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Clinical trial question prompt list.

Enhancing cancer patient participation when discussing clinical trial enrolment: evaluation of a question prompt list.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000214538
Enrollment
150
Registered
2006-05-31
Start date
2006-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Provision and use of a question prompt list by patients during a consultation increases question asking, reduces anxiety and improves recall. Previous work on question prompt sheets has found that when patients ask more questions, they gain a better understanding of the topic and satisfied with their treatment decisions. Medical staff also tend to be more satisfied with the consent process when patient’s display a better understanding of the discussion. A Question Prompt List has been developed for patients to facilitate patient participation in clinical trial consent discussions. This project aims to examine patient attitudes to clinical trials and to investigate the effects of promoting question asking when people with cancer are asked to consider entering a randomised clinical trial. The question prompt list will be evaluated by comparing results for the control and intervention groups on understanding of clinical trial information, satisfaction with the consent process and decision-making about trial participation and achievement of their information and involvement preference. It is expected that those patients receiving the question prompt list will have a higher mean knowledge score in the informed consent questionnaire, have enhanced achievement of their information and involvement preference and be more satisfied with the informed consent and the decision making process.

Interventions

Patients will be randomised to receive a question prompt list to use when discussing clinical trial participation with their treating clinician. The Question Prompt List is a series of example questions that patients might like to ask, to gain a better understanding of the clinical trial and help them make an informed decision about participating. Those patients who receive the list will be given a few minutes to review its content.

Patients will be randomised to receive a question prompt list to use when discussing clinical trial participation with their treating clinician. The Question Prompt List is a series of example questions that patients might like to ask, to gain a better understanding of the clinical trial and help them make an informed decision about participating. Those patients who receive the list will be given a few minutes to review its content. Both the patient and the clinician will then refer to it during their discussion about participating in a clinical trial.

Sponsors

Royal Prince Alfred Hospital, Peter MacCallum Cancer Centre, Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Confirmed diagnosis of cancer (any type), who are eligible to be invited to take part in Phase 3 randomised cancer clinical trial at Peter MacCallum Cancer Centre, can read/speak English.

Exclusion criteria

Psychological/cognitive disorder, too sick as advised by treating doctor.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026