A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials
Open Access
- 11 September 2007
- journal article
- research article
- Published by Springer Science and Business Media LLC in British Journal of Cancer
- Vol. 97 (6), 705-711
- https://doi.org/10.1038/sj.bjc.6603943
Abstract
Recruitment to cancer clinical trials needs to be improved, as does patient knowledge and understanding about clinical trials, in order for patients to make an informed choice about whether or not to take part. Audiovisual patient information (AVPI) has been shown to improve knowledge and understanding in various areas of practice, but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to consent rates. In this study, 173 patients were randomised to receive either the AVPI, in addition to the standard trial-specific written information, or the written information alone. There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55–2.58, P=0.661). Knowledge scores increased more in the AVPI group compared to the standard group (P=0.0072). The change in anxiety score between the arms was also statistically significant (P=0.011) with anxiety improving in the intervention arm more than in the no intervention arm. Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety, but further work is necessary in relation to its effect on clinical trial recruitment rates.Keywords
This publication has 27 references indexed in Scilit:
- The process of developing audiovisual patient information: challenges and opportunitiesJournal of Clinical Nursing, 2007
- Patient understanding of research: developing and testing of a new questionnaireEuropean Journal of Cancer Care, 2007
- The Role of Physician Characteristics in Clinical Trial Acceptance: Testing Pathways of InfluenceJournal of Health Communication, 2006
- Differences in attitudes between patients with primary colorectal cancer and patients with secondary colorectal cancer: is it reflected in their willingness to participate in drug trials?European Journal of Cancer Care, 2005
- A Videotape Intervention to Enhance the Informed Consent Process for Medical and Psychiatric Treatment ResearchAmerican Journal of Psychiatry, 2005
- The use of video information in obtaining consent for female sterilisation: a randomised studyBJOG: An International Journal of Obstetrics and Gynaecology, 2003
- “Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trialSocial Science & Medicine, 2002
- Forewarned is forearmed — benefits of preparatory information on video cassette for patients receiving chemotherapy or radiotherapy — a randomised controlled trialEuropean Journal Of Cancer, 2000
- Evaluating the benefits of a patient information video during the informed consent processPatient Education and Counseling, 1997
- Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.BMJ, 1986