No registrations found.
ID
Source
Brief title
Health condition
1. Advanced cancer;
2. fatigue;
3. cancer-related fatigue;
4. CRF;
5. palliative care.
(NLD: kanker, vermoeidheid, kankergerelateerde vermoeidheid, palliatieve zorg).
Sponsors and support
Zon MW
Intervention
Outcome measures
Primary outcome
General fatigue at baseline and 1, 2 and 3 months after baseline. Measured with the MFI.
Secondary outcome
1. Quality of life (EORTC QLQ C30);
2. Multidimensional fatigue (MFI);
3. Daily interference of fatigue (BFI);
4. Anxiety and depression (HADS);
5. Survival.
Background summary
Fatigue is a common and complex symptom in advanced cancer patients and is known to considerably influence daily activity and quality of life. The etiology of fatigue is not yet completely understood, but physical symptoms seem to be part of it. This study focuses on the relationship between physical symptoms and fatigue. Palliatively treated out-patients reporting fatigue are invited to participate in the study for three months. Patients are randomized to the control group or the intervention group. Patients in the control group receive care as usual. Patients in the intervention group are seen by a nurse specialist who monitors their physical symptoms. Depending on the severity of the physical symptom(s), the nurse specialist will give information on how to deal with the symptom(s) or contact the patient's physician for treatment. Participants are requested to complete questionnaires concerning multidimensional fatigue, quality of life, daily interference of fatigue, anxiety and depression at baseline and 1, 2 and 3 months after baseline. Patients in the intervention group are expected to show greater improvement on general fatigue compared to patients receiving care as usual.
Study objective
Patients receiving systematic monitoring and multidisciplinary protocolized patient-tailored treatment of physical symptoms (PPT) are expected to show greater improvement on general fatigue compared to patients receiving care as usual (CAU).
Study design
T0 = at baseline (before randomization);
T1 = 1 month after baseline;
T2 = 2 months after baseline;
T3 = 3 months after baseline.
Intervention
Patients in both arms of the study participate for 3 months. For patients in the intervention group, physical symptoms will be monitored systematically and treated. Patients in the control group receive care as usual.
P.J. Raaf, de
Erasmus MC Interne Oncologie - kamer G0-03 Antwoordnummer 70780
Rotterdam 3070 WB
The Netherlands
+31 (0)107041439
p.deraaf@erasmusmc.nl
P.J. Raaf, de
Erasmus MC Interne Oncologie - kamer G0-03 Antwoordnummer 70780
Rotterdam 3070 WB
The Netherlands
+31 (0)107041439
p.deraaf@erasmusmc.nl
Inclusion criteria
1. Histologically or cytologically proven solid malignancy;
2. Palliatively aimed treatment;
3. Treatment in the outpatient clinic;
4. Fatigue scored as 4 or higher on a scale of 0 to 10;
5. 18 years or older;
6. WHO performance status of 0,1 or 2;
7. Life expectancy at least months;
8. Able to write and speak Dutch;
9. Signed informed consent.
Exclusion criteria
1. Concomitant (or within 4 weeks before randomization) administration of any
experimental drug;
2. Untreated depression or anxiety disorders;
3. Severe comorbidity, e.g. heart failure or symptomatic chronic obstructive lung disease;
4. Stay in nursing home;
5. Cognitive limitations.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL665 |
| NTR-old | NTR1170 |
| Other | : EMC 07-005 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |