Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4205
Study information
Scientific title
A multicentre randomised controlled trial to improve communication with patients about clinical trials within cancer teams
Acronym
Teams Talking Trials
Study hypothesis
The study is a randomised trial to examine whether the communication with patients about clinical trials can be improved within cancer teams. The aims of the study are to:
1. Examine the attitudes of multidisciplinary team (MDT) members to clinical trials and the influence these have on trial recruitment
2. Examine the attitudes of patients towards clinical trials, and their satisfaction with and comprehension of information received about trials and conduct and evaluate specific training for cancer teams about trial discussions.
Team members who undergo focused training will:
1. Display greater confidence about trial discussions post course
2. Be clearer about the informational roles played by colleagues when discussing trials
Patients seen by teams who undergo training will:
1. Rate clarity of information provided more highly
2. Provide more positive reasons for accepting or declining trial end
Ethics approval
South East Wales Research Ethics Committee Panel C on 16/02/2007 (ref: 07/WSEO3/17)
Study design
Randomised interventional multicentre process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All
Intervention
The intervention is a 1.5 training course in communication about randomised clinical trials for cancer teams. Each team will receive the intervention either following 6 or 12 months of data collection.
Follow Up Length: 0 month(s)
Study Entry : Other
Details:
Patients attending clinics and hospitals for treatment or follow up are recruited to survey A. 50 patients for each team will be recruited into the survey A.
The number of patients for survey B will vary according to each team, and the number will be recorded pre- and post-educational intervention.
Each patient completes a survey and is noted on the accrual spreadsheet as registered, although the protocol design is randomised.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Numbers of patients approached about trials, analysed in Jan 2011
Secondary outcome measures
Attitudes and involvement of team members, analysed in June 2010
Overall trial start date
04/06/2007
Overall trial end date
30/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cancer teams working in Wales
2. Patients who have had a randomised clinical trial discussed with them by one of the team members
3. Either sex, aged 18 - 90 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1600; UK Sample Size: 1600
Participant exclusion criteria
Cancer teams in other parts of the UK
Recruitment start date
04/06/2007
Recruitment end date
30/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton and Sussex Medical School
Brighton
BN1 9QG
United Kingdom
Sponsor information
Organisation
Brighton and Sussex Medical School (UK)
Sponsor details
University of Sussex
Biology Building
Falmer
Brighton
BN1 9QG
United Kingdom
Scott.Harfield@bsuh.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23403074
Publication citations
-
Results
Jenkins VA, Farewell D, Farewell V, Batt L, Wagstaff J, Langridge C, Fallowfield LJ, , Teams Talking Trials: results of an RCT to improve the communication of cancer teams about treatment trials., Contemp Clin Trials, 2013, 35, 1, 43-51, doi: 10.1016/j.cct.2013.02.003.