SIU-11-004
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer

Keywords

endometrial cancer; aerobic walking; stretching/flexibility exercises; quality of life

Outcome Measures

Primary Outcomes (1)

• fatigue

  13-item multi-dimensional fatigue scale \[i.e. Fatigue Symptom Inventory (FACT-F)\]

  Change from baseline at 12 weeks

Secondary Outcomes (18)

• Depression and Anxiety

  Change from baseline at 8 weeks

• Depression and Anxiety

  Change in baseline at 12 weeks

• Task self-efficacy

  Change in baseline at 8 weeks

• Task self-efficacy

  Change in baseline at 12 weeks

• Quality of Life

  Change in baseline at 8 weeks

Study Arms (3)

75 weekly minutes walking

EXPERIMENTAL

12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week

Behavioral: 75 weekly minutes walking

150 weekly minutes walking

EXPERIMENTAL

12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week

Behavioral: 150 weekly minutes walking

Stretching and Flexibility exercise

ACTIVE COMPARATOR

Stretching/Flexibility exercise

Behavioral: Stretching/Flexibility exercise

Interventions

150 weekly minutes walking BEHAVIORAL

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

Also known as: moderate intensity aerobic walking

150 weekly minutes walking

75 weekly minutes walking BEHAVIORAL

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

Also known as: moderate intensity aerobic walking

75 weekly minutes walking

Stretching/Flexibility exercise BEHAVIORAL

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

Also known as: stretching exercise

Stretching and Flexibility exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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,
• \) if chemotherapy or radiation therapy was received, patient must be ≥ 4 weeks post final primary treatment administration,
• \) if patient has undergone surgical procedure, must be ≥ 8 weeks post-procedure or cleared by surgeon for moderate intensity walking,
• \) English speaking,
• \) medical clearance for participation provided by primary care physician or oncologist,
• \) 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.

You may not qualify if:

• \) metastatic or recurrent endometrial cancer,
• \) inability to ambulate without assistance,
• \) unstable angina,
• \) New York Heart Association class II, III, or IV congestive heart failure,
• \) uncontrolled asthma,
• \) having been told by a physician to only do exercise prescribed by a physician,
• \) dementia or organic brain syndrome,
• \) schizophrenia or active psychosis,
• \) participating, on average, in more than 20 minutes of physical activity on two or more days per week during the past six months,
• \) anticipates undergoing elective surgery during the duration of the intervention which would interfere with the intervention participation,
• \) does not live or work less than 50 miles from the study site,
• \) lack of transportation to the study site,
• \) plans to move residence out of the local area during the study duration,
• \) plans to travel out of the local area for more than a week during the intervention,
• \) contraindication to participation in physical activity,

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (6)

• 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.

  PMID: 21603254 BACKGROUND

• 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.

  PMID: 21558582 BACKGROUND

• 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.

  PMID: 19383889 BACKGROUND

• 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.

  PMID: 19340875 BACKGROUND

• 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.

  PMID: 18642320 BACKGROUND

• 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.

  PMID: 19780920 BACKGROUND

Related Links

• American Cancer Society
• American College of Sports Medicine
• National Cancer Institute of the National Institutes of Health

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Q. Rogers, MD, MPH

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)