Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof P M Maguire

ORCID ID

Contact details

CRC Psychological Medicine Group
Stanley House Christie NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 (0)161 446 3680

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063044242

Study information

Scientific title

Acronym

Study hypothesis

To determine if training consultants and senior registrars specialising in cancer in breaking bad news, eliciting and responding to patients' concerns.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Miscellaneous cancers

Intervention

Randomised controlled trial of training consultants and senior registrars specialising in cancer in breaking bad news, eliciting and responding to patients' concerns.
Arm A = Training, Arm B = without Training.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Doctors: Objective ratings of recorded interviews with 2 simulated patients before training, after training and 3 months later. Objective ratings via radiomicrophone recordings of 10 consultations when breaking bad news before and after training. Subjective: Maslach Burnout Inventory, self efficacy, outcome expectancy before and after training and 3 months later.

Patients:
1. Pre-consultation: Hospital Anxiety and Depression Scale (HADS), Spielberger state anxiety
2. Post-consultation: Spielberger, concerns checklist
3. 1 and 3 months later: concerns checklist and HADS by post

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1997

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

NHS Doctors

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/1997

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CRC Psychological Medicine Group
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Christie Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes