Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): Study protocol for a randomised controlled feasibility trial

Trials

Volumn 17, Issue 1, 2016, Pages

  Hackshaw McGeagh, Lucy ^a,b   Lane, J Athene ^a,b   Persad, Raj ^c   Gillatt, David ^c   Holly, Jeff M P ^b   Koupparis, Anthony ^c   Rowe, Edward ^c   Johnston, Lyndsey ^c   Cloete, Jenny ^c   Shiridzinomwa, Constance ^c   Abrams, Paul ^c   Penfold, Chris M ^a   Bahl, Amit ^c,d   Oxley, Jon ^c   Perks, Claire M ^b   Martin, Richard ^a,b  

^a UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

^c SOUTHMEAD HOSPITAL   (United Kingdom)

^d BRISTOL HAEMATOLOGY AND ONCOLOGY CENTRE   (United Kingdom)

Author keywords

Cohort; Intervention; Nutrition; Physical activity; Prostate cancer; Radical prostatectomy; Randomised control trial

Indexed keywords

PROSTATE SPECIFIC ANTIGEN; SOMATOMEDIN; CAROTENOID; LYCOPENE;

ARTICLE; CONTROLLED STUDY; DIETARY INTAKE; FEASIBILITY STUDY; HUMAN; MALE; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PHYSICAL ACTIVITY; PROSTATE CANCER; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; ADVERSE EFFECTS; CLINICAL PROTOCOL; DAIRY PRODUCT; DIET; DIET THERAPY; DIETARY SUPPLEMENT; ENGLAND; EXERCISE; FRUIT; KINESIOTHERAPY; METHODOLOGY; MULTIMODALITY CANCER THERAPY; NUTRITIONAL STATUS; PATHOPHYSIOLOGY; PROCEDURES; PROSTATECTOMY; PROSTATIC NEOPLASMS; TIME FACTOR; TREATMENT OUTCOME; VEGETABLE; WALKING;

CAROTENOIDS; CLINICAL PROTOCOLS; COMBINED MODALITY THERAPY; DAIRY PRODUCTS; DIET; DIETARY SUPPLEMENTS; ENGLAND; EXERCISE; EXERCISE THERAPY; FEASIBILITY STUDIES; FRUIT; HUMANS; MALE; NUTRITIONAL STATUS; PROSTATECTOMY; PROSTATIC NEOPLASMS; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; VEGETABLES; WALKING;

EID: 84959481372     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1248-x     Document Type: Article

References (49)

1. Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001;51(1):15-36.
2. Cancer Research UK. Prostate Cancer Key Facts. 2013. Available from: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/prostate-cancer/. Accessed January 2013.
3. Davies N, Batehup L, Thomas R. The role of diet and physical activity in breast, colorectal, and prostate cancer survivorship: a review of the literature. Br J Cancer. 2011;105 Suppl 1:S52-73. doi: 10.1038/bjc.2011.423.
4. Ligibel J. Lifestyle factors in cancer survivorship. J Clin Oncol. 2012;20(30):3697-704. doi: 10.1200/JCO.2012.42.0638.
5. McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003;18(2):156-70.
6. Hackshaw-McGeagh L, Penfold C, Walsh E, Donovan J, Hamdy F, Neal D, et al. Physical activity, alcohol consumption, BMI and smoking status before and after prostate cancer diagnosis in the ProtecT trial: Opportunities for lifestyle modification. Int J Cancer. 2015; 12. doi: 10.1002/ijc.29514.
7. Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011;29(6):726-32. doi: 10.1200/JCO.2010.31.5226.
8. Committee PAGA. Physical Activity Guidelines Advisory Committee Report, 2008. Washington, DC;Physical Activity Guidelines Advisory Committee: 2008.
9. Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, et al. Gait speed and survival in older adults. JAMA. 2011;305(1):50-8. doi: 10.1001/jama.2010.1923.
10. World Cancer Research Fund. Diet, nutrition, physical activity and prostate cancer. 2014.
11. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
12. Blanchard CM, Courneya KS, Stein K. Cancer survivors' adherence to lifestyle behavior recommendations and associations with health-related quality of life: results from the American Cancer Society's SCS-II. J Clin Oncol. 2008;26(13):2198-204. doi: 10.1200/jco.2007.14.6217.
13. Chan JM, Holick CN, Leitzmann MF, Rimm EB, Willett WC, Stampfer MJ, et al. Diet after diagnosis and the risk of prostate cancer progression, recurrence, and death (United States). Cancer Causes Control. 2006;17(2):199-208. doi: 10.1007/s10552-005-0413-4.
14. Bunker CH, McDonald AC, Evans RW, de la Rosa N, Boumosleh JM, Patrick AL. A randomized trial of lycopene supplementation in Tobago men with high prostate cancer risk. Nutr Cancer. 2007;57(2):130-7. doi: 10.1080/01635580701274046.
15. Neill MG, Fleshner NE. An update on chemoprevention strategies in prostate cancer for 2006. Curr Opin Urol. 2006;16(3):132-7. doi: 10.1097/01.mou.0000193388.31727.d2.
16. Dagnelie PC, Schuurman AG, Goldbohm RA, Van den Brandt PA. Diet, anthropometric measures and prostate cancer risk: a review of prospective cohort and intervention studies. BJU Int. 2004;93(8):1139-50. doi: 10.1111/j.1464-410X.2004.04795.x.
17. Richman EL, Carroll PR, Chan JM. Vegetable and fruit intake after diagnosis and risk of prostate cancer progression. Int J Cancer. 2012;131(1):201-10. doi: 10.1002/ijc.26348.
18. Liu B, Mao Q, Cao M, Xie L. Cruciferous vegetables intake and risk of prostate cancer: a meta-analysis. Int J Urol. 2012;19(2):134-41.
19. Bai XY, Qu X, Jiang X, Xu Z, Yang Y, Su Q, et al. Association between Dietary Vitamin C Intake and Risk of Prostate Cancer: A Meta-analysis Involving 103,658 Subjects. J Cancer. 2015;6(9):913-21. doi: 10.7150/jca.12162.
20. Erdrich S, Bishop KS, Karunasinghe N, Han DY, Ferguson LR. A pilot study to investigate if New Zealand men with prostate cancer benefit from a Mediterranean-style diet. PeerJ. 2015;3:e1080.
21. Hebert JR, Hurley TG, Harmon BE, Heiney S, Hebert CJ, Steck SE. A diet, physical activity, and stress reduction intervention in men with rising prostate-specific antigen after treatment for prostate cancer. Cancer Epidemiol. 2012;36(2):e128-36.
22. Gao X, LaValley MP, Tucker KL. Prospective studies of dairy product and calcium intakes and prostate cancer risk: a meta-analysis. J Natl Cancer Inst. 2005;97(23):1768-77. doi: 10.1093/jnci/dji402.
23. Raimondi S, Mabrouk JB, Shatenstein B, Maisonneuve P, Ghadirian P. Diet and prostate cancer risk with specific focus on dairy products and dietary calcium: a case-control study. Prostate. 2010;70(10):1054-65. doi: 10.1002/pros.21139.
24. Koh KA, Sesso HD, Paffenbarger Jr RS, Lee IM. Dairy products, calcium and prostate cancer risk. Br J Cancer. 2006;95(11):1582-5. doi: 10.1038/sj.bjc.6603475.
25. Yan L, Spitznagel EL. Soy consumption and prostate cancer risk in men: a revisit of a meta-analysis. Am J Clin Nutr. 2009;89(4):1155-63. doi: 10.3945/ajcn.2008.27029.
26. Hwang YW, Kim SY, Jee SH, Kim YN, Nam CM. Soy food consumption and risk of prostate cancer: a meta-analysis of observational studies. Nutr Cancer. 2009;61(5):598-606. doi: 10.1080/01635580902825639.
27. Dalais FS, Meliala A, Wattanapenpaiboon N, Frydenberg M, Suter DAI, Thomson WK, et al. Effects of a diet rich in phytoestrogens on prostate-specific antigen and sex hormones in men diagnosed with prostate cancer. Urology. 2004;64(3):510-5.
28. Bosland MC, Kato I, Zeleniuch-Jacquotte A, Schmoll J, Enk Rueter E, Melamed J, et al. Effect of soy protein isolate supplementation on biochemical recurrence of prostate cancer after radical prostatectomy: a randomized trial. JAMA. 2013;310(2):170-8.
29. Hackshaw-McGeagh LE, Perry RE, Leach VA, Qandil S, Jeffreys M, Martin RM, et al. A systematic review of dietary, nutritional and physical activity interventions for the prevention of prostate cancer progression and mortality. Cancer Causes Control. 2015;26(11):1521-50.
30. Bristol Randomised Trial Collaboration. Available from: http://www.bristol.ac.uk/social-community-medicine/centres/brtc/.
31. National Institute for Health Research (NIHR). Bristol Biomedical Research Unit in Nutrition, Diet and Lifestyle Available from: http://www.uhbristol.nhs.uk/research-innovation/our-research/bristol-nutrition-bru.
32. Ajzen I. The theory of planned behavior. Organ Behav Hum. 1991;50(2):179-211. doi: 10.1016/0749-5978(91)90020-t.
33. Donovan JL, Athene Lane J, Peters TJ, Brindle L, Salter E, Gillatt D, et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol. 2009;62(1):29-36. http://dx.doi.org/ 10.1016/j.jclinepi.2008.02.010.
34. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1.
35. Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, et al. Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter. New Engl J Med. 2004;350(22):2239-46. doi: 10.1056/NEJMoa031918.
36. Rowlands MA, Holly JM, Gunnell D, Donovan J, Lane JA, Hamdy F, et al. Circulating insulin-like growth factors and IGF-binding proteins in PSA-detected prostate cancer: the large case-control study ProtecT. Cancer Res. 2012;72(2):503-15. doi: 10.1158/0008-5472.can-11-1601.
37. Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: Toward an integrative model of change. J Consult Clin Psychol. 1983;51(3):390-5. doi: 10.1037/0022-006X.51.3.390.
38. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Huberman AMaM MB, editor. The qualitative researcher's companion. Thousand Oaks: Sage 2002.
39. International. NQ. 2012. Available from: http://www.qsrinternational.com/products_nvivo.aspx.
40. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
41. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. Ann Intern Med. 2010;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232.
42. Richman EL, Kenfield SA, Chavarro JE, Stampfer MJ, Giovannucci EL, Willett WC, et al. Fat intake after diagnosis and risk of lethal prostate cancer and all-cause mortality. JAMA Intern Med. 2013;173(14):1318-26. doi: 10.1001/jamainternmed.2013.6536.
43. Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, et al. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985;122(1):51-65.
44. Besson H, Brage S, Jakes RW, Ekelund U, Wareham NJ. Estimating physical activity energy expenditure, sedentary time, and physical activity intensity by self-report in adults. Am J Clin Nutr. 2010;91(1):106-14. doi: 10.3945/ajcn.2009.28432.
45. Donovan JL, Peters TJ, Abrams P, Brookes ST. de aa Rosette JJ, Schafer W. Scoring the short form ICSmaleSF questionnaire. International Continence Society. J Urol. 2000;164(6):1948-55.
46. McNair D, Lorr M, Droppleman L. EdITS manual for the Profile of Mood State. San Diego: EdITS Educational & Industrial Testing Service; 1992.
47. Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, et al. Cognitive-behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Health Psychol. 2001;20(1):20-32.
48. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003;1:79. doi: 10.1186/1477-7525-1-79.
49. Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220-33.