Clinical trial NCT01401829: Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
Official title: Psychosocial Benefits of Exercise in Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Endometrial Cancer
Keywords: endometrial cancer
aerobic walking
stretching/flexibility exercises
quality of life
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: fatigue
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Depression and Anxiety
timeFrame: Change from baseline at 8 weeks
measure: Depression and Anxiety
timeFrame: Change in baseline at 12 weeks
measure: Task self-efficacy
timeFrame: Change in baseline at 8 weeks
measure: Task self-efficacy
timeFrame: Change in baseline at 12 weeks
measure: Quality of Life
timeFrame: Change in baseline at 8 weeks
measure: Quality of Life
timeFrame: Change in baseline at 12 weeks
measure: Body Mass Index (BMI)
timeFrame: Change in baseline at 8 weeks
measure: Body Mass Index (BMI)
timeFrame: Change in baseline at 12 weeks
measure: Body Composition
timeFrame: Change in baseline at 8 weeks
measure: Body Composition
timeFrame: Change in baseline at 12 weeks
measure: Waist and Hip circumferences
timeFrame: Change in baseline at 8 weeks
measure: Waist and Hip circumferences
timeFrame: Change in baseline at 12 weeks
measure: fitness
timeFrame: Change in baseline at 8 weeks
measure: fitness
timeFrame: Change in baseline at 12 weeks
measure: muscle strength
timeFrame: Change in baseline at 8 weeks
measure: muscle strength
timeFrame: Change in baseline at 12 weeks
measure: feasibility
timeFrame: one year
measure: demographic, lifestyle, and medical covariates
timeFrame: one year
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Laura Q. Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.