Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Endometrial Cancer Clinical Trial

Official title:

Psychosocial Benefits of Exercise in Endometrial Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401829
• Other study ID #: ROG-SIU-11-004
• Status: Terminated
• Phase: Phase 1
• First received: July 21, 2011
• Last updated: May 11, 2015
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)]	Change from baseline at 12 weeks	No
Secondary	Depression and Anxiety	14 item Hospital Anxiety and Depression Scale (PROMIS)	Change from baseline at 8 weeks	No
Secondary	Depression and Anxiety	14 item Hospital Anxiety and Depression Scale (PROMIS)	Change in baseline at 12 weeks	No
Secondary	Task self-efficacy	4 item scale for chronic disease patients	Change in baseline at 8 weeks	No
Secondary	Task self-efficacy	4 item scale for chronic disease patients	Change in baseline at 12 weeks	No
Secondary	Quality of Life	Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale	Change in baseline at 8 weeks	No
Secondary	Quality of Life	Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale	Change in baseline at 12 weeks	No
Secondary	Body Mass Index (BMI)	BMI calculated with weight and height	Change in baseline at 8 weeks	No
Secondary	Body Mass Index (BMI)	BMI calculated with weight and height	Change in baseline at 12 weeks	No
Secondary	Body Composition	Bioelectrical Impedance	Change in baseline at 8 weeks	No
Secondary	Body Composition	Bioelectrical Impedance	Change in baseline at 12 weeks	No
Secondary	Waist and Hip circumferences	the average of three measures of waist and hip (each) using a tape measure	Change in baseline at 8 weeks	No
Secondary	Waist and Hip circumferences	the average of three measures of waist and hip (each) using a tape measure	Change in baseline at 12 weeks	No
Secondary	fitness	submaximal fitness test	Change in baseline at 8 weeks	No
Secondary	fitness	submaximal fitness test	Change in baseline at 12 weeks	No
Secondary	muscle strength	back/leg dynamometer and hand grip dynamometer	Change in baseline at 8 weeks	No
Secondary	muscle strength	back/leg dynamometer and hand grip dynamometer	Change in baseline at 12 weeks	No
Secondary	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	one year	Yes
Secondary	demographic, lifestyle, and medical covariates	self-administered survey	one year	No

External Links

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