Helping senior doctors involved in cancer care improve their ability to break bad news, elicit and respond to patients' concerns

ISRCTN	ISRCTN65481287
DOI	https://doi.org/10.1186/ISRCTN65481287
Protocol serial number	N0063044242
Sponsor	Department of Health
Funder	Christie Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof P M Maguire
Scientific

CRC Psychological Medicine Group
Stanley House Christie NHS Trust
Wilmslow Road
Withington
Manchester
M20 4BX
United Kingdom

Phone	+44 (0)161 446 3680

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	To determine if training consultants and senior registrars specialising in cancer in breaking bad news, eliciting and responding to patients' concerns.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	NHS Doctors
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/1997
Date of final enrolment	31/12/2008

CRC Psychological Medicine Group

Manchester
M20 4BX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes