The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial

Brian C Focht, Alexander R Lucas, Elizabeth Grainger, Christina Simpson, Jennifer M Thomas-Ahner, Steven K Clinton, Brian C Focht, Alexander R Lucas, Elizabeth Grainger, Christina Simpson, Jennifer M Thomas-Ahner, Steven K Clinton

Abstract

Background: Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach, and may offset, or even reverse, the adverse effects accompanying ADT. Unfortunately, the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects. Consequently, the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer.

Methods/design: A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care. Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity, dietary behavior, body composition, muscular strength, and quality of life. Outcomes will be obtained at baseline, 2-month, and 3-month assessments by trial personnel blinded to participants' randomization assignment.

Discussion: Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT.

Trial registration: ClinicalTrials.gov NCT02050906.

Figures

Figure 1
Figure 1
Design of the IDEA-P trial.

References

    1. Cooperberg MR, Moul JW, Carroll PR. The changing face of prostate cancer. J Clin Oncol. 2005;23:8146–8151. doi: 10.1200/JCO.2005.02.9751.
    1. Basaria S, Lieb J, 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf) 2002;56:779–786. doi: 10.1046/j.1365-2265.2002.01551.x.
    1. Boxer RS, Kenny AM, Dowsett R, Taxel P. The effect of 6 months of androgen deprivation therapy on muscle and fat mass in older men with localized prostate cancer. Aging Male. 2005;8:207–212. doi: 10.1080/13685530500361226.
    1. Bylow K, Dale W, Mustian K, Stadler WM, Rodin M, Hall W, Lachs M, Mohile SG. Falls and physical performance deficits in older patients with prostate cancer undergoing androgen deprivation therapy. Urology. 2008;72:422–427. doi: 10.1016/j.urology.2008.03.032.
    1. Bylow K, Mohile SG, Stadler WM, Dale W. Does androgen-deprivation therapy accelerate the development of frailty in older men with prostate cancer?: a conceptual review. Cancer. 2007;110:2604–2613. doi: 10.1002/cncr.23084.
    1. Chen Z, Maricic M, Nguyen P, Ahmann FR, Bruhn R, Dalkin BL. Low bone density and high percentage of body fat among men who were treated with androgen deprivation therapy for prostate carcinoma. Cancer. 2002;95:2136–2144. doi: 10.1002/cncr.10967.
    1. Dacal K, Sereika SM, Greenspan SL. Quality of life in prostate cancer patients taking androgen deprivation therapy. J Am Geriatr Soc. 2006;54:85–90. doi: 10.1111/j.1532-5415.2005.00567.x.
    1. Diamond TH, Higano CS, Smith MR, Guise TA, Singer FR. Osteoporosis in men with prostate carcinoma receiving androgen-deprivation therapy: recommendations for diagnosis and therapies. Cancer. 2004;100:892–899. doi: 10.1002/cncr.20056.
    1. Levine GN, D’Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N. 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. Circulation. 2010;121(6):833–840. doi: 10.1161/CIRCULATIONAHA.109.192695.
    1. Courneya KS, Stevinson C, Vallance JKH. Exercise and Psychosocial Issues for Cancer Survivors. Hoboken, NJ: Wiley & Sons; 2007.
    1. Crawford ED. Epidemiology of prostate cancer. Urology. 2003;62:3–12. doi: 10.1016/j.urology.2003.10.013.
    1. Ruchlin HS, Pellissier JM. An economic overview of prostate carcinoma. Cancer. 2001;92:2796–2810. doi: 10.1002/1097-0142(20011201)92:11<2796::AID-CNCR10124>;2-R.
    1. American Cancer Society . Cancer Facts and Figures 2005. GA: Atlanta; 2005.
    1. American Cancer Society . Cancer Facts and Figures 2006. GA: Atlanta; 2006.
    1. Holzbeierlein JM, McLaughlin MD, Thrasher JB. Complications of androgen deprivation therapy for prostate cancer. Curr Opin Urol. 2004;14:177–183. doi: 10.1097/00042307-200405000-00007.
    1. Joly F, Alibhai SM, Galica J, Park A, Yi QL, Wagner L, Tannock IF. Impact of androgen deprivation therapy on physical and cognitive function, as well as quality of life of patients with nonmetastatic prostate cancer. J Urol. 2006;176:2443–2447. doi: 10.1016/j.juro.2006.07.151.
    1. Kornblith AB, Herr HW, Ofman US, Scher HI, Holland JC. Quality of life of patients with prostate cancer and their spouses. The value of a data base in clinical care. Cancer. 1994;73:2791–2802. doi: 10.1002/1097-0142(19940601)73:11<2791::AID-CNCR2820731123>;2-9.
    1. Carmack Taylor CL, Smith MA, de Moor C, Dunn AL, Pettaway C, Sellin R, Charnsangavej C, Hansen MC, Gritz ER. Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial. Control Clin Trials. 2004;25:265–285. doi: 10.1016/j.cct.2004.03.001.
    1. Courneya KS. Exercise in cancer survivors: an overview of research. Med Sci Sports Exerc. 2003;35:1846–1852. doi: 10.1249/01.MSS.0000093622.41587.B6.
    1. Courneya KS, Friedenreich CM. Relationship between exercise pattern across the cancer experience and current quality of life in colorectal cancer survivors. J Altern Complement Med. 1997;3:215–226. doi: 10.1089/acm.1997.3.215.
    1. Dimeo FC, Tilmann MH, Bertz H, Kanz L, Mertelsmann R, Keul J. Aerobic exercise in the rehabilitation of cancer patients after high dose chemotherapy and autologous peripheral stem cell transplantation. Cancer. 1997;79:1717–1722. doi: 10.1002/(SICI)1097-0142(19970501)79:9<1717::AID-CNCR12>;2-0.
    1. Galvao DA, Newton RU. Review of exercise intervention studies in cancer patients. J Clin Oncol. 2005;23:899–909. doi: 10.1200/JCO.2005.06.085.
    1. Galvao DA, Taaffe DR, Spry N, Joseph D, Turner D, Newton RU. Reduced muscle strength and functional performance in men with prostate cancer undergoing androgen suppression: a comprehensive cross-sectional investigation. Prostate Cancer Prostatic Dis. 2009;12:198–203. doi: 10.1038/pcan.2008.51.
    1. Nelson ME, Fiatarone MA, Morganti CM, Trice I, Greenberg RA, Evans WJ. Effects of high-intensity strength training on multiple risk factors for osteoporotic fractures. A randomized controlled trial. JAMA. 1994;272:1909–1914. doi: 10.1001/jama.1994.03520240037038.
    1. Nieman DC, Cook VD, Henson DA, Suttles J, Rejeski WJ, Ribisl PM, Fagoaga OR, Nehlsen-Cannarella SL. Moderate exercise training and natural killer cell cytotoxic activity in breast cancer patients. Int J Sports Med. 1995;16:334–337. doi: 10.1055/s-2007-973015.
    1. Peters C, Lotzerich H, Niemeier B, Schule K, Uhlenbruck G. Influence of a moderate exercise training on natural killer cytotoxicity and personality traits in cancer patients. Anticancer Res. 1994;14:1033–1036.
    1. Peters C, Lotzerich H, Niemeir B, Schule K, Uhlenbruck G. Exercise, cancer and the immune response of monocytes. Anticancer Res. 1995;15:175–179.
    1. Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005;14:1588–1595. doi: 10.1158/1055-9965.EPI-04-0703.
    1. Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, Venner PM, Quinney HA, Jones LW, D’Angelo ME, Wells GA. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol. 2003;21:1653–1659. doi: 10.1200/JCO.2003.09.534.
    1. Durak EP, Lilly PC. The application of an exercise and wellness program for cancer patients: a preliminary outcomes report. J Strength Cond Res. 1998;12:3–6.
    1. Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008;16:987–997. doi: 10.1007/s00520-008-0411-7.
    1. Goldberg JH, King AC. Physical activity and weight management across the lifespan. Annu Rev Public Health. 2007;28:145–170. doi: 10.1146/annurev.publhealth.28.021406.144105.
    1. Jakicic JM, Otto AD. Treatment and prevention of obesity: what is the role of exercise? Nutr Rev. 2006;64:S57–S61. doi: 10.1111/j.1753-4887.2006.tb00235.x.
    1. Wing RR. Cross-cutting themes in maintenance of behavior change. Health Psychol. 2000;19:84–88. doi: 10.1037/0278-6133.19.Suppl1.84.
    1. Bourke L, Doll H, Crank H, Daley A, Rosario D, Saxton JM. Lifestyle intervention in men with advanced prostate cancer receiving androgen suppression therapy: a feasibility study. Cancer Epidemiol Biomarkers Prev. 2011;20:647–657. doi: 10.1158/1055-9965.EPI-10-1143.
    1. Bourke L, Gilbert S, Hooper R, Steed LA, Joshi M, Catto JW, Saxton JM, Rosario DJ. 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. Eur Urol. 2014;65:865–872. doi: 10.1016/j.eururo.2013.09.040.
    1. Nobes JP, Langley SE, Klopper T, Russell-Jones D, Laing RW. A prospective, randomized pilot study evaluating the effects of metformin and lifestyle intervention on patients with prostate cancer receiving androgen deprivation therapy. BJU Int. 2012;109:1495–1502. doi: 10.1111/j.1464-410X.2011.10555.x.
    1. Ettinger WH, Jr, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, Shumaker S, Berry MJ, O’Toole M, Monu J, Craven T. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST) JAMA. 1997;277:25–31. doi: 10.1001/jama.1997.03540250033028.
    1. Focht BC. Effectiveness of exercise interventions in reducing pain symptoms among older adults with knee osteoarthritis: a review. J Aging Phys Act. 2006;14:212–235.
    1. Rejeski WJ, Brawley LR, Ambrosius WT, Brubaker PH, Focht BC, Foy CG, Fox LD. Older adults with chronic disease: benefits of group-mediated counseling in the promotion of physically active lifestyles. Health Psychol. 2003;22:414–423. doi: 10.1037/0278-6133.22.4.414.
    1. Bandura A. Self-Efficacy: The Exercise of Control. New York: WH Freeman; 1997.
    1. Focht BC, Garver MJ, Devor ST, Dials J, Rose M, Lucas AR, Emery CF, Hackshaw K, Rejeski WJ. Improving maintenance of physical activity in older, knee osteoarthritis patients trial-pilot (IMPACT-P): Design and methods. Contemp Clin Trials. 2012;33:976–982. doi: 10.1016/j.cct.2012.04.012.
    1. Rejeski WJ, Brubaker PH, Goff DC, Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011;171:880–886. doi: 10.1001/archinternmed.2010.522.
    1. Rejeski WJ, Fielding RA, Blair SN, Guralnik JM, Gill TM, Hadley EC, King AC, Kritchevsky SB, Miller ME, Newman AB, Pahor M. The lifestyle interventions and independence for elders (LIFE) pilot study: design and methods. Contemp Clin Trials. 2005;26:141–154. doi: 10.1016/j.cct.2004.12.005.
    1. McAuley E, Konopack JF, Motl RW, Rosengren K, Morris KS. Measuring disability and function in older women: psychometric properties of the Late-Life Function and Disability Instrument. J Gerontol A Biol Sci Med Sci. 2005;60:901–909. doi: 10.1093/gerona/60.7.901.
    1. Reboussin BA, Rejeski WJ, Martin K, Callahan K, Dunn AL, King AC, Sallis JF. Correlates of satisfaction with body function and body appearance in older aged adults: The activity counseling trial. Psychol Health. 2000;15:239–254. doi: 10.1080/08870440008400304.
    1. Rejeski WJ, Ettinger WH, Jr, Schumaker S, James P, Burns R, Elam JT. Assessing performance-related disability in patients with knee osteoarthritis. Osteoarthritis Cartilage. 1995;3:157–167. doi: 10.1016/S1063-4584(05)80050-0.
    1. Focht BC, Rejeski WJ, Ambrosius WT, Katula JA, Messier SP. Exercise, self-efficacy, and mobility performance in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005;53:659–665. doi: 10.1002/art.21466.
    1. Baechle TR, Earle RW. Essentials of Strength Training and Conditioning. Champaign, IL: Human Kinetics; 2008.
    1. American College of Sports Medicine . ACSM’s Guidelines for Exercise Testing and Prescription. Philadelphia, PA: Lippincott Williams & Wilkins; 2010.
    1. Heymsfield SB, Lichtman S, Baumgartner RN, Wang J, Kamen Y, Aliprantis A, Pierson RN., Jr Body composition of humans: comparison of two improved four-compartment models that differ in expense, technical complexity, and radiation exposure. Am J Clin Nutr. 1990;52:52–58.
    1. Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001;33:1126–1141. doi: 10.1097/00005768-200107000-00010.
    1. Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985;10:141–146.
    1. Jacobs DR, Jr, Ainsworth BE, Hartman TJ, Leon AS. A simultaneous evaluation of 10 commonly used physical activity questionnaires. Med Sci Sports Exerc. 1993;25:81–91. doi: 10.1249/00005768-199301000-00012.
    1. Ware JE, New England Medical Center Hospital . Health I: SF-36 Physical and Mental Health Summary Scales: A User’s Manual. Boston: The Health Institute, New England Medical Center; 1994.
    1. Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction with Life Scale. J Pers Assess. 1985;49:71–75. doi: 10.1207/s15327752jpa4901_13.
    1. Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997;50:920–928. doi: 10.1016/S0090-4295(97)00459-7.
    1. Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987;30:191–197. doi: 10.1016/0304-3959(87)91074-8.
    1. Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999;85:1186–1196. doi: 10.1002/(SICI)1097-0142(19990301)85:5<1186::AID-CNCR24>;2-N.
    1. Expert Panel on Detection Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III) JAMA. 2001;285:2486–2497. doi: 10.1001/jama.285.19.2486.
    1. World Cancer Research Fund . Food, Nutrition and the Prevention of Cancer: A Global Perspective. Washington, DC: American Institute for Cancer Research; 2007.
    1. Felson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. Arthritis Rheum. 1987;30:914–918. doi: 10.1002/art.1780300811.
    1. Davis MA, Ettinger WH, Neuhaus JM. Obesity and osteoarthritis of the knee: evidence from the National Health and Nutrition Examination Survey (NHANES I) Semin Arthritis Rheum. 1990;20:34–41. doi: 10.1016/0049-0172(90)90045-H.

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