Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials

Martin H N Tattersall, Michael Jefford, Andrew Martin, Ian Olver, John F Thompson, Richard F Brown, Phyllis N Butow, Martin H N Tattersall, Michael Jefford, Andrew Martin, Ian Olver, John F Thompson, Richard F Brown, Phyllis N Butow

Abstract

Objective: To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials.

Setting: Tertiary cancer referral hospitals in three state capital cities in Australia.

Participants: 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial.

Interventions: We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial.

Primary and secondary outcomes: Questionnaires were completed at baseline and within 3 weeks of deciding on treatment trial participation.

Main outcome measure: scores on the Quality of Informed Consent questionnaire (QuIC).

Results: 88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups.

Conclusions: Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006.

Trial registration number: Results, ACTRN12606000214538.

Keywords: Informed Consent Questionnaire; Question Prompt List.

Conflict of interest statement

Competing interests: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Questions you may wish to ask your doctor about clinical trials. This question prompt list is intended to help you to make a decision about participating in a cancer clinical trial. It provides you with some questions that you might like to think about and ask your doctor now or later.
Figure 2
Figure 2
Participant flow diagram.

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