|- candidate number||1267|
|- NTR Number||NTR157|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||29-aug-2005|
|- Secondary IDs||25073 |
|- Public Title||Effects of guiding informal caregivers of terminal cancer patients who stay at home, by district nurses who are specialized in palliative care / oncology. |
|- Scientific Title||Effects of guiding informal caregivers of terminal cancer patients who stay at home, by district nurses who are specialized in palliative care / oncology. |
|- ACRONYM||Gids-project (Guidance of informal carers by district nurses)|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Cancer, Terminal cancer|
|- 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.
|- 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. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-apr-2005|
|- planned closingdate||28-feb-2006|
|- Target number of participants||90|
|- Interventions||Four one-hour home visits by district nurses who are specialized 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.
|- Primary outcome||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||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.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Msc. M. Dijk, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I.M. Proot|
|- Sponsor/Initiator ||Comprehensive Cancer Centre (IKA) Limburg, University Maastricht (UM), Institute for Bioethics |
(Source(s) of Monetary or Material Support)
|Province of Limburg|
|- Brief summary||Within the scope of the present study, the effects of a guiding programme for informal caregivers of terminal cancer patients who stay at home will be examined. The intervention is carried out by district nurses who are specialized in palliatiev care / oncology. |
The purpose of the study is twofold:
- first, to develop a training programme for district nurses, concerning the guidance of informal caregivers of terminally ill cancer patients who stay at home, and
- second, to measure the effects of an experimental nursing intervention that is put into practice by the nurses who followed the training programme.
The district nurses visit the informal caregivers in the experimental group four times during one hour, over a period of six weeks. The nurses evaluate the situation of the informal caregiver and the patient. On the basis of this information, they assess what kind of information and support the informal caregiver needs. By doing so, guidance can be provided with regard to the needs of the individual caregiver and with regard to the specific caregiving tasks of thr informal caregiver in view of the patient's situation.
Outcome measures are:
1. Satisfaction of the informal caregivers with the care provided to them and the patient they take care of;
2. Burden perceived by the informal caregivers;
3. Health of the informal caregivers;
4. The use of health care facilities by both the informal caregiver and the patient.
|- Main changes (audit trail)|
|- RECORD||22-aug-2005 - 6-nov-2008|