Testicular Awareness: The What, the Why, and the How
Main Article Content
Abstract
Health outcomes among men are poorer than women and little efforts have been made by health organizations to promote men’s health. Testicular disorders can have a negative effect on men’s health and are rarely addressed in pre-existing men’s health policies. Findings from the empirical literature on men’s awareness of testicular disorders suggest that men’s knowledge of testicular disorders is lacking and their intentions to seek timely medical attention for testicular symptoms are low. This paper aims to introduce the concept of ‘testicular awareness’ and explore its implications for health research, practice, and education. The key attributes of ‘testicular awareness’ include: (i) familiarity with own testes; (ii) knowing what is normal versus abnormal; (iii) ability to detect an abnormality; and (iv) knowing own risk factors. Testicular awareness is an all-encompassing concept since it helps men become familiar with a body part that is seldom discussed and enables them to detect testicular abnormalities and to seek timely medical attentions for testicular symptoms, regardless of the ultimate diagnosis. Testicular awareness can be promoted using a number of strategies; these include but are not limited to: (i) involving men in drafting men’s health policies that address testicular awareness; (ii) partnering with men to develop and test interventions promoting testicular awareness; (iii) being cognizant of the learning needs of men who are at risk of health disparities including those with low literacy and health literacy; (iv) promoting testicular awareness in clinical practice and health education; and (v) using men’s daily spheres of information (e.g. workplaces, universities, gyms, and community organizations) to promote testicular awareness.
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Saab, M. M., Hegarty, J., & Landers, M. (2019). Testicular Awareness: The What, the Why, and the How. International Journal of Mens Social and Community Health, 2(1), e1-e10. https://doi.org/10.22374/ijmsch.v2i1.16
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Editorial
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References
1. Hawkes S, Buse K. Gender and global health: evidence, policy, and inconvenient truths. Lancet 2013;381:1783-7.
2. McKinlay E, Kljakovic M, McBain L. New Zealand men's health care: are we meeting the needs of men in general practice? J Prim Health Care 2009;1(4):302-10.
3. Baker P, Dworkin SL, Tong S, et al. The men’s health gap: Men must be included in the global health equity agenda. Bulletin of the World Health Organization 2014;92:618-20.
4. Baker P, Brown A. Men’s health: time for a policy response. Int J Mens Soc Com Health 2018;1(1):e1-e5;
5. National Cancer Institute. SEER stat fact sheets: Testis cancer. 2018; http://seer.cancer.gov/statfacts/html/testis.html. Accessed November 1, 2018.
6. Rosen A, Jayram G, Drazer M, Eggener SE. Global trends in testicular cancer incidence and mortality. Eur Urol 2011;60:374-9.
7. Znaor A, Lortet-Tieulent J, Jemal A, Bray F. International variations and trends in testicular cancer incidence and mortality. Eur Urol 2014;65:1095-106.
8. Albers P, Albrecht W, Algaba F, et al. Guidelines on testicular cancer: 2015 update. Eur Urolog 2015;68(6):1054-68.
9. Sprauten M, Haugnes HS, Brydøy M, et al. Chronic fatigue in 812 testicular cancer survivors during long-term follow-up: increasing prevalence and risk factors. Ann Oncol 2015; 26:2133-40.
10. Cioroiu C, Weimer LH. Update on chemotherapy-induced peripheral neuropathy. Curr Neurol Neurosci 2017;17:47.
11. Fung C, Dinh P Jr, Ardeshir-Rouhani-Fard S, et al. Toxicities associated with cisplatin-based chemotherapy and radiotherapy in long-term testicular cancer survivors. Adv Urol 2018:8671832.
12. Haugnes HS, Oldenburg J, Bremnes RM. Pulmonary and cardiovascular toxicity in long-term testicular cancer survivors. Urol Oncol 2015;33(9):399-406.
13. Haugnes HS, Bosl GJ, Boer H, et al. Long-term and late effects of germ cell testicular cancer treatment and implications for follow-up. J Clin Oncol 2012;30(30):3752-63.
14. Oldenburg J. Hypogonadism and fertility issues following primary treatment for testicular cancer. Urolo Oncol 2015;33:407-12.
15. Bayne CE, Villanueva J, Davis TD, et al. Factors associated with delayed presentation and misdiagnosis of testicular torsion: a case-control study. J Pediatr 2017;186:200-4.
16. Saxena AK, Castellani C, Ruttenstock EM, Höllwarth ME. Testicular torsion: a 15-year single-centre clinical and histological analysis. Acta Paediatr 2012;101(7):e282-6.
17. Tanner R., Twomey M, Maher MM, et al. A rare cause of testicular pain: thrombosis of the pampiniform plexus. Ir Med J 2016;109(1):347-8.
18. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines – Epididymitis. 2015; http://www.cdc.gov/std/tg2015/epididymitis.htm.
Accessed November 1, 2018.
19. Norões J, Dreyer G. A mechanism for chronic filarial hydrocele with implications for its surgical repair. PLoS Negl Trop Dis 2010;4(6):e695.
20. World Health Organisation. Lymphatic filariasis. 2018; http://www.who.int/mediacentre/factsheets/fs102/en/ Accessed November 1, 2018.
21. Saab MM, Landers M, Hegarty J. Males’ awareness of benign testicular disorders: an integrative review. Am J Mens Health 2018;12(3):556-66.
22. Saab MM, Landers M, Hegarty J. Testicular cancer awareness and screening practices: a systematic review. Oncol Nurs Forum 2016;43(1):E8-23.
23. Saab MM, Landers M, Hegarty J. Promoting testicular cancer awareness and screening: a systematic review of interventions. Cancer Nurs 2016;39(6):473-87.
24. Saab MM, Davoren M, Murphy A, et al. Promoting men’s awareness, self-examination, and help-seeking for testicular disorders: a systematic review of interventions. HRB Open Research. https://hrbopenresearch.org/articles/1-16/v2 Accessed November 1, 2018.
25. Thornton H, Pillarisetti RR. ‘Breast awareness’ and ‘breast self-examination’ are not the same. What do these terms mean? Why are they confused? What can we do? Eur J Cancer 2008;44:2118-21.
26. Semiglazov VF, Manikhas AG, Moiseenko VM, et al. Results of a prospective randomized investigation to evaluate the significance of self-examination for the early detection of breast cancer. Vopr Onkol 2003;49:434-41.
27. Thomas DB, Gao DL, Ray RM, et al. Randomized trial of breast self-examination in Shanghai: final results. J Natl Cancer Inst 2002;94:1445-57.
28. Scott S, Walter, F. Studying help-seeking for symptoms: the challenges of methods and models. Soc Personal Psychol Compass 2010;4:531-47.
29. Mohammed A, Chinegwundoh F. Testicular varicocele: an overview. Urol Int 2009;82:373-9.
30. Goldstein M, Mehta A. Male reproductive system. In: Standring S, eds. Gray's Anatomy: The Anatomical Basis of Clinical Practice. 41st edition. London: Elsevier; 2016:1272-1286.
31. Saab M, Noureddine S, Abu-Saad Huijer H, Dejong J. Surviving testicular cancer: the Lebanese lived experience. Nurs Res 2014;63(3):203-10.
32. Saab MM, Landers M, Hegarty J. Exploring awareness and help-seeking intentions for testicular symptoms among heterosexual, gay, and bisexual men in Ireland: a qualitative descriptive study. Int J Nurs Stud 2017;67:41-50.
33. Saab MM, Landers M, Cooke E, et al. Enhancing men's awareness of testicular disorders using a virtual reality intervention: a pre-post pilot study. Nus Res;67(5):349-58.
34. Ringdahl E, Teague L. Testicular torsion. Am Fam Physician 2006;74(10):1739-43.
35. Trojian TH, Lishnak TS, Heiman D. Epididymitis and orchitis: an overview. . Am Fam Physician 2009;79(7):583-7.
36. Cancer Research UK. Testicular cancer statistics. 2018; https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/testicular-cancer. Accessed November 1, 2018.
37. Fish JA, Prichard I, Ettridge K, et al. Psychosocial factors that influence men’s help-seeking for cancer symptoms: a systematic synthesis of mixed methods research. Psychooncology;24(10):1222-32.
38. Lin K, Sharangpani R. Screening for testicular cancer: an evidence review for the U.S. Preventive Services Task Force. Ann Intern Med 2010;153(6):396-9.
39. Ilic D, Misso ML. Screening for testicular cancer. Cochrane Database Syst Rev 2011;(2):CD007853.
40. U.S. Preventive Services Task Force. Screening for testicular cancer: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med 2011;154(7):483-6.
41. National Cancer Institute. Testicular cancer screening (PDQ®)–health professional version. 2018; https://www.cancer.gov/types/testicular/hp/testicular-screening-pdq. Accessed November 1, 2018.
42. Rovito MJ, Manjelievskaia J, Leone JE, et al. From 'D' to 'I': a critique of the current United States preventive services task force recommendation for testicular cancer screening. Prev Med Rep 2016;3:361-6.
43. Aberger M, Wilson B, Holzbeierlein JM, et al. Testicular self-examination and testicular cancer: a cost-utility analysis. Cancer Med 2014;3(6):1629-34.
44. McGuinness LA, Obeidat S, Hickerton B, Long R. Has increasing public health awareness influenced the size of testicular tumours among adult populations over the last 40 years? J Public Health (Oxf) 2017;39(1):90-4.
45. American Cancer Society. Can testicular cancer be found early? 2018; https://www.cancer.org/cancer/testicular-cancer/detection-diagnosis-staging/detection.html. Accessed November 1, 2018.
46. Cancer Research UK. Testicular cancer – finding it early. 2018; https://www.cancerresearchuk.org/about-cancer/testicular-cancer/getting-diagnosed/finding-early. Accessed November 1, 2018.
47. European Union. The state of men’s health in Europe. 2011; https://ec.europa.eu/health/sites/health/files/state/docs/men_health_extended_en.pdf. Accessed November 1, 2018.
48. World Health Organization. The health and well-being of men in the WHO European Region: better health through a gender approach. 2018; http://www.euro.who.int/__data/assets/pdf_file/0007/380716/mhr-report-eng.pdf?ua=1. Accessed November 1, 2018.
49. Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect 2014;17(5):637-50.
50. Medical Research Charities Group. The health research landscape in Ireland: what researchers say. 2014; https://www.mrcg.ie/assets/91/D6C91C07-083D-B049-D8E487D430FE9151_document/MRCG_Research_Report.pdf. Accessed November 1, 2018.
51. Saab MM, Landers M, Hegarty J. Exploring men's preferred strategies for learning about testicular disorders inclusive of testicular cancer: A qualitative descriptive study. Eur J Oncol Nurs 2017;26:27-35.
52. Saab MM, Reidy M, Hegarty J, et al. Men's information-seeking behavior regarding cancer risk and screening: A meta-narrative systematic review. Psychooncology 2018;27(2):410-9.
53. Saab MM, Landers M, Cooke E, et al. Feasibility and usability of a virtual reality intervention to enhance men’s awareness of testicular disorders (E‑MAT). Virtual Reality 2018. https://doi.org/10.1007/s10055-018-0368-x
54. Michie S, Johnston M, Francis J, et al. From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Applied Psychol 2008;57:660-80. doi:10.1111/j.1464-0597.2008.00341.x
55. Savage E, Farrel D, McManus V, Grey M. The science of intervention development for type 1 diabetes in childhood: a systematic review. J Adv Nurs 2010;66(12):2604-19.
56. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud 2013;50(5):587-92.
57. Wanzer MB, Foster C, Servoss T, LaBelle S. Educating young men about testicular cancer: support for a comprehensive testicular cancer campaign. J Health Commun 2014;19(3):303-20.
58. Rovito MJ, Gordon TF, Bass SB, et al. Developing the “Control Identity” typology to create more effective testicular health promotional messaging. Am J Mens Health 2018;12(3):546-55.
59. Saab MM, Landers M, Hegarty J. The Preconscious Awareness to Action Framework: an application to promote testicular awareness. Nurs Res 2018;67(2):169-176.
60. Babu BV, Hazra RK, Chhotray GP, Satyanarayana K. Knowledge and beliefs about elephantiasis and hydrocele of lymphatic filariasis and some socio-demographic determinants in an endemic community of Eastern India. Public Health 2004;118(2): 121-7.
61. Reidy M, Saab MM, Hegarty J, et al. Promoting men's knowledge of cancer risk reduction: a systematic review of interventions. Patient Educ Couns 2018;101(8):1322-36.
62. Hunt K, Wyke S, Gray CM, et al. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial. Lancet 2014;383(9924):1211-21.
2. McKinlay E, Kljakovic M, McBain L. New Zealand men's health care: are we meeting the needs of men in general practice? J Prim Health Care 2009;1(4):302-10.
3. Baker P, Dworkin SL, Tong S, et al. The men’s health gap: Men must be included in the global health equity agenda. Bulletin of the World Health Organization 2014;92:618-20.
4. Baker P, Brown A. Men’s health: time for a policy response. Int J Mens Soc Com Health 2018;1(1):e1-e5;
5. National Cancer Institute. SEER stat fact sheets: Testis cancer. 2018; http://seer.cancer.gov/statfacts/html/testis.html. Accessed November 1, 2018.
6. Rosen A, Jayram G, Drazer M, Eggener SE. Global trends in testicular cancer incidence and mortality. Eur Urol 2011;60:374-9.
7. Znaor A, Lortet-Tieulent J, Jemal A, Bray F. International variations and trends in testicular cancer incidence and mortality. Eur Urol 2014;65:1095-106.
8. Albers P, Albrecht W, Algaba F, et al. Guidelines on testicular cancer: 2015 update. Eur Urolog 2015;68(6):1054-68.
9. Sprauten M, Haugnes HS, Brydøy M, et al. Chronic fatigue in 812 testicular cancer survivors during long-term follow-up: increasing prevalence and risk factors. Ann Oncol 2015; 26:2133-40.
10. Cioroiu C, Weimer LH. Update on chemotherapy-induced peripheral neuropathy. Curr Neurol Neurosci 2017;17:47.
11. Fung C, Dinh P Jr, Ardeshir-Rouhani-Fard S, et al. Toxicities associated with cisplatin-based chemotherapy and radiotherapy in long-term testicular cancer survivors. Adv Urol 2018:8671832.
12. Haugnes HS, Oldenburg J, Bremnes RM. Pulmonary and cardiovascular toxicity in long-term testicular cancer survivors. Urol Oncol 2015;33(9):399-406.
13. Haugnes HS, Bosl GJ, Boer H, et al. Long-term and late effects of germ cell testicular cancer treatment and implications for follow-up. J Clin Oncol 2012;30(30):3752-63.
14. Oldenburg J. Hypogonadism and fertility issues following primary treatment for testicular cancer. Urolo Oncol 2015;33:407-12.
15. Bayne CE, Villanueva J, Davis TD, et al. Factors associated with delayed presentation and misdiagnosis of testicular torsion: a case-control study. J Pediatr 2017;186:200-4.
16. Saxena AK, Castellani C, Ruttenstock EM, Höllwarth ME. Testicular torsion: a 15-year single-centre clinical and histological analysis. Acta Paediatr 2012;101(7):e282-6.
17. Tanner R., Twomey M, Maher MM, et al. A rare cause of testicular pain: thrombosis of the pampiniform plexus. Ir Med J 2016;109(1):347-8.
18. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines – Epididymitis. 2015; http://www.cdc.gov/std/tg2015/epididymitis.htm.
Accessed November 1, 2018.
19. Norões J, Dreyer G. A mechanism for chronic filarial hydrocele with implications for its surgical repair. PLoS Negl Trop Dis 2010;4(6):e695.
20. World Health Organisation. Lymphatic filariasis. 2018; http://www.who.int/mediacentre/factsheets/fs102/en/ Accessed November 1, 2018.
21. Saab MM, Landers M, Hegarty J. Males’ awareness of benign testicular disorders: an integrative review. Am J Mens Health 2018;12(3):556-66.
22. Saab MM, Landers M, Hegarty J. Testicular cancer awareness and screening practices: a systematic review. Oncol Nurs Forum 2016;43(1):E8-23.
23. Saab MM, Landers M, Hegarty J. Promoting testicular cancer awareness and screening: a systematic review of interventions. Cancer Nurs 2016;39(6):473-87.
24. Saab MM, Davoren M, Murphy A, et al. Promoting men’s awareness, self-examination, and help-seeking for testicular disorders: a systematic review of interventions. HRB Open Research. https://hrbopenresearch.org/articles/1-16/v2 Accessed November 1, 2018.
25. Thornton H, Pillarisetti RR. ‘Breast awareness’ and ‘breast self-examination’ are not the same. What do these terms mean? Why are they confused? What can we do? Eur J Cancer 2008;44:2118-21.
26. Semiglazov VF, Manikhas AG, Moiseenko VM, et al. Results of a prospective randomized investigation to evaluate the significance of self-examination for the early detection of breast cancer. Vopr Onkol 2003;49:434-41.
27. Thomas DB, Gao DL, Ray RM, et al. Randomized trial of breast self-examination in Shanghai: final results. J Natl Cancer Inst 2002;94:1445-57.
28. Scott S, Walter, F. Studying help-seeking for symptoms: the challenges of methods and models. Soc Personal Psychol Compass 2010;4:531-47.
29. Mohammed A, Chinegwundoh F. Testicular varicocele: an overview. Urol Int 2009;82:373-9.
30. Goldstein M, Mehta A. Male reproductive system. In: Standring S, eds. Gray's Anatomy: The Anatomical Basis of Clinical Practice. 41st edition. London: Elsevier; 2016:1272-1286.
31. Saab M, Noureddine S, Abu-Saad Huijer H, Dejong J. Surviving testicular cancer: the Lebanese lived experience. Nurs Res 2014;63(3):203-10.
32. Saab MM, Landers M, Hegarty J. Exploring awareness and help-seeking intentions for testicular symptoms among heterosexual, gay, and bisexual men in Ireland: a qualitative descriptive study. Int J Nurs Stud 2017;67:41-50.
33. Saab MM, Landers M, Cooke E, et al. Enhancing men's awareness of testicular disorders using a virtual reality intervention: a pre-post pilot study. Nus Res;67(5):349-58.
34. Ringdahl E, Teague L. Testicular torsion. Am Fam Physician 2006;74(10):1739-43.
35. Trojian TH, Lishnak TS, Heiman D. Epididymitis and orchitis: an overview. . Am Fam Physician 2009;79(7):583-7.
36. Cancer Research UK. Testicular cancer statistics. 2018; https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/testicular-cancer. Accessed November 1, 2018.
37. Fish JA, Prichard I, Ettridge K, et al. Psychosocial factors that influence men’s help-seeking for cancer symptoms: a systematic synthesis of mixed methods research. Psychooncology;24(10):1222-32.
38. Lin K, Sharangpani R. Screening for testicular cancer: an evidence review for the U.S. Preventive Services Task Force. Ann Intern Med 2010;153(6):396-9.
39. Ilic D, Misso ML. Screening for testicular cancer. Cochrane Database Syst Rev 2011;(2):CD007853.
40. U.S. Preventive Services Task Force. Screening for testicular cancer: U.S. Preventive Services Task Force reaffirmation recommendation statement. Ann Intern Med 2011;154(7):483-6.
41. National Cancer Institute. Testicular cancer screening (PDQ®)–health professional version. 2018; https://www.cancer.gov/types/testicular/hp/testicular-screening-pdq. Accessed November 1, 2018.
42. Rovito MJ, Manjelievskaia J, Leone JE, et al. From 'D' to 'I': a critique of the current United States preventive services task force recommendation for testicular cancer screening. Prev Med Rep 2016;3:361-6.
43. Aberger M, Wilson B, Holzbeierlein JM, et al. Testicular self-examination and testicular cancer: a cost-utility analysis. Cancer Med 2014;3(6):1629-34.
44. McGuinness LA, Obeidat S, Hickerton B, Long R. Has increasing public health awareness influenced the size of testicular tumours among adult populations over the last 40 years? J Public Health (Oxf) 2017;39(1):90-4.
45. American Cancer Society. Can testicular cancer be found early? 2018; https://www.cancer.org/cancer/testicular-cancer/detection-diagnosis-staging/detection.html. Accessed November 1, 2018.
46. Cancer Research UK. Testicular cancer – finding it early. 2018; https://www.cancerresearchuk.org/about-cancer/testicular-cancer/getting-diagnosed/finding-early. Accessed November 1, 2018.
47. European Union. The state of men’s health in Europe. 2011; https://ec.europa.eu/health/sites/health/files/state/docs/men_health_extended_en.pdf. Accessed November 1, 2018.
48. World Health Organization. The health and well-being of men in the WHO European Region: better health through a gender approach. 2018; http://www.euro.who.int/__data/assets/pdf_file/0007/380716/mhr-report-eng.pdf?ua=1. Accessed November 1, 2018.
49. Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect 2014;17(5):637-50.
50. Medical Research Charities Group. The health research landscape in Ireland: what researchers say. 2014; https://www.mrcg.ie/assets/91/D6C91C07-083D-B049-D8E487D430FE9151_document/MRCG_Research_Report.pdf. Accessed November 1, 2018.
51. Saab MM, Landers M, Hegarty J. Exploring men's preferred strategies for learning about testicular disorders inclusive of testicular cancer: A qualitative descriptive study. Eur J Oncol Nurs 2017;26:27-35.
52. Saab MM, Reidy M, Hegarty J, et al. Men's information-seeking behavior regarding cancer risk and screening: A meta-narrative systematic review. Psychooncology 2018;27(2):410-9.
53. Saab MM, Landers M, Cooke E, et al. Feasibility and usability of a virtual reality intervention to enhance men’s awareness of testicular disorders (E‑MAT). Virtual Reality 2018. https://doi.org/10.1007/s10055-018-0368-x
54. Michie S, Johnston M, Francis J, et al. From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques. Applied Psychol 2008;57:660-80. doi:10.1111/j.1464-0597.2008.00341.x
55. Savage E, Farrel D, McManus V, Grey M. The science of intervention development for type 1 diabetes in childhood: a systematic review. J Adv Nurs 2010;66(12):2604-19.
56. Craig P, Dieppe P, Macintyre S, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud 2013;50(5):587-92.
57. Wanzer MB, Foster C, Servoss T, LaBelle S. Educating young men about testicular cancer: support for a comprehensive testicular cancer campaign. J Health Commun 2014;19(3):303-20.
58. Rovito MJ, Gordon TF, Bass SB, et al. Developing the “Control Identity” typology to create more effective testicular health promotional messaging. Am J Mens Health 2018;12(3):546-55.
59. Saab MM, Landers M, Hegarty J. The Preconscious Awareness to Action Framework: an application to promote testicular awareness. Nurs Res 2018;67(2):169-176.
60. Babu BV, Hazra RK, Chhotray GP, Satyanarayana K. Knowledge and beliefs about elephantiasis and hydrocele of lymphatic filariasis and some socio-demographic determinants in an endemic community of Eastern India. Public Health 2004;118(2): 121-7.
61. Reidy M, Saab MM, Hegarty J, et al. Promoting men's knowledge of cancer risk reduction: a systematic review of interventions. Patient Educ Couns 2018;101(8):1322-36.
62. Hunt K, Wyke S, Gray CM, et al. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial. Lancet 2014;383(9924):1211-21.