(TRIAL TERMINATED - problems with recruitment) Effects of guiding informal caregivers of terminal cancer patients who stay at home, by district nurses who are specialised in palliative care/oncology
| ISRCTN | ISRCTN37522734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37522734 |
| Secondary identifying numbers | 25073; NTR157 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 10/08/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Marta van Dijk
Scientific
Scientific
Integraal Kankercentrum Limburg
P.O.Box 2208
Maastricht
6201 HA
Netherlands
| Phone | +31 (0)43 325 4059 |
|---|---|
| m.vandijk@ikl.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | Gids-project (Guidance of informal carers by district nurses) |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/04/2005 |
| Completion date | 28/02/2006 |
| Reason abandoned (if study stopped) | Problems with recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/04/2005 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Integraal Kankercentrum Limburg
Maastricht
6201 HA
Netherlands
6201 HA
Netherlands
Sponsor information
Comprehensive Cancer Centre Limburg (The Netherlands)
Charity
Charity
P.O. Box 2208
Maastricht
6201 HA
Netherlands
Funders
Funder type
Government
Province of Limburg (Netherlands)
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 |
