Development and evaluation of a training intervention for cancer teams talking about randomised trials
| ISRCTN | ISRCTN08988781 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08988781 |
| Protocol serial number | 4205 |
| Sponsor | Brighton and Sussex Medical School (UK) |
| Funder | Cancer Research UK (CRUK) (UK) |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 24/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Valerie Jenkins
Scientific
Scientific
Brighton and Sussex Medical School
University of Sussex, Biology Building
Falmer
Brighton
BN1 9QG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional multicentre process of care trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre randomised controlled trial to improve communication with patients about clinical trials within cancer teams |
| Study acronym | Teams Talking Trials |
| Study objectives | 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(s) | South East Wales Research Ethics Committee Panel C on 16/02/2007 (ref: 07/WSEO3/17) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Numbers of patients approached about trials, analysed in Jan 2011 |
| Key secondary outcome measure(s) |
Attitudes and involvement of team members, analysed in June 2010 |
| Completion date | 30/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1600 |
| Key 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 |
| Key exclusion criteria | Cancer teams in other parts of the UK |
| Date of first enrolment | 04/06/2007 |
| Date of final enrolment | 30/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton and Sussex Medical School
Brighton
BN1 9QG
United Kingdom
BN1 9QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 24/01/2022 | No | Yes |
Editorial Notes
24/01/2022: A link to plain English results was added.
