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Terminated due to lack of funding required to continue the study.
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To determine if weekly exercise compared to stretching has an effect on fatigue, depression, and anxiety in endometrial cancer survivors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 weekly minutes walking | Experimental | 12-week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week |
|
| 150 weekly minutes walking | Experimental | 12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week |
|
| Stretching and Flexibility exercise | Active Comparator | Stretching/Flexibility exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| fatigue | 13-item multi-dimensional fatigue scale [i.e. Fatigue Symptom Inventory (FACT-F)] | Change from baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression and Anxiety | 14 item Hospital Anxiety and Depression Scale (PROMIS) | Change from baseline at 8 weeks |
| Depression and Anxiety | 14 item Hospital Anxiety and Depression Scale (PROMIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Q. Rogers, MD, MPH | Southern Illinois University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21603254 | Background | 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. | |
| 21558582 | 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. |
| Label | URL |
|---|---|
| American Cancer Society | View source |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
|
| 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 |
|
|
| 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 |
|
|
| Change in baseline at 12 weeks |
| Task self-efficacy | 4 item scale for chronic disease patients | Change in baseline at 8 weeks |
| Task self-efficacy | 4 item scale for chronic disease patients | Change in baseline at 12 weeks |
| Quality of Life | Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale | Change in baseline at 8 weeks |
| Quality of Life | Functional Assessment of Cancer Therapy-Endometrial and the Satisfaction With Life Scale | Change in baseline at 12 weeks |
| Body Mass Index (BMI) | BMI calculated with weight and height | Change in baseline at 8 weeks |
| Body Mass Index (BMI) | BMI calculated with weight and height | Change in baseline at 12 weeks |
| Body Composition | Bioelectrical Impedance | Change in baseline at 8 weeks |
| Body Composition | Bioelectrical Impedance | Change in baseline at 12 weeks |
| Waist and Hip circumferences | the average of three measures of waist and hip (each) using a tape measure | Change in baseline at 8 weeks |
| Waist and Hip circumferences | the average of three measures of waist and hip (each) using a tape measure | Change in baseline at 12 weeks |
| fitness | submaximal fitness test | Change in baseline at 8 weeks |
| fitness | submaximal fitness test | Change in baseline at 12 weeks |
| muscle strength | back/leg dynamometer and hand grip dynamometer | Change in baseline at 8 weeks |
| muscle strength | back/leg dynamometer and hand grip dynamometer | Change in baseline at 12 weeks |
| 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 |
| demographic, lifestyle, and medical covariates | self-administered survey | one year |
| 19383889 | 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. |
| 19340875 | 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. |
| 18642320 | 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. |
| 19780920 | 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. |
| American College of Sports Medicine | View source |
| National Cancer Institute of the National Institutes of Health | View source |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |