No registrations found.
ID
Source
Brief title
Health condition
fatigue, small cell lung cancer (SCLC), PCI
vermoeidheid, kleincellig longcarcinoom, profylactische schedelbestraling
Sponsors and support
Intervention
Outcome measures
Primary outcome
Onset and level of fatigue after PCI measured by VAS
Secondary outcome
Onset and level of fatigue after PCI measured by additional questionnaire: MVI-20
Changes in quality of life (Qol) after PCI: EORTC c30 and EuroQol-5D
Background summary
Cancer related fatigue (CRF) is a common problem in oncological patients. 50-90% of oncological patients experience fatigue, the highest percentage is found in patients treated with chemo- and/or radiotherapy. CRF is one of the most important complaints related to cancer and its treatment. It is also a strong and independent predictor of quality of life (QoL) and patient satisfaction. After PCI, SCLC patients experience significantly more fatigue than patients who have not had PCI. Duration of fatigue after PCI is approximately 3 months, but no data exist regarding onset and peak of fatigue complaints after PCI. To plan starting time and duration of fatigue-modifying treatment, we want to evaluate in this study onset, peak and duration of fatigue after PCI (only in SCLC stage I-III) by VAS and other questionnaires
Study objective
Fatigue will be at its worst 2 to 3 weeks after prophylactic cranial irradiation (PCI)
Study design
first questionnaires to be completed in week before PCI, the first month after PCI the questionnaires have to be completed every week, the next two months the questionnaires have to be completed every two weeks
Intervention
questionnaires:
regarding fatigue: VAS and MVI-20
regarding quality of life: EORTCc30 and EuroQol 5D
PO Box 5800
L. Hendriks
Maastricht 6202 AZ
The Netherlands
+31 (0) 43 387 6543
lizza.hendriks@mumc.nl
PO Box 5800
L. Hendriks
Maastricht 6202 AZ
The Netherlands
+31 (0) 43 387 6543
lizza.hendriks@mumc.nl
Inclusion criteria
-Age >=18 years
-SCLC, pathology proven
-Completed initial treatment, with at least stable disease
-WHO PS ¡Ü 2
-Ability to understand written questionnaires
-Written informed consent
Exclusion criteria
- clinically relevant anemia (defined as Hb < 6 mmol/l)
- chronic renal failure (defined as MDRD-eGFR < 45 ml/min/1.73m)
- liver biochemistry abnormalities (defined as more than two times upper limit of normal)
- major psychiatric illness requiring intervention in secondary care
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 | NL4067 |
| NTR-old | NTR4218 |
| Other | : METC 13-4-074 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |