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A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU).


- candidate number2965
- NTR NumberNTR1170
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2007
- Secondary IDsEMC 07-005 
- Public TitleA randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU).
- Scientific TitleA randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU).
- ACRONYMN/A
- hypothesisPatients 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).
- Healt Condition(s) or Problem(s) studiedCancer, Fatigue
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2007
- planned closingdate15-okt-2010
- Target number of participants152
- InterventionsPatients 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.
- Primary outcomeGeneral fatigue at baseline and 1, 2 and 3 months after baseline. Measured with the MFI.
- Secondary outcome1. Quality of life (EORTC QLQ C30);
2. Multidimensional fatigue (MFI);
3. Daily interference of fatigue (BFI);
4. Anxiety and depression (HADS);
5. Survival.
- TimepointsT0 = at baseline (before randomization);
T1 = 1 month after baseline;
T2 = 2 months after baseline;
T3 = 3 months after baseline.
- Trial web sitehttp://www.erasmusmc.nl/kenniscentrum-palliatieve-zorg/3068529/3155358/RCT_vermoeidheid?lang=en
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. P.J. Raaf, de
- CONTACT for SCIENTIFIC QUERIESMD. C.C.D. Rijt, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryFatigue 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.
- Main changes (audit trail)
- RECORD19-dec-2007 - 25-jul-2011


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