Contact information
Type
Scientific
Primary contact
Dr Irene Higginson
ORCID ID
Contact details
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
+44 (0)20 7848 5584
irene.higginson@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDC01028
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Pain; palliative care
Intervention
Standard care vs short-term intervention
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/02/1999
Overall trial end date
01/02/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Younger than 18 years
2. Lack of fluent english
3. Prognosis less than 3 weeks
Recruitment start date
01/02/1999
Recruitment end date
01/02/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Palliative Care and Policy
London
SE5 9RJ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (UK)
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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12611318
Publication citations
-
Results
Harding R, Leam C, Pearce A, Taylor E, Higginson IJ, A multi-professional short-term group intervention for informal caregivers of patients using a home palliative care service., J Palliat Care, 2002, 18, 4, 275-281.