Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Valerie Jenkins

ORCID ID

Contact details

Brighton and Sussex Medical School
University of Sussex
Biology Building
Falmer
Brighton
BN1 9QG
United Kingdom

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 measures

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

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

http://www.bsuh.nhs.uk

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23403074

Publication citations

  1. 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.

Additional files

Editorial Notes