A short-term group intervention for informal carers of palliative care patients: feasibility and pilot study of a randomised controlled trial

ISRCTN	ISRCTN86241808
DOI	https://doi.org/10.1186/ISRCTN86241808
Secondary identifying numbers	RDC01028

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 07/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Irene Higginson
Scientific

Department of Palliative Care and Policy
Guy's, King's and St Thomas' School of Medicine
King's College London
Cutcombe Road
London
SE5 9RJ
United Kingdom

Phone	+44 (0)20 7848 5584
Email	irene.higginson@kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study objectives	This study is investigating the needs of carers of patients with advanced illness. It will determine whether a support group for carers is feasible, acceptable and accessible and will develop and pilot methods for its evaluation in a randomised controlled trial. Such a support group was found to be effective in one study in the US; it improved patient and carer outcomes and increased time at home. However, such a service has not been tested in this country in any rigorous evaluation. The study is based in two specialist palliative care services, both of which offer multi-professional specialist palliative home care support.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pain; palliative care
Intervention	Standard care vs short-term intervention
Intervention type	Other
Primary outcome measure	1. Zarit Burden Inventory 2. GHQ-12 3. 6-item State-Trait-Anxiety Inventory 4. Index of coping responses 5. Palliative Outcome Scale 6. Eastern Cooperative Oncology Group Performance Scale
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/1999
Completion date	01/02/2001

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Nearest carers of patients with advanced and terminal disease (mainly cancer patients but some will have other progressive diseases such as neurological or cardiovascular disease's) in the care of palliative care services at the Camden and Islington Palliative Care Centre, London and St Christopher's Hospice, London. Patients will usually be in the last months of life - average time in care of the services is 12-18 weeks. Patients and carers from a wide range of ethnic and social backgrounds. 75% are 65 years of age or older.
Key exclusion criteria	1. Younger than 18 years 2. Lack of fluent english 3. Prognosis less than 3 weeks
Date of first enrolment	01/02/1999
Date of final enrolment	01/02/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Palliative Care and Policy

London
SE5 9RJ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2002		Yes	No