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BMJ Open. 2013 May 02;3(5). doi: 10.1136/bmjopen-2012-002266.

INvolvement of breast CAncer patients during oncological consultations: a multicentre randomised controlled trial--the INCA study protocol.

BMJ open

Claudia Goss, Alberto Ghilardi, Giuseppe Deledda, Chiara Buizza, Alessandro Bottacini, Lidia Del Piccolo, Michela Rimondini, Federica Chiodera, Maria Angela Mazzi, Mario Ballarin, Irene Bighelli, Maria Grazia Strepparava, Annamaria Molino, Elena Fiorio, Rolando Nortilli, Chiara Caliolo, Serena Zuliani, Alessandra Auriemma, Federica Maspero, Edda Lucia Simoncini, Fulvio Ragni, Richard Brown, Christa Zimmermann

Affiliations

  1. Department of Public Health and Community Medicine, Section of Clinical Psychology, University of Verona, Verona, Italy.

PMID: 23645911 PMCID: PMC3646182 DOI: 10.1136/bmjopen-2012-002266

Abstract

INTRODUCTION: Studies on patient involvement show that physicians make few attempts to involve their patients who ask few questions if not facilitated. On the other hand, the patients who participate in the decision-making process show greater treatment adherence and have better health outcomes. Different methods to encourage the active participation during oncological consultation have been described; however, similar studies in Italy are lacking. The aims of the present study are to (1) assess the effects of a preconsultation intervention to increase the involvement of breast cancer patients during the consultation, and (2) explore the role of the attending companions in the information exchange during consultation.

METHODS AND ANALYSIS: All female patients with breast cancer who attend the Oncology Out-patient Services for the first time will provide an informed consent to participate in the study. They are randomly assigned to the intervention or to the control group. The intervention consists of the presentation of a list of relevant illness-related questions, called a question prompt sheet. The primary outcome measure of the efficacy of the intervention is the number of questions asked by patients during the consultation. Secondary outcomes are the involvement of the patient by the oncologist; the patient's perceived achievement of her information needs; the patient's satisfaction and ability to cope; the quality of the doctor-patient relationship in terms of patient-centeredness; and the number of questions asked by the patient's companions and their involvement during the consultation. All outcome measures are supposed to significantly increase in the intervention group.

ETHICS AND DISSEMINATION: The study was approved by the local Ethics Committee of the Hospital Trust of Verona. Study findings will be disseminated through peer-reviewed publications and conference presentations.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01510964.

Keywords: breast cancer; docotr-pateint communication; patient involvement

References

  1. Clin Psychol Psychother. 2012 May-Jun;19(3):224-34 - PubMed
  2. Soc Sci Med. 2006 Sep;63(6):1625-36 - PubMed
  3. Lancet Oncol. 2002 Jul;3(7):431-7 - PubMed
  4. Acta Psychiatr Scand. 1994 Dec;90(6):432-7 - PubMed
  5. Psychother Psychosom. 2008;77(4):219-26 - PubMed
  6. Crit Rev Oncol Hematol. 2011 Oct;80(1):145-59 - PubMed
  7. BMJ. 2010 Mar 23;340:c869 - PubMed
  8. Ann Intern Med. 2001 Apr 17;134(8):663-94 - PubMed
  9. Health Expect. 2001 Mar;4(1):58-70 - PubMed
  10. Psychooncology. 2008 Sep;17(9):857-68 - PubMed
  11. Patient Educ Couns. 2006 Nov;63(3):319-27 - PubMed
  12. Med Educ. 1988 May;22(3):231-9 - PubMed
  13. Lancet Oncol. 2002 Oct;3(10):629-37 - PubMed
  14. J Gen Intern Med. 1996 Jan;11(1):1-8 - PubMed
  15. Can J Nurs Res. 1997 Fall;29(3):21-43 - PubMed
  16. BMJ. 2000 May 6;320(7244):1220-1 - PubMed
  17. Patient Educ Couns. 2010 Jul;80(1):94-9 - PubMed
  18. Med Decis Making. 1996 Jan-Mar;16(1):58-64 - PubMed
  19. J Clin Oncol. 2002 Jan 15;20(2):503-13 - PubMed
  20. Br J Cancer. 1999 Apr;80(1-2):242-8 - PubMed
  21. Biometrics. 1996 Dec;52(4):1324-33 - PubMed
  22. Epidemiol Psichiatr Soc. 2007 Oct-Dec;16(4):339-49 - PubMed
  23. Cancer. 2011 Jan 1;117(1):218-27 - PubMed
  24. J Pain Symptom Manage. 2003 May;25(5):412-9 - PubMed
  25. Ann Oncol. 1994 Mar;5(3):199-204 - PubMed
  26. Br J Cancer. 2001 Nov 2;85(9):1273-9 - PubMed
  27. Clin Oncol (R Coll Radiol). 2006 Jun;18(5):395-400 - PubMed
  28. J Neurol Sci. 2008 Dec 15;275(1-2):86-91 - PubMed
  29. Oncologist. 2000;5(4):302-11 - PubMed
  30. J Clin Epidemiol. 1994 Jun;47(6):647-57 - PubMed
  31. Fam Pract. 1998 Apr;15(2):165-71 - PubMed
  32. J Affect Disord. 2009 Apr;114(1-3):163-73 - PubMed
  33. Stat Med. 2003 Apr 30;22(8):1317-34 - PubMed
  34. Patient Educ Couns. 2007 Jun;66(3):296-302 - PubMed
  35. Gen Hosp Psychiatry. 2004 Mar-Apr;26(2):115-20 - PubMed
  36. J Gen Intern Med. 2001 Sep;16(9):606-13 - PubMed
  37. J Clin Oncol. 1999 Jun;17(6):1727-35 - PubMed
  38. J Clin Oncol. 2007 Feb 20;25(6):715-23 - PubMed
  39. Br J Cancer. 2003 Dec 1;89(11):2069-77 - PubMed
  40. Epidemiol Psichiatr Soc. 2003 Apr-Jun;12(2):115-23 - PubMed
  41. Health Expect. 2005 Mar;8(1):34-42 - PubMed

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