Information and communication in the context of a clinical trial

Eur J Cancer. 2000 Oct;36(16):2096-104. doi: 10.1016/s0959-8049(00)00191-x.

Abstract

The aim of this study was to determine the communicative needs of the patients in the context of being invited to participate in a clinical trial. A questionnaire was sent to 299 patients with breast cancer randomised in a trial of adjuvant therapy. It was returned by 261 (87%) of them. Ninety-one per cent (231/255) of the patients regarded the information provided as easy or quite easy to understand. However, the method of treatment allocation was unclear to most patients: 51% (128/251) thought that the doctor had chosen the treatment while only 23% (57/251) knew that they had been randomised. Younger and better educated patients had a better understanding. For 55% (125/226) of the patients written information had been helpful in decision making. This correlated highly with the education of the patient. Sixty-eight per cent (174/255) of the patients thought that they had enough time for decision-making. Less educated patients and older patients had needed more time. Eighty-seven per cent (218/251) were happy with their decision to participate. While most patients are satisfied with the information received, there is a poor understanding of how treatment is allocated. Information should be modified for older and less-educated patients. The needs of the patients when offered participation in a clinical trial are clear information, enough time to consider the options and psychological support.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Awareness
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / psychology
  • Chemotherapy, Adjuvant / methods*
  • Chemotherapy, Adjuvant / psychology
  • Communication*
  • Decision Making
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Patient Education as Topic / methods
  • Patient Participation
  • Patient Satisfaction*
  • Physician-Patient Relations*
  • Randomized Controlled Trials as Topic / standards*
  • Surveys and Questionnaires