Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial

Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes, Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes

Abstract

Background: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care.

Objective: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer.

Methods: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures.

Results: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service.

Conclusions: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden.

Trial registration: ClinicalTrials.gov NCT03819595; https://ichgcp.net/clinical-trials-registry/NCT03819595.

International registered report identifier (irrid): DERR1-10.2196/24835.

Keywords: behavioral change; overall survival; patients with cancer; physical activity; primary care; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.08.2021.

Figures

Figure 1
Figure 1
Schematic overview of the process for program implementation and evaluation.
Figure 2
Figure 2
Bizi Orain exercise program. M1: Low-to-moderate intensity; M2: moderate intensity; M3: intensive moderate intensity; WUp: warm up.

References

    1. Cáncer, tú decides. Las cifras del cáncer en España 2020. 2020. [2021-05-20]. .
    1. Miller KD, Nogueira L, Mariotto AB, Rowland JH, Yabroff KR, Alfano CM, Jemal A, Kramer JL, Siegel RL. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019 Sep;69(5):363–385. doi: 10.3322/caac.21565. doi: 10.3322/caac.21565.
    1. Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise guidelines for cancer survivors: consensus statement from international multidisciplinary roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375–2390. doi: 10.1249/MSS.0000000000002116.
    1. Clinton SK, Giovannucci EL, Hursting SD. The World Cancer Research Fund/American Institute for Cancer Research third expert report on diet, nutrition, physical activity, and cancer: impact and future directions. J Nutr. 2020 Apr;150(4):663–671. doi: 10.1093/jn/nxz268.
    1. World Cancer Report 2014. International Agency for Research on Cancer. 2014. [2020-05-18]. .
    1. Patel AV, Friedenreich CM, Moore SC, Hayes SC, Silver JK, Campbell KL, Winters-Stone K, Gerber LH, George SM, Fulton JE, Denlinger C, Morris GS, Hue T, Schmitz KH, Matthews CE. American College of Sports Medicine Roundtable Report on Physical Activity, Sedentary Behavior, and Cancer Prevention and Control. Med Sci Sports Exerc. 2019 Nov;51(11):2391–2402. doi: 10.1249/MSS.0000000000002117.
    1. Hayes SC, Newton RU, Spence RR, Galvão DA. The Exercise and Sports Science Australia position statement: exercise medicine in cancer management. J Sci Med Sport. 2019 Nov;22(11):1175–1199. doi: 10.1016/j.jsams.2019.05.003.
    1. Li T, Wei S, Shi Y, Pang S, Qin Q, Yin J, Deng Y, Chen Q, Wei S, Nie S, Liu L. The dose-response effect of physical activity on cancer mortality: findings from 71 prospective cohort studies. Br J Sports Med. 2016 Mar;50(6):339–345. doi: 10.1136/bjsports-2015-094927.
    1. Hojman P, Gehl J, Christensen JF, Pedersen BK. Molecular mechanisms linking exercise to cancer prevention and treatment. Cell Metab. 2018 Jan;27(1):10–21. doi: 10.1016/j.cmet.2017.09.015.
    1. Christensen JF, Simonsen C, Hojman P. Exercise training in cancer control and treatment. Compr Physiol. 2018 Dec;9(1):165–205. doi: 10.1002/cphy.c180016.
    1. Stene GB, Helbostad JL, Balstad TR, Riphagen II, Kaasa S, Oldervoll LM. Effect of physical exercise on muscle mass and strength in cancer patients during treatment--a systematic review. Crit Rev Oncol Hematol. 2013 Dec;88(3):573–593. doi: 10.1016/j.critrevonc.2013.07.001.
    1. Padilha CS, Marinello PC, Galvão DA, Newton RU, Borges FH, Frajacomo F, Deminice R. Evaluation of resistance training to improve muscular strength and body composition in cancer patients undergoing neoadjuvant and adjuvant therapy: a meta-analysis. J Cancer Surviv. 2017 Jun;11(3):339–349. doi: 10.1007/s11764-016-0592-x.
    1. Hardee JP, Porter RR, Sui X, Archer E, Lee I, Lavie CJ, Blair SN. The effect of resistance exercise on all-cause mortality in cancer survivors. Mayo Clin Proc. 2014 Aug;89(8):1108–1115. doi: 10.1016/j.mayocp.2014.03.018.
    1. Nadler M, Bainbridge D, Tomasone J, Cheifetz O, Juergens RA, Sussman J. Oncology care provider perspectives on exercise promotion in people with cancer: an examination of knowledge, practices, barriers, and facilitators. Support Care Cancer. 2017 Jul;25(7):2297–2304. doi: 10.1007/s00520-017-3640-9.
    1. Hardcastle SJ, Kane R, Chivers P, Hince D, Dean A, Higgs D, Cohen PA. Knowledge, attitudes, and practice of oncologists and oncology health care providers in promoting physical activity to cancer survivors: an international survey. Support Care Cancer. 2018 Nov;26(11):3711–3719. doi: 10.1007/s00520-018-4230-1.
    1. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von GVE, Schwartz AL, American COSM. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409–1426. doi: 10.1249/MSS.0b013e3181e0c112.
    1. Loprinzi PD, Lee H, Cardinal BJ. Objectively measured physical activity among US cancer survivors: considerations by weight status. J Cancer Surviv. 2013 Sep;7(3):493–499. doi: 10.1007/s11764-013-0293-7.
    1. Heston A, Schwartz AL, Justice-Gardiner H, Hohman KH. Addressing physical activity needs of survivors by developing a community-based exercise program: LIVESTRONG® at the YMCA. Clin J Oncol Nurs. 2015 Apr;19(2):213–217. doi: 10.1188/15.CJON.213-217.
    1. Cormie P, Lamb S, Newton RU, Valentine L, McKiernan S, Spry N, Joseph D, Taaffe DR, Doran CM, Galvão DA. Implementing exercise in cancer care: study protocol to evaluate a community-based exercise program for people with cancer. BMC Cancer. 2017 Feb;17(1):103. doi: 10.1186/s12885-017-3092-0.
    1. Sancho A, Carrera S, Arietaleanizbeascoa M, Arce V, Gallastegui NM, Giné March A, Sanz-Guinea A, Eskisabel A, Rodriguez AL, Martín RA, Lopez-Vivanco G, Grandes G. Supervised physical exercise to improve the quality of life of cancer patients: the EFICANCER randomised controlled trial. BMC Cancer. 2015 Feb;15:40. doi: 10.1186/s12885-015-1055-x.
    1. Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvão DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019 Nov;69(6):468–484. doi: 10.3322/caac.21579. doi: 10.3322/caac.21579.
    1. Cormie P, Lamb S, Newton RU, Valentine L, McKiernan S, Spry N, Joseph D, Taaffe DR, Doran CM, Galvão Daniel A. Implementing exercise in cancer care: study protocol to evaluate a community-based exercise program for people with cancer. BMC Cancer. 2017 Feb;17(1):103. doi: 10.1186/s12885-017-3092-0.
    1. Grandes G, Sanchez A, Cortada JM, Balague L, Calderon C, Arrazola A, Vergara I, Millan E, Prescribe Vida Saludable group Is integration of healthy lifestyle promotion into primary care feasible? Discussion and consensus sessions between clinicians and researchers. BMC Health Serv Res. 2008 Oct;8:213. doi: 10.1186/1472-6963-8-213.
    1. Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: a review of reviews. Prev Med. 2015 Jul;76 Suppl:S56–67. doi: 10.1016/j.ypmed.2014.09.012.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322–7. doi: 10.2105/ajph.89.9.1322.
    1. Hayes SC, Newton RU, Spence RR, Galvão DA. The Exercise and Sports Science Australia position statement: exercise medicine in cancer management. J Sci Med Sport. 2019 Nov;22(11):1175–1199. doi: 10.1016/j.jsams.2019.05.003.
    1. Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222–226.
    1. Bohannon RW. Alternatives for measuring knee extension strength of the elderly at home. Clin Rehabil. 1998 Oct;12(5):434–440. doi: 10.1191/026921598673062266.
    1. Simonsick EM, Fan E, Fleg JL. Estimating cardiorespiratory fitness in well-functioning older adults: treadmill validation of the long distance corridor walk. J Am Geriatr Soc. 2006 Jan;54(1):127–132. doi: 10.1111/j.1532-5415.2005.00530.x.
    1. Gil-Rey E, Quevedo-Jerez K, Maldonado-Martin S, Herrero-Román F. Exercise intensity guidelines for cancer survivors: a comparison with reference values. Int J Sports Med. 2014 Dec;35(14):e1–e9. doi: 10.1055/s-0034-1389972.
    1. Borg G, Ljunggren G, Ceci R. The increase of perceived exertion, aches and pain in the legs, heart rate and blood lactate during exercise on a bicycle ergometer. Eur J Appl Physiol Occup Physiol. 1985;54(4):343–349. doi: 10.1007/bf02337176.
    1. Kraemer W, Fleck S. Strength Training for Young Athletes. United States: Human Kinetics; 2005.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care. 1992 Jun;30(6):473–483.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de HJC. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar;85(5):365–376.
    1. Sánchez-López María del Pilar, Dresch V. The 12-Item General Health Questionnaire (GHQ-12): reliability, external validity and factor structure in the Spanish population. Psicothema. 2008 Nov;20(4):839–43.
    1. Cella D, Nowinski CJ. Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system. Arch Phys Med Rehabil. 2002 Dec;83(12 Suppl 2):S10–17. doi: 10.1053/apmr.2002.36959.
    1. Rubio Valladolid G, Bermejo Vicedo J, Caballero Sánchez-Serrano M C, Santo-Domingo Carrasco J. [Validation of the Alcohol Use Disorders Identification Test (AUDIT) in primary care] Rev Clin Esp. 1998 Jan;198(1):11–4.
    1. Kilk K, Meitern R, Härmson O, Soomets U, Hõrak P. Assessment of oxidative stress in serum by d-ROMs test. Free Radic Res. 2014 Aug;48(8):883–889. doi: 10.3109/10715762.2014.919390.
    1. Miyamoto S, Minakata Y, Azuma Y, Kawabe K, Ono H, Yanagimoto R, Suruda T. Verification of a motion sensor for evaluating physical activity in COPD patients. Can Respir J. 2018;2018:8343705. doi: 10.1155/2018/8343705. doi: 10.1155/2018/8343705.
    1. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. Oxford, England: Oxford University Press; 2015.
    1. Birken SA, Powell BJ, Presseau J, Kirk MA, Lorencatto F, Gould NJ, Shea CM, Weiner BJ, Francis JJ, Yu Y, Haines E, Damschroder LJ. Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci. 2017 Dec;12(1):2. doi: 10.1186/s13012-016-0534-z.
    1. Kelle U. "Emergence" vs. "Forcing" of empirical data? A crucial problem of "Grounded Theory" Reconsidered. Forum Qualitative Sozialforschung. 2005 May;6(2):27.
    1. Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822–829. doi: 10.1097/mss.0b013e31803349c6.
    1. Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA, European Association for Cardiovascular PreventionRehabilitation. American Association of CardiovascularPulmonary Rehabilitation. Canadian Association of Cardiac Rehabilitation Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation and the Canadian Association of Cardiac Rehabilitation. Eur J Prev Cardiol. 2013 Jun;20(3):442–467. doi: 10.1177/2047487312460484.
    1. Borg G, Ljunggren G, Ceci R. The increase of perceived exertion, aches and pain in the legs, heart rate and blood lactate during exercise on a bicycle ergometer. Eur J Appl Physiol Occup Physiol. 1985;54(4):343–349. doi: 10.1007/bf02337176.
    1. Gorostiaga EM, Navarro-Amézqueta I, Calbet JAL, Sánchez-Medina L, Cusso R, Guerrero M, Granados C, González-Izal M, Ibáñez J, Izquierdo M. Blood ammonia and lactate as markers of muscle metabolites during leg press exercise. J Strength Cond Res. 2014 Oct;28(10):2775–2785. doi: 10.1519/JSC.0000000000000496.
    1. González-Badillo JJ, Rodríguez-Rosell D, Sánchez-Medina L, Ribas J, López-López C, Mora-Custodio R, Yañez-García JM, Pareja-Blanco F. Short-term recovery following resistance exercise leading or not to failure. Int J Sports Med. 2016 Apr;37(4):295–304. doi: 10.1055/s-0035-1564254.
    1. Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991 Dec;50(2):179–211. doi: 10.1016/0749-5978(91)90020-T.
    1. Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med. 2002 May;22(4):267–84. doi: 10.1016/s0749-3797(02)00415-4.
    1. Glasgow RE, Goldstein MG, Ockene JK, Pronk NP. Translating what we have learned into practice. Principles and hypotheses for interventions addressing multiple behaviors in primary care. Am J Prev Med. 2004 Aug;27(2 Suppl):88–101. doi: 10.1016/j.amepre.2004.04.019.
    1. Mina DS, Sabiston CM, Au D, Fong AJ, Capozzi LC, Langelier D, Chasen M, Chiarotto J, Tomasone JR, Jones JM, Chang E, Culos-Reed SN. Connecting people with cancer to physical activity and exercise programs: a pathway to create accessibility and engagement. Curr Oncol. 2018 Apr;25(2):149–162. doi: 10.3747/co.25.3977.
    1. Dennett AM, Peiris CL, Shields N, Prendergast LA, Taylor NF. Moderate-intensity exercise reduces fatigue and improves mobility in cancer survivors: a systematic review and meta-regression. J Physiother. 2016 Apr;62(2):68–82. doi: 10.1016/j.jphys.2016.02.012.
    1. Heston A, Schwartz AL, Justice-Gardiner H, Hohman KH. Addressing physical activity needs of survivors by developing a community-based exercise program: LIVESTRONG® at the YMCA. Clin J Oncol Nurs. 2015 Apr;19(2):213–217. doi: 10.1188/15.CJON.213-217.

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