| - candidate number | 7878 |
| - NTR Number | NTR2260 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 25-mrt-2010 |
| - Secondary IDs | 10-N-02 METC AMC |
| - Public Title | Course of psychosocial problems of lungcancerpatients before, during and after treatment (chemotherapy). |
| - Scientific Title | Course of distress, anxiety and depression of lungcancerpatients during chemotherapy. |
| - ACRONYM | |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Lung cancer, Chemotherapy |
| - Inclusion criteria | Men and women, older than 18 years, with lungcancer treated with chemotherapy. |
| - Exclusion criteria | 1. Mesothelioma; 2. Patients with radiotherapy or chirurgy. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | Single arm |
| - Studytype | observational |
| - planned startdate | 1-apr-2010 |
| - planned closingdate | 1-apr-2012 |
| - Target number of participants | 112 |
| - Interventions | N/A |
| - Primary outcome | Distress, anxiety and depression measured with SIPP and Distress thermometer, HADS and MAC-scale. |
| - Secondary outcome | 1. Copingstyle; 2. Physical distress. |
| - Timepoints | Before, during and three months after chemotherapy
using: 1. SIPP and Distress thermometer (distress); 2. HADS (anxiety and depression); 3. MAC-scale (copingstyle). |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs. C. Helden, van |
| - CONTACT for SCIENTIFIC QUERIES | Dr. A. Hout, van den |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Medical Psychology |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam |
| - Publications | N/A |
| - Brief summary | This study investigates the course of distress, anxiety and depression during chemotherapy (before, during en 3 months after) by lungcancerpatients, the effects of fysical complaints and copingstyle on distress, anxiety and depression and the effect of copingstyle on distress. Patients are recruited in The Netherlands. |
| - Main changes (audit trail) | |
| - RECORD | 25-mrt-2010 - 5-apr-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl