Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.
The recruitment of cancer patients into clinical trials may be hindered by several factors
such as limited understanding of medical research, a lack of information about the type of
research on offer for patients, over load of information when given a new and life limiting
diagnosis. Nor does the Churchill Hospital inform patients that research is an integral part
of the every day life and business of the hospital.
Does increasing research awareness impact on accrual?
This initial study aims to establish the feasibility of a larger study to gather the
evidence required to investigate whether patients need some information indicating that a
hospital participates in research, and what it may mean to the individuals to participate,
including new terminology; thus reducing fear and anxiety and ultimately increasing the
accrual of cancer patients into cancer clinical trials. Prior knowledge of patients'
attitudes to involvement in clinical trials might assist communication about trials and
encourage more doctors to approach eligible patients. In the NHS there is always a fear of
cost implications, however a study comparing two New Patient Information Packs (NPIPs)
showed no differences were detected between a full pack and a mini pack and given the cost,
the mini−New Patient Information Pack (mini−NPIP) was the preferred approach. This has
influenced the decision to provide only a brief leaflet of information to patients prior to
their first appointment.
The National Cancer Research Network (NCRN) was formed three years ago with the aim to
provide the NHS infrastructure to support and improve patient care by speeding up access to
the best treatment and care, provide information and support to our patients and improve the
speed of research by increasing the number of patients into clinical trials. In the Thames
Valley Cancer Research Network (TVCRN) accrual has increased from 2.7% in 2001−2 to 8.3% in
2003−4. The infrastructure to support research is in place, clinicians are informed and have
relevant nursing and administrative support to offer trials to patients and cope with the
increased numbers of patients taking part. There appears to be a deficit in the research
knowledge and understanding of the general public. It is easier and less stressful to 'opt
out' when faced with a new diagnosis and complicated treatment options than to consider, in
addition, a clinical trial. By measuring accrual and evaluating the patients' response to
information about research I intend to investigate the feasibility of a larger study to
provide the evidence to investigate the need for pre−first−visit research information. Thus
investigating the requirement, importance and need for information for the patients before
their first oncology appointment and the general public.
Ellis, Buttow and Tattersall have published two studies conducted with breast cancer
patients: the first in 2001 found that that women who have a better knowledge of clinical
trials are more willing to consider participating in a clinical trial, however in 2002
patients who had received a booklet of information about research for patients were
significantly less likely to consider participating in a randomised clinical trial (RCT).
Using a very large sample (n=2331) Jenkins, Fallowfield and Saul showed that the vast
majority of cancer patients questioned wanted a great deal of specific information
concerning their illness and treatment.
Allocation: Randomized, Primary Purpose: Educational/Counseling/Training
Whether it is feasible to carry out a full scale randomised controlled trial to compare the effect of giving additional information versus no additional information to patients prior to their first oncology appointment.
Susan J Palmer
Thames Valley Cancer Research Network
United Kingdom: Medicines and Healthcare Products Regulatory Agency