RAW Study Version 3.4

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Oxford University Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Liverpool John Moores University
National Cancer Research Network
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00280722
First received: January 20, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Cancer
Behavioral: patient information leaflet

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Educational/Counseling/Training
Official Title: Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Whether existing and/or acquired research awareness may influence participation.
  • Development of the research information leaflet.
  • Development, testing and validation of the data collection methods.
  • Number of questionnaires returned.
  • Realistic data for estimating sample sizes in the larger study.

Estimated Enrollment: 400
Study Start Date: January 2006
Estimated Study Completion Date: November 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient requiring first oncology appointment whose appointments are being planned more than 3 days in advance. (see exclusion criteria for reason)
  2. 18 years or over. (The project will take place in adult clinic − all children & young people under 18 are seen and cared for in the paediatric unit.) -

Exclusion Criteria:

  1. New patient referrals whose appointments are being planned in less than 3 days are often telephoned with details and will not have sufficient time to receive the information by post and read it prior to their appointment.
  2. Vulnerable patients under 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280722

Contacts
Contact: Susan J Palmer 01865857158 susan.palmer@orh.nhs.uk

Locations
United Kingdom
Churchill Hospital Not yet recruiting
Oxford, United Kingdom, OX3 7LJ
Contact: Susan J Palmer    01865857158    susan.palmer@orh.nhs.uk   
Contact: Sarah Palmer    01865857158      
Principal Investigator: Susan J Palmer         
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Liverpool John Moores University
National Cancer Research Network
Investigators
Principal Investigator: Susan J Palmer Thames Valley Cancer Research Network
  More Information

Publications:
Harrison J. Why it is preferable to learn before the moment of diagnosis. In: Marie Curie Cancer Care in association with the Consumers’ Advisory Group for Clinical Trials (CAG-CT) Conference: Towards Public Understanding of Clinical Trials, 16 Feb 1998, London.

ClinicalTrials.gov Identifier: NCT00280722     History of Changes
Other Study ID Numbers: 4858
Study First Received: January 20, 2006
Last Updated: January 20, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Oxford University Hospitals NHS Trust:
Randomised
Intervention
Leaflet
Information
Awareness
Behaviour
Research

ClinicalTrials.gov processed this record on October 01, 2014