Condition category
Cancer
Date applied
08/01/2007
Date assigned
16/02/2007
Last edited
02/08/2012
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

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

http://www.ucl.ac.uk/

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

  1. 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.

Additional files

Editorial Notes