Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23161
Enrollment
152
Registered
2007-12-19
Start date
2007-10-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Advanced cancer

Interventions

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 recei

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
General fatigue at baseline and 1, 2 and 3 months after baseline. Measured with the MFI.

Secondary

MeasureTime frame
1. Quality of life (EORTC QLQ C30); 2. Multidimensional fatigue (MFI); 3. Daily interference of fatigue (BFI); 4. Anxiety and depression (HADS); 5. Survival.

Contacts

Public ContactP.J. Raaf, de

Erasmus MC Interne Oncologie - kamer G0-03 Antwoordnummer 70780

p.deraaf@erasmusmc.nl+31 (0)107041439

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)