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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01CA136859-02S1 | U.S. NIH Grant/Contract | View source | |
| U01CA136859 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
| University of Illinois at Urbana-Champaign | OTHER |
| Southern Illinois University |
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The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.
Physical activity may improve quality of life, the control of comorbid conditions, and weight management while reducing breast cancer recurrence and mortality among breast cancer survivors. Unfortunately, most breast cancer survivors do not engage in regular physical activity. In fact, breast cancer survivors are often less active after a diagnosis and may not return to pre-diagnosis activity levels. Therefore, we conducted a pilot study, "BEAT Cancer", to test a specifically defined physical activity behavior change intervention to increase physical activity for breast cancer survivors. The pilot study showed significant improvement in both physical activity and health outcomes for the study participants after the intervention. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, such as the participants feeling more confident in their ability to exercise. The positive results enhance our potential for testing mechanisms that encourage physical activity behavior change in breast cancer survivors. The current study is a follow-up to confirm program effectiveness at 3 months and to test sustainability of results at 3-12 months. We propose a multi-center, randomized controlled trial enrolling 356 breast cancer survivors with the following study aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: exercise with 2 counseling types | Experimental | Patients will participate in 12 individual exercise sessions with an exercise specialist; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist |
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| 2. Usual Care - written materials | Other | Patients will receive written materials about exercise for cancer survivors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 1: exercise with 2 counseling types | Behavioral | Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist |
| Measure | Description | Time Frame |
|---|---|---|
| change in physical activity | Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). | baseline to 3 months |
| change in physical activity | Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). | 3 mos to 6 months |
| change in physical activity | Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). | 6 months to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in treadmill fitness | Treadmill fitness will be measured by sub-maximal fitness test. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). | baseline, 3 months, 6 months, 12 months |
| change in waist-to-hip ratio |
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure (doubly labeled water) | Doubly labeled water results will be used to determine reliability of accelerometer measures as part of an NCI funded supplement. | baseline, 3 months, and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Q. Rogers, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Illinois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 19276838 | Background | Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b. |
| Label | URL |
|---|---|
| National Cancer Institute site on Physical Activity and Cancer | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
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| Usual Care - written materials | Other | Patients will receive written materials about exercise for cancer survivors |
|
Waist-to-hip ratio will be measured with a tape measure. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). |
| baseline, 3 months, 6 months, 12 months |
| change in 3-day dietary intake | 3-day dietary intake will be measured by questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months). | baseline, 3 months, 6 months, 12 months |
| Champaign |
| Illinois |
| 61801 |
| United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| 19241491 | Background | Rogers LQ, Markwell SJ, Verhulst S, McAuley E, Courneya KS. Rural breast cancer survivors: exercise preferences and their determinants. Psychooncology. 2009 Apr;18(4):412-21. doi: 10.1002/pon.1497. |
| 18820344 | Background | Rogers LQ, Courneya KS, Verhulst S, Markwell SJ, McAuley E. Factors associated with exercise counseling and program preferences among breast cancer survivors. J Phys Act Health. 2008 Sep;5(5):688-705. doi: 10.1123/jpah.5.5.688. |
| 18442339 | Background | Rogers LQ, McAuley E, Courneya KS, Verhulst SJ. Correlates of physical activity self-efficacy among breast cancer survivors. Am J Health Behav. 2008 Nov-Dec;32(6):594-603. doi: 10.5555/ajhb.2008.32.6.594. |
| 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. |
| 21983625 | Background | Rogers LQ, McAuley E, Anton PM, Courneya KS, Vicari S, Hopkins-Price P, Verhulst S, Mocharnuk R, Hoelzer K. Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Contemp Clin Trials. 2012 Jan;33(1):124-37. doi: 10.1016/j.cct.2011.09.004. Epub 2011 Sep 29. |
| 25417174 | Result | Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Vicari SK, Robbs RS, Mocharnuk R, McAuley E. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial. Breast Cancer Res Treat. 2015 Jan;149(1):109-19. doi: 10.1007/s10549-014-3216-z. Epub 2014 Nov 23. |
| 40420153 | Derived | Rogers LQ, Midthune D, Dodd K, Bowles H, McAuley E, Courneya KS, Barrett B, Razis S, Hunter GR, Carter SJ, Carroll RJ, Kipnis V. Accelerometer measurement error in a randomized physical activity intervention trial in breast cancer survivors was nondifferential but attenuated the intervention effect. Int J Behav Nutr Phys Act. 2025 May 26;22(1):59. doi: 10.1186/s12966-025-01760-5. |
| 37120460 | Derived | Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Brown NI, Oster RA, Pekmezi D, Rogers LQ. Breast cancer survivors' exercise preferences change during an exercise intervention are associated with post-intervention physical activity. J Cancer Surviv. 2024 Oct;18(5):1453-1463. doi: 10.1007/s11764-023-01389-y. Epub 2023 Apr 29. |
| 36723801 | Derived | Rogers LQ, Courneya KS, Oster RA, Anton PM, Phillips S, Ehlers DK, McAuley E. Physical activity intervention benefits persist months post-intervention: randomized trial in breast cancer survivors. J Cancer Surviv. 2023 Dec;17(6):1834-1846. doi: 10.1007/s11764-022-01329-2. Epub 2023 Feb 1. |
| 36711885 | Derived | Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Brown NI, Oster RA, Pekmezi D, Rogers LQ. Breast Cancer Survivors' Exercise Preferences Change During an Exercise Intervention and are associated with Post-Intervention Physical Activity. Res Sq [Preprint]. 2023 Jan 20:rs.3.rs-2488848. doi: 10.21203/rs.3.rs-2488848/v1. |
| 36526826 | Derived | Schleicher E, McAuley E, Courneya KS, Anton P, Ehlers DK, Phillips SM, Oster RA, Pekmezi D, Rogers LQ. Moderators of physical activity and quality of life response to a physical activity intervention for breast cancer survivors. Support Care Cancer. 2022 Dec 17;31(1):53. doi: 10.1007/s00520-022-07477-6. |
| 29759953 | Derived | Ainsworth MC, Pekmezi D, Bowles H, Ehlers D, McAuley E, Courneya KS, Rogers LQ. Acceptability of a Mobile Phone App for Measuring Time Use in Breast Cancer Survivors (Life in a Day): Mixed-Methods Study. JMIR Cancer. 2018 May 14;4(1):e9. doi: 10.2196/cancer.8951. |
| 27752993 | Derived | Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Robbs RS, Vicari SK, McAuley E. Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Ann Behav Med. 2017 Apr;51(2):321-326. doi: 10.1007/s12160-016-9840-6. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |