Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
07/01/2010
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 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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12611318

Publication citations

  1. 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.

Additional files

Editorial Notes