Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marta van Dijk

ORCID ID

Contact details

Integraal Kankercentrum Limburg
P.O.Box 2208
Maastricht
6201 HA
Netherlands
+31 (0)43 325 4059
m.vandijk@ikl.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

25073; NTR157

Study information

Scientific title

Acronym

Gids-project (Guidance of informal carers by district nurses)

Study hypothesis

Informal caregivers in the experimental group are expected to be more satisfied with the care provided to them and the patient they take care of, to experience a less heavy burden, and to have a better health compared to the informal caregivers who are assigned to the control group and will receive standard care.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Terminal cancer

Intervention

Four one-hour home visits by district nurses who are specialised in palliative care/oncology over a period of six weeks, in order to support informal caregivers in handling problems they are faced with when taking care of a terminally ill cancer patient.

Next to the visits of the district nurses, informal caregivers in the experimental group receive written information about self-care for informal caregivers and contact with other informal caregivers. They also receive information about national and local organizations involved in the care for informal caregivers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Satisfaction of the informal caregivers with the care provided to them and the patient they take care of. Measured at baseline and eight weeks later, with the Maastricht measuring-Instrument Satisfaction Terminal Care (in Dutch: Maastrichts meetInstrument Tevredenheid Terminale Zorg - MITTZ).
2. Burden perceived by the informal caregivers, measured at baseline and eight weeks later, with the Caregiver Reaction Assessment-Dutch (CRA-D)
3. Health of the informal caregivers, measured at baseline and eight weeks later, with the MOS 36-item Short Form Health Survey (SF-36)

Secondary outcome measures

The use of health care facilities by both the informal caregivers and the patients, measured over a period of eight weeks, by means of a care diary.

Overall trial start date

15/04/2005

Overall trial end date

28/02/2006

Reason abandoned

Problems with recruitment

Eligibility

Participant inclusion criteria

Informal caregivers can enter the study if they take care of a patient who has been diagnosed with cancer and has a life expectancy of less than four months. Next to these criteria, the patient has to spend his last months largely at home and has to be at least 18 years old. Informal caregivers can also take part in the study if they are not involved in the care for the patient at the moment, but are expected to be in the near future.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

Informal caregivers who take care of a cancer patient with a life expectancy of less than two months, because this interferes with the post-measurement eight weeks after inclusion

Recruitment start date

15/04/2005

Recruitment end date

28/02/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Integraal Kankercentrum Limburg
Maastricht
6201 HA
Netherlands

Sponsor information

Organisation

Comprehensive Cancer Centre Limburg (The Netherlands)

Sponsor details

P.O. Box 2208
Maastricht
6201 HA
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Government

Funder name

Province of Limburg (Netherlands)

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

Publication citations

Additional files

Editorial Notes