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A randomised controlled trial of clinical pharmacy intervention versus standard care to improve medication adherence in outpatients with head and neck cancer receiving radiotherapy

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Abstract

Purpose

Patient understanding of medicines information and adherence to medication instructions are important variables for ensuring optimal cancer care. This randomised controlled trial (RCT) aimed to evaluate the impact of an outpatient clinical pharmacy service on medication adherence and symptom burden in cancer patients.

Methods

In this single-centre RCT, 115 patients were randomised 1:1 to a pharmacist-led pharmaceutical care program (intervention, n = 59) versus standard of care (control, n = 56) within an outpatient multidisciplinary radiotherapy clinic. The primary endpoint was medication adherence as assessed by Medication Understanding and Use Self-Efficacy (MUSE) scale and Teach-Back assessment. Secondary endpoints were patient-reported symptom burden assessed by the Edmonton Symptom Assessment Scale (ESAS). Patients were assessed at baseline (weeks 1–2) and at discharge from radiotherapy (weeks 5–7).

Results

Polypharmacy (use of five or more medications) was observed in 26% of patients at baseline compared to 97% at discharge. Patient self-efficacy and medication adherence was higher in the intervention arm compared to the control arm, with a mean MUSE score difference of 2.70 (95% CI 1.24, 4.17) after adjustment for baseline, and a higher proportion of patients with average Teach-Back score of four or more (86% vs 14%; odds ratio (OR) 46.09, 95% CI 14.49, 146.56). The mean (SD) scores for aggregate ESAS (0–100) at discharge were 26.2 (14.0) in the intervention arm and 32.0 (15.8) in the control arm demonstrating lower overall symptom burden associated with the intervention (mean score difference adjusted for baseline − 0.52; 95% CI − 1.03, − 0.01).

Conclusion

A structured outpatient clinic pharmacy service significantly improved medication adherence and reduced overall symptom burden in patients receiving radiotherapy.

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References

  1. Australian Institute of Health and Welfare (2017). Cancer in Australia Canberra: AIHW

  2. Townsend M, Kallogjeri D, Scott-Wittenborn N, Gerull K, Jansen S, Nussenbaum B (2017) Multidisciplinary clinic management of head and neck cancer. JAMA Otolaryngol Head Neck Surg 143(12):1213–1219

    Article  Google Scholar 

  3. Chin D, Boyle GM, Porceddu S, Theile DR, Parsons PG, Coman WB (2006) Head and neck cancer: past, present and future. Expert Rev Anticancer Ther 6(7):1111–1118

    Article  Google Scholar 

  4. Blanco AI, Chao KS, El Naqa I, Franklin GE, Zakarian K, Vicic M et al (2005) Dose-volume modeling of salivary function in patients with head-and-neck cancer receiving radiotherapy. Int J Radiat Oncol Biol Phys 62(4):1055–1069

    Article  Google Scholar 

  5. Epstein JB, Hong C, Logan RM, Barasch A, Gordon SM, Oberlee-Edwards L et al (2010) A systematic review of orofacial pain in patients receiving cancer therapy. Support Care Cancer 18(8):1023–1031

    Article  Google Scholar 

  6. Sroussi HY, Epstein JB, Bensadoun R-J, Saunders DP, Lalla RV, Migliorati CA et al (2017) Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med 6(12):2918–2931

    Article  Google Scholar 

  7. Kawashita Y, Soutome S, Umeda M, Saito T (2020) Oral management strategies for radiotherapy of head and neck cancer. Jpn Dent Sci Rev 56(1):62–67

    Article  Google Scholar 

  8. Brown MT, Bussell JK (2011) Medication adherence: WHO cares? Mayo Clin Proc 86(4):304–314

    Article  Google Scholar 

  9. Sabaté E e, ed. Adherence to long-term therapies: evidence for action. Geneva, Switzerland: World Health Organization;. 2003.

  10. Lees J, Chan A (2011) Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol 12(13):1249–1257

    Article  Google Scholar 

  11. Du XL, Liu CC (2010) Racial/Ethnic disparities in socioeconomic status, diagnosis, treatment and survival among medicare-insured men and women with head and neck cancer. J Health Care Poor Underserved 21(3):913–930

    Article  Google Scholar 

  12. Maleki S, Alexander M, Liu C, Rischin D, Lingaratnam S, Fua T. Radiation oncology outpatient medication management needs and service gaps — a cross-sectional study of patients and clinicians. J Oncol Pharm Pract 2019:107815521987521.

  13. Kris MG, Gaspar LE, Chaft JE, Kennedy EB, Azzoli CG, Ellis PM et al (2017) Adjuvant systemic therapy and adjuvant radiation therapy for stage I to IIIA completely resected non-small-cell lung cancers: American Society of Clinical Oncology/Cancer Care Ontario Clinical Practice Guideline Update. J Clin Oncol Off J Am Soc Clin Oncol 35(25):2960–2974

    Article  Google Scholar 

  14. Maleki S, Alexander M, Fua T, Liu C, Rischin D, Lingaratnam S (2018) A systematic review of the impact of outpatient clinical pharmacy services on medication-related outcomes in patients receiving anticancer therapies. J Oncol Pharm Pract 25:107815521878381

    Google Scholar 

  15. Cameron KA, Ross EL, Clayman ML, Bergeron AR, Federman AD, Bailey SC et al (2010) Measuring patients’ self-efficacy in understanding and using prescription medication. Patient Educ Couns 80(3):372–376

    Article  Google Scholar 

  16. Use the Teach-Back Method: Tool #5. Agency for Healthcare Research and Quality, Rockville, MD. Content last reviewed February 2015

  17. Yen PH, Leasure AR (2019) Use and effectiveness of the teach-back method in patient education and health outcomes. Fed Pract 36(6):284–289

    PubMed  PubMed Central  Google Scholar 

  18. Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K (1991) The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 7(2):6–9

    Article  CAS  Google Scholar 

  19. Patient-reported measures (PRMs). NSW Agency for Clinical Innovation. Cited 20 February 2018;Accessed online: www.aci.health.nsw.gov.au. .

  20. Hui D, Bruera E (2017) The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments. J Pain Symptom Manage 53(3):630–643

    Article  Google Scholar 

  21. Lamarche L, Tejpal A, Mangin D. Self-efficacy for medication management: a systematic review of instruments. (1177–889X (Print)).

  22. Davis TC, Wolf MS, Bass PF 3rd, Thompson JA, Tilson HH, Neuberger M et al (2006) Literacy and misunderstanding prescription drug labels. Ann Intern Med 145(12):887–894

    Article  Google Scholar 

  23. Schillinger D, Piette J, Grumbach K, Wang F, Wilson C, Daher C et al (2003) Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med 163(1):83–90

    Article  Google Scholar 

  24. Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V et al (1998) Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med 338(25):1798–1804

    Article  CAS  Google Scholar 

  25. Chao KS, Deasy JO, Markman J, Haynie J, Perez CA, Purdy JA et al (2001) A prospective study of salivary function sparing in patients with head-and-neck cancers receiving intensity-modulated or three-dimensional radiation therapy: initial results. Int J Radiat Oncol Biol Phys 49(4):907–916

    Article  CAS  Google Scholar 

  26. Elting LS, Cooksley CD, Chambers MS, Garden AS (2007) Risk, outcomes, and costs of radiation-induced oral mucositis among patients with head-and-neck malignancies. Int J Radiat Oncol Biol Phys 68(4):1110–1120

    Article  Google Scholar 

  27. Masnoon N, Shakib S, Kalisch-Ellett L, Caughey GE. What is polypharmacy? A systematic review of definitions. BMC Geriatr. 2017;17(1):230-.

  28. Rieckert A, Trampisch US, Klaaßen-Mielke R, Drewelow E, Esmail A, Johansson T, et al. Polypharmacy in older patients with chronic diseases: a cross-sectional analysis of factors associated with excessive polypharmacy. BMC Fam Pract. 2018;19(1):113-.

  29. Drzayich Antol D, Waldman Casebeer A, Khoury R, Michael T, Renda A, Hopson S et al (2018) The relationship between comorbidity medication adherence and health related quality of life among patients with cancer. J Patient-Rep Outcomes 2(1):29

    Article  Google Scholar 

  30. Waddle MR, Chen RC, Arastu NH, Green RL, Jackson M, Qaqish BF et al (2015) Unanticipated hospital admissions during or soon after radiation therapy: Incidence and predictive factors. Pract Radiat Oncol 5(3):e245–e253

    Article  Google Scholar 

  31. Würdemann N, Wagner S, Sharma SJ, Prigge E-S, Reuschenbach M, Gattenlöhner S, et al. Prognostic Impact of AJCC/UICC 8th Edition New Staging Rules in Oropharyngeal Squamous Cell Carcinoma. Front Oncol. 2017;7:129-.

  32. Kobayashi K, Hisamatsu K, Suzui N, Hara A, Tomita H, Miyazaki T (2018) A Review of HPV-Related Head and Neck Cancer. J Clin Med 7(9):241

    Article  CAS  Google Scholar 

  33. Lamarche L, Tejpal A, Mangin D (2018) Self-efficacy for medication management: a systematic review of instruments. Patient Prefer Adherence 12:1279–1287

    Article  Google Scholar 

  34. Puts MTE, Tu HA, Tourangeau A, Howell D, Fitch M, Springall E et al (2014) Factors influencing adherence to cancer treatment in older adults with cancer: a systematic review. Ann Oncol 25(3):564–577

    Article  CAS  Google Scholar 

  35. Lo Nigro C, Denaro N, Merlotti A, Merlano M (2017) Head and neck cancer: improving outcomes with a multidisciplinary approach. Cancer Manag Res 9:363–371

    Article  CAS  Google Scholar 

  36. Bassan F, Peter F, Houbre B, Brennstuhl MJ, Costantini M, Speyer E et al (2014) Adherence to oral antineoplastic agents by cancer patients: definition and literature review. Eur J Cancer Care 23(1):22–35

    Article  CAS  Google Scholar 

  37. Puts MT, Costa-Lima B, Monette J, Girre V, Wolfson C, Batist G et al (2009) Medication problems in older, newly diagnosed cancer patients in Canada: how common are they? A prospective pilot study. Drugs Aging 26(6):519–536

    Article  Google Scholar 

  38. Nekhlyudov L, Lacchetti C, Davis NB, Garvey TQ, Goldstein DP, Nunnink JC et al (2017) Head and neck cancer survivorship care guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Cancer Society Guideline. J Clin Oncol Off J Am Soc Clin Oncol 35(14):1606–1621

    Article  Google Scholar 

  39. Watanabe SM, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F (2011) A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage 41(2):456–468

    Article  Google Scholar 

  40. Davis TC, Federman AD, Bass PF 3rd, Jackson RH, Middlebrooks M, Parker RM et al (2009) Improving patient understanding of prescription drug label instructions. J Gen Intern Med 24(1):57–62

    Article  Google Scholar 

  41. Davis TC, Wolf MS, Bass PF, Middlebrooks M, Kennen E, Baker DW et al (2006) Low literacy impairs comprehension of prescription drug warning labels. J Gen Intern Med 21(8):847–851

    Article  Google Scholar 

  42. Wolf MS, Davis TC, Tilson HH, Bass PF 3rd, Parker RM (2006) Misunderstanding of prescription drug warning labels among patients with low literacy. Am J Health Sys Pharm AJHP: Off J Am Soc Health Sys Pharm 63(11):1048–1055

    Article  Google Scholar 

  43. Bansal A, Singh MP, Rai B (2016) Human papillomavirus-associated cancers: a growing global problem. Int J Appl Basic Med Res 6(2):84–89

    Article  CAS  Google Scholar 

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Funding

This work was funded by the Western and Central Melbourne Integrated Cancer Services (WCMICS).

Author information

Authors and Affiliations

  1. Department of Pharmacy, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia

    Sam Maleki, Sarah Glewis, Marliese Alexander & Senthil Lingaratnam

  2. Department of Radiation Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia

    Tsien Fua & Chen Liu

  3. Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia

    Danny Rischin

  4. Department of Oncology, Sir Peter MacCallum, University of Melbourne, Grattan St, Parkville Victoria, 3010, Australia

    Danny Rischin & Marliese Alexander

  5. Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia

    Lumine Na

Authors
  1. Sam Maleki
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  2. Sarah Glewis
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  3. Tsien Fua
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  4. Chen Liu
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  5. Danny Rischin
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  6. Marliese Alexander
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  7. Lumine Na
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  8. Senthil Lingaratnam
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Contributions

All authors were involved in the design and set-up of the study, analysis of results, and authorship of manuscript; Sam Maleki and Sarah Glewis were also involved in collection of data; Lumine Na was involved in statistical analysis.

Corresponding author

Correspondence to Sam Maleki.

Ethics declarations

Ethics approval

Approval from the institutional ethical review committee was obtained ahead of the study commencement (Research Number LNR/17/PMCC/184).

Consent to participate

All patients provided written informed consent to participate in the study.

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All patients provided written informed consent for publication of the study.

Conflict of interest

The authors declare no competing interests.

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Maleki, S., Glewis, S., Fua, T. et al. A randomised controlled trial of clinical pharmacy intervention versus standard care to improve medication adherence in outpatients with head and neck cancer receiving radiotherapy. Support Care Cancer 30, 4243–4253 (2022). https://doi.org/10.1007/s00520-021-06779-5

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  • DOI: https://doi.org/10.1007/s00520-021-06779-5

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