RAW Study Version 3.4
Recruitment status was: Not yet recruiting
|First Received Date ICMJE||January 20, 2006|
|Last Updated Date||January 20, 2006|
|Start Date ICMJE||January 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||RAW Study Version 3.4|
|Official Title ICMJE||Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.|
The purpose of this study is to investigate the feasibility of carrying out a full scale randomised controlled trial to compare the effects of giving additional information versus no additional information to patients prior to their first oncology appointment.
Hypothesis: Patients with some awareness of research provided prior to clinic appointment in oncology and aware of the possibility of being invited to take part in a clinical trial are more likely to agree to participate.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Educational/Counseling/Training
|Intervention ICMJE||Behavioral: patient information leaflet|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Completion Date||November 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00280722|
|Other Study ID Numbers ICMJE||4858|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Oxford University Hospitals NHS Trust|
|Information Provided By||Oxford University Hospitals NHS Trust|
|Verification Date||January 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP