Contact information
Type
Scientific
Primary contact
Dr Louise Jones
ORCID ID
Contact details
Marie Curie Palliative Care Research Unit
Royal Free and University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
l.jones@medsch.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Royal Free Hospital and Medical School Local Research Ethics Committee. Approved on 17.08.06, ref 06/Q501/93
Study design
Randomised controlled patient preference trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/01/2007
Overall trial end date
07/07/2008
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant 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)
Recruitment start date
15/01/2007
Recruitment end date
07/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Marie Curie Palliative Care Research Unit
London
NW3 2PF
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
o.avwenagha@medsch.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Dimbleby Cancer Care (United Kingdom)
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21352613
Publication citations
-
Results
Jones L, Harrington J, Barlow CA, Tookman A, Drake R, Barnes K, King M, Advance care planning in advanced cancer: can it be achieved? An exploratory randomized patient preference trial of a care planning discussion., Palliat Support Care, 2011, 9, 1, 3-13, doi: 10.1017/S1478951510000490.