Advance care planning in advanced cancer - can it be achieved? A patient preference trial of a care planning discussion

ISRCTN	ISRCTN27270911
DOI	https://doi.org/10.1186/ISRCTN27270911
Secondary identifying numbers	N/A

Submission date: 08/01/2007
Registration date: 16/02/2007
Last edited: 29/03/2022

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

Not provided at time of registration

Contact information

Dr Louise Jones
Scientific

Marie Curie Palliative Care Research Unit
Royal Free and University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Email	l.jones@medsch.ucl.ac.uk

Study information

Study design	Randomised controlled patient preference trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Advance care planning in advanced cancer - can it be achieved? A patient preference trial of a care planning discussion
Study objectives	1. What is the acceptability and feasibility of a patient preference randomised controlled trial of an intervention to facilitate planning for end-of-life care? 2. Which outcomes are appropriate and measurable to assess the effectiveness of this intervention?
Ethics approval(s)	Royal Free Hospital and Medical School Local Research Ethics Committee. Approved on 17.08.06, ref 06/Q501/93
Health condition(s) or problem(s) studied	Cancer
Intervention	The intervention will consist of a one-to-one discussion with a trained mediator using a checklist of topic domains. Discussions will take place usually in participants' homes and last no more than one hour. Participants will be offered up to two further sessions with the mediator, to take place at a time of their choice. Discussions will be audio-taped and transcribed to examine the range and development of topics covered, how these change with time, and to ensure that the advisor has covered each domain as appropriate.
Intervention type	Other
Primary outcome measure	Change in scores on visual analogue scales measuring ability to discuss end-of-life planning with primary and secondary care professionals and close persons/members of the family
Secondary outcome measures	1. Completion of an advance directive 2. Psychological status 3. Satisfaction with care
Overall study start date	15/01/2007
Completion date	07/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	100
Total final enrolment	77
Key inclusion criteria	1. Have completed a primary course of treatment and still have clinically detectable, progressive, active disease 2. Are considered by the referring health professional to be well enough to complete the advance care planning discussion 3. Are over 18 years of age 4. Are able to give informed consent 5. Do not have psychotic illness 6. Speak and understand English (able to complete the questionnaires/interview)
Key exclusion criteria	1. Have not completed a primary course of treatment and still have clinically detectable, progressive, active disease 2. Are not considered by the referring health professional to be well enough to complete the advance care planning discussion 3. Are under 18 years of age 4. Are unable to give informed consent 5. Have psychotic illness 6. Do not speak and understand English (able to complete the questionnaires/interview)
Date of first enrolment	15/01/2007
Date of final enrolment	07/07/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Marie Curie Palliative Care Research Unit

London
NW3 2PF
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

Email	o.avwenagha@medsch.ucl.ac.uk
Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Dimbleby Cancer Care (United Kingdom)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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	01/03/2011		Yes	No
Plain English results		20/07/2011	29/03/2022	No	Yes

Editorial Notes

29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.