Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial

Leena Tuominen, Marita Ritmala-Castrén, Pia Nikander, Siru Mäkelä, Tero Vahlberg, Helena Leino-Kilpi, Leena Tuominen, Marita Ritmala-Castrén, Pia Nikander, Siru Mäkelä, Tero Vahlberg, Helena Leino-Kilpi

Abstract

Background: Chemotherapy-induced side effects may have a negative effect on nutrition intake, thus increasing the risk of malnutrition and consequently, other serious complications for patients with cancer. The prevalence of malnutrition is common among patients with colorectal cancer. Nurse-led empowering education may have a positive effect on self-care activity in this patient group. Therefore, our purpose is to develop an empowering educational nursing intervention and test its effect on self-care activation and knowledge level among patients with colorectal cancer during chemotherapy. Secondary outcomes are quality of life and risk of malnutrition.

Methods: An interdisciplinary expert group developed a face-to-face empowering educational intervention using teach-back method. A two-arm, single-centre, superiority trial with stratified randomisation (1:1) and pre-post measures will be used to assess the effect of the intervention compared to standard care. Patients (N = 40 + 40) will be recruited in one university hospital outpatient clinic in Finland. Eligibility criteria are adult patients diagnosed with colorectal cancer starting oral fluoropyrimidine or combination chemotherapy treatment. A registered nurse experienced in oncology will deliver the intervention 2 weeks after the first chemotherapy. Outcomes are measured before intervention (M0) and after a two-month follow-up period (M1).

Discussion: This study will assess whether nurse-led empowering education using teach-back method is effective on self-care activity among patients with colorectal cancer. If the intervention has a positive effect, it may be implemented into patient education in a corresponding context.

Trial registration: ClinicalTrials.gov : NCT04160650 Registered 12 November 2019 - retrospectively registered.

Keywords: Chemotherapy; Education; Empowerment; Nutrition; Patients with colorectal cancer; Self-care; Side effect.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments

References

    1. Forman D, Ferlay J, Stewart B, Wild C. The global and regional burden of cancer. In: World Cancer Report. 2014. . Accessed 8 Dec 2019.
    1. International Agency for Research in Cancer. Colorectal cancer. 2019. . Accessed 8 Dec 2019.
    1. Malila N, Pitkäniemi J, Virtanen A. Cancer 2017. In: Finnish Cancer Register. 2019. Accessed 24 Oct 2019.
    1. National Institute for Health and Care Excellence. Colorectal cancer: diagnosis and management. 2011. . Accessed 4 Nov 2019.
    1. Tong H, Isenring E, Yates P. The prevalence of nutrition impact symptoms and their relationship to quality of life and clinical outcomes in medical oncology patients. Support Care Cancer 2009;17:83–90. , 1
    1. Hoffman AJ. Enhancing self-efficacy for optimized patient outcomes through the theory of symptom self-management. Cancer Nurs2013;36(1):E16–E26.
    1. Hébuterne X, Lemarié E, Michallet M, de Montreuil C, Schneider S, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN 2014;38(2): 196–204.
    1. Arends J, Baracos V, Bertz H, Bozzetti F, Calder PC, Deutz NEP, Erickson N, Laviano A, Lisanti MP, Lobo DN, McMillan DC, Muscaritoli M, Ockenga J, Pirlich M, Strasser F, de van der Schueren M, van Gossum A, Vaupel P, Weimann A ESPEN expert group recommendations for action against cancer related malnutrition. Clin Nutr 2017;36(5):1187–1196.
    1. Elia M. Principles of Clinical Nutrition: Contrasting the practice of nutrition in health and disease clinical nutrition. In: Stratton RJ, Lanham-New SA, Elia M, Ljungqvist O, editors. Clinical Nutrition: Blackwell Publishing Ltd. ProQuest Ebook Central; 2013. p. 1–14. . Accessed 24 Apr 2020.
    1. de Pinho N, Martucci R, Rodrigues V, D'Almeida C, Thuler L, Saunders C, et al. High prevalence of malnutrition and nutrition impact symptoms in older patients with cancer: results of a Brazilian multicenter study. Cancer. 2020;126(1):156–164. doi: 10.1002/cncr.32437.
    1. Bicakli DH, Ozveren A, Uslu R, Dalak RM, Cehreli R, Uyar M, Karabulut B, Akcicek F The effect of chemotherapy on nutritional status and weakness in geriatric gastrointestinal system cancer patients. Nutrition. 2018;47:39–42.
    1. Barret M, Malka D, Aparicio T, Dalban C, Locher C, Sabate JM, Louafi S, Mansourbakht T, Bonnetain F, Attar A, Taieb J Nutritional status affects treatment tolerability and survival in metastatic colorectal cancer patients: results of an AGEO prospective multicenter study. Oncology. 2011;81(5–6):395–402.
    1. van der Werf A, Arthey K, Hiesmayr M, Sulz I, Schindler K, Laviano A, Langius J, de van der Schueren M The determinants of reduced dietary intake in hospitalised colorectal cancer patients. Support Care Cancer. 2018;26:3039–2047. , 6
    1. Schuetz P, Fehr R, Baechli V, Geiser M, Deiss M, Gomes F, Kutz A, Tribolet P, Bregenzer T, Braun N, Hoess C, Pavlicek V, Schmid S, Bilz S, Sigrist S, Brändle M, Benz C, Henzen C, Mattmann S, Thomann R, Brand C, Rutishauser J, Aujesky D, Rodondi N, Donzé J, Stanga Z, Mueller B. Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. Lancet. 2019;393(10188):2312–2321. doi: 10.1016/S0140-6736(18)32776-4.
    1. Tu MY, Chien TW, Lin HP, Liu MY. Effects of an intervention on nutrition consultation for cancer patients. Eur J Cancer Care 2013;22(3):370–376.
    1. Ravasco P. Nutritional support in head and neck cancer: how and why? Anti-Cancer Drugs 2011;22(7):639–646.
    1. Ravasco P, Monteiro-Grillo I, Camilo M. Individualized nutrition intervention is of major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled trial of nutritional therapy. Am J Clin Nutr2012;96(6):1346–1353.
    1. Kiss NK, Krishnasamy M. The effect of nutrition intervention in lung Cancer patients undergoing chemotherapy and/or radiotherapy: a systematic review. Nutr Cancer 2014;66(1): 47–56.
    1. Zhang F, Jin Y, Qiang W. The effects of dietary advice on malnutrition in Cancer patients: a systematic review and meta-analysis. Support Care Cancer 2020;28:1579–1585. , 4
    1. Gnagnarella P, Misotti A, Santoro L, Akoumianakis D, Del Campo L, De Lorenzo F, Lombardo C, Milolidakis G, Sullivan R, McVie J Nutritional online information for cancer patients: a randomized trial of an Internet communication plus social media intervention J Canc Educ 2016; 31:472–480. , 3
    1. Lin J-X, Chen X-W, Chen Z-H, Huang X-Y, Yang J-J, Xing Y-F, Yin L-H, Xing L, Wu X-Y. A multidisciplinary team approach for nutritional interventions conducted by specialist nurses in patients with advanced colorectal cancer undergoing chemotherapy. a clinical trial. Medicine. 2017; 96:26(e7373).
    1. Park K, Choi-Kwon S. Effects of individualized nutritional education programs on the level of nutrient intake and nutritional status of colorectal cancer patients undergoing palliative chemotherapy. J Korean Acad Nurs2012;42(6): 799–809.
    1. Xie FI, Wang YQ, Peng LF, Lin FY, He YI, Jiang Z. Beneficial effect of educational and nutritional intervention on the nutritional status and compliance of gastric Cancer patients undergoing chemotherapy: a randomized trial. Nutr Cancer 2017;69(5):762–771.
    1. Tuominen L, Stolt M, Meretoja R, Leino-Kilpi H. Effectiveness of nursing interventions among patients with cancer: an overview of systematic reviews. J Clin Nurs 2019;28:2401–2419. , 13-14
    1. Richard AA, Shea K. Delineation of self-care and associated concepts. Jour Nurs Schol2011;43(3): 255–264.
    1. Leino-Kilpi H, Luoto E, Katajisto J. Elements of empowerment and MS patients. J Neurosci Nurs 1998;30: 116–123. , 2
    1. Zimmerman MA. Psychological empowerment: issues and illustrations. Am J Community Psychol. 1995;23(5):581–599. doi: 10.1007/BF02506983.
    1. Anderson RM, Funnel MM. Patient empowerment: myths and misconceptions. Patient Educ Couns 2010;79(3):277–282.
    1. Castro EM, Van Regenmortelb T, Vanhaechtd K, Sermeusd W, Van Heckef A. Patient empowerment, patient participation and patient-centeredness in hospital care: a concept analysis based on a literature review. Patient Educ Couns 2016;99:1923–1939. , 12
    1. Leino-Kilpi H. Self-care and empowerment of individuals and populations. Editorial comment. Nurs Ethics 2009;16(3): 265–266. ./10.1177/0969733009105652
    1. Vaartio-Rajalin H, Leino-Kilpi H, Iire L, Lehtonen K, Minn H. Oncologic patients’ knowledge expectations and cognitive capacities during illness trajectory: analysis of critical moments and factors. Holis Nurs Pract 2015;29:232–244. , 4
    1. Kotronoulas G, Papadopoulou C, Burns-Cunningham K, Simpson M, Maguire R. A systematic review of the supportive care needs of people living with and beyond cancer of the colon and/or rectum. Eur J Oncol Nurs 2017;29:60–70. ./10.1016/j.ejon.2017.05.004
    1. Tuominen L, Leino-Kilpi H, Meretoja R. Expectations of patients with colorectal cancer towards nursing care– a thematic analysis. Eur J Oncol Nurs 2020. , 44, 101699
    1. Feo R, Hons B, Conroy T, Janglnand E, Muntlin Å, Brovall M, et al. Towards a standardised definition for fundamental care: a modified Delphi study. J Clin Nurs 2017;27:2285–2299. , 11-12
    1. Hibbard J, Stockard J, Mahoney E, Tusler M. Development of the patient activation measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4p1):1005–1026. doi: 10.1111/j.1475-6773.2004.00269.x.
    1. Schillinger, D., Piette, J., Grumbach, K., Wang, F., Wilson, C., Daher, C., Leong-Grotz, K.,Castro, C. & Bindman, A. 2003. Closing the loop. Physician communication with diabetic patients who have a low health literacy. Arch Intern Med;2003;163(1): 83–90.
    1. Ha Dinh TT, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Database Syst Rev Implement Rep2016;14(1):210–247.
    1. Virtanen H, Leino-Kilpi H, Salanterä S. Empowering discourse in patient education. Pat Educ Couns. 2007;66:140–146. , 2
    1. Chan, AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. , jan08 15
    1. Greene J, Hibbard JH. Why does patient activation matter? An examination of the relationships between patient activation and health-related outcomes. J Gen Intern Med 2012;27(5):520–526.
    1. Hibbard J, Mahoney E, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Research and Educational Trust 2005;40:1918–1930. , 6p1
    1. Pekonen A, Eloranta S, Stolt M, Virolainen P, Leino-Kilpi H. Measuring patient empowerment – a systematic review. Pat Educ Couns2020; 103:777–787. , 4
    1. Hibbard JH, Tusler M. Assessing activation stage and employing a “next steps” approach to supporting patient self-management. J Ambulatory Care Manage 2007;30(1):2–8.
    1. Hibbard JH, Greene J, Tusler M. Improving the outcomes of disease management by tailoring care to the patient’s level of activation. Am J Manag Care. 2009;15(6):353–360.
    1. Kesänen J, Leino-Kilpi H, Arifulla D, Siekkinen M, Valkeapää K. Knowledge tests in patient education: a systematic review. Nurs Health Sci 2014;16:262–273. , 2
    1. Calderon C, Carmona-Bayonas A, Beato C, Ghanem I, Hernandez R, Majem M, Rosa Diaz A., Higuera O., Mut Lloret M., Jimenez-Fonseca P. Risk of malnutrition and emotional distress as factors affecting health-related quality of life in patients with resected cancer. Clin Transl Oncol 2019;21(5):687–691.
    1. Cella D, Tulsky D, Gray G, Saraflan B, Linn E, Bonomi A et al The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol1993;11:570–579. , 3
    1. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the functional assessment of Cancer therapy-colorectal (FACT-C) quality of life instrument. Qual Life Res 1999;8:181–195. , 3
    1. Ganesh V, Agarwal A, Popovic M, Cella D, McDonald R, Vuong S, Lam H, Rowbottom L, Chan S, Barakat T, DeAngelis C, Borean M, Chow E, Bottomley A Comparison of the FACT-C, EORTC QLQ-CR38, and QLQ-CR29 quality of life questionnaires for patients with colorectal cancer: a literature review. Support Care Cancer2016;24:3661–3668. , 8
    1. Goździewicz B, Strugała M, Talarska D, Stanisławska J, Bączyk G. Functioning of people with colorectal cancer during chemotherapy. Demographic and clinical determinants of quality of life of patients with colorectal cancer receiving chemotherapy. Pilot stufy. Eur J Cancer Care. 2017;26(3):e12616.
    1. Cederholm T, Jensen G, Correia M, Gonzalez M, Fukushima R, Higashicuchi T, et al. GLIM criteria for the diagnosis of malnutrition e a consensus report from the global clinical nutrition community. Clin Nutr 2019; 38:1–9. , 1
    1. Kondrup J, Rasmussen H, Hamberg O, Stanga Z, ESPEN working group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr 2003;22(3):321–336.
    1. Kondrup J, Allison SP, Elia M, Vellas B, Plauth M. ESPENGuidelines for nutrition screening 2002. Clin Nutr 2003;22(4): 415–421.
    1. Snow G. Randomization for block random clinical trials. R package version 1.3. 2013. . Accessed 21 Nov 2019.
    1. R Core Team . A language and environment for statistical computing. Austria: R Foundation for Statistical Computing; 2019.
    1. Dettori J. 2010. The random allocation process: two things you need to know. Evid Based Spine Care J 2010;1: 7–9. , 03

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