Feasibility of an intervention for men on androgen deprivation therapy: A research protocol
Corresponding Author
Alana Manson MS
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Correspondence Alana Manson, School of Nursing, University of Kansas Medical Center, 3901 Rainbow Boulevard, G040, Kansas City, KS 66160.
Email: [email protected]
Search for more papers by this authorJamie Myers PhD, RN, AOCNS®
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorSandra Billinger PhD, PT, FAHA
Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorJaimie Ward MS
Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorWilliam Parker MD
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorJill Hamilton-Reeves PhD, RD, CSO
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorCarrie Michel MS, RD, CSO
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorSally L. Maliski PhD, RN, FAAN
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorCorresponding Author
Alana Manson MS
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Correspondence Alana Manson, School of Nursing, University of Kansas Medical Center, 3901 Rainbow Boulevard, G040, Kansas City, KS 66160.
Email: [email protected]
Search for more papers by this authorJamie Myers PhD, RN, AOCNS®
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorSandra Billinger PhD, PT, FAHA
Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorJaimie Ward MS
Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorWilliam Parker MD
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorJill Hamilton-Reeves PhD, RD, CSO
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorCarrie Michel MS, RD, CSO
Department of Urology, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorSally L. Maliski PhD, RN, FAAN
School of Nursing, University of Kansas Medical Center, Kansas City, Kansas
Search for more papers by this authorClinicalTrials.gov registration NCT02969577
Abstract
Androgen deprivation therapy (ADT) is a treatment used across the prostate cancer disease spectrum and works by suppressing testicular androgen production to castrate levels. Although ADT can provide survival benefits, it is also associated with increased risk for cardiovascular disease, metabolic syndrome, increased visceral fat mass, dyslipidemia, decreased arterial compliance, and diminished health-related quality of life. The Staying Strong And Healthy protocol is a telephone-delivered intervention led by a nurse coordinator to minimize the increased cardiovascular and metabolic risks associated with ADT. This study will evaluate the feasibility of the protocol and provides the foundation for future behavioral interventions across diverse populations of men on ADT.
CONFLICT OF INTERESTS
The authors declare that there is no conflict of interests that could be perceived as prejudicing the impartiality of the research reported.
REFERENCES
- Alibhai, S. M. H., Breunis, H., Timilshina, N., Naglie, G., Tannock, I., Krahn, M., … Tomlinson, G. (2015). Long-term impact of androgen-deprivation therapy on physical function and quality of life. Cancer, 121(14), 2350–2357. https://doi.org/10.1002/cncr.29355
- American Cancer Society. (2018). Key statistics for prostate cancer. Retrieved from https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
- American College of Sports Medicine, Thompson, W. R., Gordon, N. F., & Pescatello, L. S. (2010). ACSM's guidelines for exercise testing and prescription ( 8th ed.). Philadelphia: Lippincott Williams & Wilkins.
- Baguley, B., Bolam, K., Wright, O., & Skinner, T. (2017). The effect of nutrition therapy and exercise on cancer-related fatigue and quality of life in men with prostate cancer: A systematic review. Nutrients, 9(9), 1003. https://doi.org/10.3390/nu9091003
- Bandura, A. (2004). Health promotion by social cognitive means. Health Education & Behavior: The Official Publication of the Society for Public Health Education, 31(2), 143–164. https://doi.org/10.1177/1090198104263660
- Bhandari, N. R., Kathe, N., Hayes, C., & Payakachat, N. (2018). Reliability and validity of SF-12v2 among adults with self-reported cancer. Research in Social and Administrative Pharmacy, 14(11), 1080–1084. https://doi.org/10.10/16/j.sapharm.2018.01.007
- Bourke, L., Doll, H., Crank, H., Daley, A., Rosario, D., & Saxton, J. M. (2011). Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: A feasibility study. Cancer Epidemiology, Biomarkers & Prevention: A Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology, 20(4), 647–657. https://doi.org/10.1158/1055-9965.EPI-10-1143
- Bourke, L., Gilbert, S., Hooper, R., Steed, L. A., Joshi, M., Catto, J. W. F., … Rosario, D. J. (2014). Lifestyle changes for improving disease-specific quality of life in sedentary men on long-term androgen-deprivation therapy for advanced prostate cancer: A randomised controlled trial. European Urology, 65(5), 865–872. https://doi.org/10.1016/j.eururo.2013.09.040
- Braunstein, L. Z., Chen, M. H., Loffredo, M., Kantoff, P. W., & D'Amico, A. V. (2014). Obesity and the odds of weight gain following androgen deprivation therapy for prostate cancer. Prostate Cancer, 2014, 1–6. https://doi.org/10.1155/2014/230812
10.1155/2014/230812 Google Scholar
- Buffart, L. M., Galvão, D. A., Chinapaw, M. J., Brug, J., Taaffe, D. R., Spry, N., … Newton, R. U. (2014). Mediators of the resistance and aerobic exercise intervention effect on physical and general health in men undergoing androgen deprivation therapy for prostate cancer. Cancer, 120(2), 294–301. https://doi.org/10.1002/cncr.28396
- Carlsson, S., Drevin, L., Loeb, S., Widmark, A., Lissbrant, I. F., Robinson, D., … Fransson, P. (2016). Population-based study of long-term functional outcomes after prostate cancer treatment. BJU International, 117(6B), E36–E45. https://doi.org/10.1111/bju.13179
- Centers for Disease Control and Prevention. (2017). About adult BMI. Retrieved from https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/index.html
- Cormie, P., Galvão, D. A., Spry, N., Joseph, D., Chee, R., Taaffe, D. R., … Newton, R. U. (2015). Can supervised exercise prevent treatment toxicity in patients with prostate cancer initiating androgen-deprivation therapy: A randomised controlled trial. BJU International, 115(2), 256–266. https://doi.org/10.1111/bju.12646
- Donovan, K. A., Walker, L. M., Wassersug, R. J., Thompson, L. M. A., & Robinson, J. W. (2015). Psychological effects of androgen-deprivation therapy on men with prostate cancer and their partners. Cancer, 121, 4286–4299. https://doi.org/10.1002/cncr.29672
- Dorff, T. B., Gross, M. E., Quinn, D. I., Pinski, J. K., Schroeder, E. T., Groshen, S. G., … Kiwata, J. (2017). Impact of resistance exercise on metabolic syndrome (MetS) parameters in men receiving androgen deprivation therapy (ADT) for prostate cancer. Journal of Clinical Oncology, 35(suppl 6), 223. https://doi.org/10.1200/JCO.2017.35.6_suppl.223
- Eckel, R. H., Jakicic, J. M., Ard, J. D., de Jesus, J. M., Houston Miller, N., Hubbard, V. S., … Yanovski, S. Z. (2014). 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk. Journal of the American College of Cardiology, 63(25 Part B), 2960–2984. https://doi.org/10.1016/j.jacc.2013.11.003
- Freedland, S. J., Howard, L., Allen, J., Smith, J., Stout, J., Aronson, W., … Lin, P. H. (2019). A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: Carbohydrate and prostate study 1 (CAPS 1) randomized controlled trial. Prostate Cancer and Prostatic Diseases, https://doi.org/10.1038/s41391-019-0126-5. Advance online publication
- Galvão, D. A., Taaffe, D. R., Spry, N., Joseph, D., & Newton, R. U. (2010). Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: A randomized controlled trial. Journal of Clinical Oncology, 28(2), 340–347. https://doi.org/10.1200/JCO.2009.23.2488
- Gonzalez, B. D., Jim, H. S. L., Booth-Jones, M., Small, B. J., Sutton, S. K., Lin, H. Y., … Jacobsen, P. B. (2015). Course and predictors of cognitive function in patients with prostate cancer receiving androgen-deprivation therapy: A controlled comparison. Journal of Clinical Oncology, 33(18), 2021–2027. https://doi.org/10.1200/JCO.2014.60.1963
- Van Hemelrijck, M., Garmo, H., Holmberg, L., Ingelsson, E., Bratt, O., Bill-Axelson, A., … Adolfsson, J. (2010). Absolute and relative risk of cardiovascular disease in men with prostate cancer: Results from the population-based PCBaSe Sweden. Journal of Clinical Oncology, 28(21), 3448–3456. https://doi.org/10.1200/jco.2010.29.1561
- Hou, X., & Flaig, T. W. (2012). Redefining hormone sensitive disease in advanced prostate cancer. Advances in Urology, 2012, 978531. https://doi.org/10.1155/2012/978531
- Keating, N. L., O'Malley, A., Freedland, S. J., & Smith, M. R. (2012). Diabetes and cardiovascular disease during androgen deprivation therapy: Observational study of veterans with prostate cancer. Journal of the National Cancer Institute, 104(19), 1518–1523. https://doi.org/10.1093/jnci/djs376
- Knols, R., Aaronson, N. K., Uebelhart, D., Fransen, J., & Aufdemkampe, G. (2005). Physical exercise in cancer patients during and after medical treatment: A systematic review of randomized and controlled clinical trials. Journal of Clinical Oncology, 23(16), 3830–3842. https://doi.org/10.1200/JCO.2005.02.148
- Lee, M., Jim, H. S., Fishman, M., Zachariah, B., Heysek, R., Biagioli, M., & Jacobsen, P. B. (2015). Depressive symptomatology in men receiving androgen deprivation therapy for prostate cancer: A controlled comparison. Psycho-oncology, 24(4), 472–477. https://doi.org/10.1002/pon.3608
- Levine, G. N., D'Amico, A. V., Berger, P., Clark, P. E., Eckel, R. H., Keating, N. L., … American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association (2010). Androgen-deprivation therapy in prostate cancer and cardiovascular risk: A science advisory from the American Heart Association, American Cancer Society, and American Urological Association: Endorsed by the American Society for Radiation Oncology. CA: A Cancer Journal for Clinicians, 60(3), 194–201. https://doi.org/10.3322/caac.20061
- van Londen, G. J., Levy, M. E., Perera, S., Nelson, J. B., & Greenspan, S. L. (2008). Body composition changes during androgen deprivation therapy for prostate cancer: A 2-year prospective study. Critical Reviews in Oncology/Hematology, 68(2), 172–177. https://doi.org/10.1016/j.critrevonc.2008.06.006
- Maliski, S. L., Rivera, S., Connor, S., Lopez, G., & Litwin, M. S. (2008). Renegotiating masculine identity after prostate cancer treatment. Qualitative Health Research, 18(12), 1609–1620. https://doi.org/10.1177/1049732308326813
- Nguyen, P. L., Alibhai, S. M. H., Basaria, S., D'Amico, A. V., Kantoff, P. W., Keating, N. L., … Smith, M. R. (2015). Adverse effects of androgen deprivation therapy and strategies to mitigate them. European Urology, 67(5), 825–836. https://doi.org/10.1016/j.eururo.2014.07.010
- NHLBI Obesity Education Initiative Expert Panel on the Identification, Evaluation, and Treatment of Obesity in Adults (US). (1998). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Bethesda (MD): National Heart, Lung, and Blood Institute. (Report No. 98-4083). https://www.ncbi.nlm.nih.gov/books/NBK2004/
- O'Neill, R. F., Haseen, F., Murray, L. J., O'sullivan, J. M., & Cantwell, M. M. (2015). A randomised controlled trial to evaluate the efficacy of a 6-month dietary and physical activity intervention for patients receiving androgen deprivation therapy for prostate cancer. Journal of Cancer Survivorship, 9(3), 431–440. https://doi.org/10.1007/s11764-014-0417-8
- Pagliarulo, V., Bracarda, S., Eisenberger, M. A., Mottet, N., Schröder, F. H., Sternberg, C. N., & Studer, U. E. (2012). Contemporary role of androgen deprivation therapy for prostate cancer. European Urology, 61(1), 11–25. https://doi.org/10.1016/j.eururo.2011.08.026
- Punnen, S., Cooperberg, M. R., D'Amico, A. V., Karakiewicz, P. I., Moul, J. W., Scher, H. I., … Freedland, S. J. (2013). Management of biochemical recurrence after primary treatment of prostate cancer: A systematic review of the literature. European Urology, 64(6), 905–915. https://doi.org/10.1016/j.eururo.2013.05.025
- Salminen, E. K., Portin, R. I., Koskinen, A., Helenius, H., & Nurmi, M. (2004). Associations between serum testosterone fall and cognitive function in prostate cancer patients. Clinical Cancer Research, 10(22), 7575–7582. https://doi.org/10.1158/1078-0432.CCR-04-0750
- Salvador, C., Planas, J., Agreda, F., Placer, J., Trilla, E., Lopez, M. A., & Morote, J. (2013). Analysis of the lipid profile and atherogenic risk during androgen deprivation therapy in prostate cancer patients. Urologia Internationalis, 90(1), 41–44. https://doi.org/10.1159/000342814
- Segal, R. J., Reid, R. D., Courneya, K. S., Malone, S. C., Parliament, M. B., Scott, C. G., … Wells, G. A. (2003). Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. Journal of Clinical Oncology, 21(9), 1653–1659. https://doi.org/10.1200/JCO.2003.09.534
- Sevilla, C., Maliski, S. L., Kwan, L., Connor, S. E., & Litwin, M. S. (2012). Long-term quality of life in disadvantaged men with prostate cancer on androgen deprivation therapy. Prostate Cancer and Prostatic Diseases, 15(3), 237–243. https://doi.org/10.1038/pcan.2011.71
- Shahinian, V. B., Kuo, Y., Freeman, J. L., Orihuela, E., & Goodwin, J. S. (2005). Increasing use of gonadotropin-releasing hormone agonists for the treatment of localized prostate carcinoma. Cancer, 103(8), 1615–1624. https://doi.org/10.1002/cncr.20955
- Sharifi, N., Gulley, J. L., & Dahut, W. L. (2005). Androgen deprivation therapy for prostate cancer. Journal of the American Medical Association, 294(2), 238–244. https://doi.org/10.1001/jama.294.2.238
- Shim, J. S., Oh, K., & Kim, H. C. (2014). Dietary assessment methods in epidemiologic studies. Epidemiology and Health, 36):e2014009. https://doi.org/10.4178/epih/e2014009
- Taylor, L. G., Canfield, S. E., & Du, X. L. (2009). Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer, 115(11), 2388–2399. https://doi.org/10.1002/cncr.24283
- Tsang, V. W., Skead, C., Wassersug, R. J., & Palmer-Hague, J. L. (2019). Impact of prostate cancer treatments on men's understanding of their masculinity. Psychology of Men & Masculinities, 20(2), 215–225. https://doi.org/10.1037/men0000184
- Wall, B. A., Galvão, D. A., Fatehee, N., Taaffe, D. R., Spry, N., Joseph, D., … Newton, R. U. (2017). Exercise Improves V˙O2max and body composition in androgen deprivation therapy–treated prostate cancer patients. Medicine & Science in Sports & Exercise, 49(8), 1503–1510. https://doi.org/10.1249/MSS.0000000000001277
- Wassersug, R. J. (2009). Mastering emasculation. Journal of Clinical Oncology, 27(4), 634–636. https://doi.org/10.1200/JCO.2008.20.1947
- Wei, J. T., Dunn, R. L., Litwin, M. S., Sandler, H. M., & Sanda, M. G. (2000). Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology, 56(6), 899–905. https://www.ncbi.nlm.nih.gov/pubmed/11113727
- Wiseman, M. (2008). The Second World Cancer Research Fund/American Institute for Cancer Research Expert Report. Food, nutrition, physical activity, and the prevention of cancer: A global perspective. Proceedings of the Nutrition Society, 67(3), 253–256. https://doi.org/10.1017/S002966510800712X
- World Cancer Research Fund International/American Institute for Cancer Research Continuous Update Project Report: Diet, Nutrition, Physical Activity, and Prostate Cancer. (2014). Retrieved from www.wcrf.org/sites/default/files/Prostate-Cancer-2014-Report.pdf
- Wu, L. M., Tanenbaum, M. L., Dijkers, M. P., Amidi, A., Hall, S. J., Penedo, F. J., & Diefenbach, M. A. (2016). Cognitive and neurobehavioral symptoms in patients with non-metastatic prostate cancer treated with androgen deprivation therapy or observation: A mixed methods study. Social Science & Medicine (1982), 156, 80–89. https://doi.org/10.1016/j.socscimed.2016.03.016
- Yunfeng, G., Weiyang, H., Xueyang, H., Yilong, H., & Xin, G. (2017). Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. Medicine, 96(27):e7368. https://doi.org/10.1097/MD.0000000000007368
- Zavala, M. W., Maliski, S. L., Kwan, L., Miller, D. C., Fink, A., & Litwin, M. S. (2008). Longitudinal quality of life in low-income men in a state-funded prostate cancer treatment program. Journal of Health Care for the Poor and Underserved, 19(1), 200–214. https://doi.org/10.1353/hpu.2008.0026