|- candidate number||13172|
|- NTR Number||NTR3540|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jul-2012|
|- Secondary IDs||2009/346 METc|
|- Public Title||Value of structural psychosocial screening in improving quality of life and satisfaction with care received in patients with lung cancer.|
|- Scientific Title||Value of structural psychosocial screening in improving quality of life and satisfaction with care received in patients with lung cancer.|
|- ACRONYM||Care Study|
|- hypothesis||Care and treatment guided by structural psychosocial screening leads to a better quality of life and greater patient satisfaction than usual care in patients with lung cancer.|
The second goal is to relate the change in quality of life with the total costs incurred both inside and outside the hospital.
|- Healt Condition(s) or Problem(s) studied||Lung cancer, Distress thermometer, Case-management, Quality of life, Psychosocial signaling|
|- Inclusion criteria||1. Starting a treatment with chemotherapy for either recently confirmed diagnosis of lung cancer, documented recurrence of lung cancer, thymoma or mesothelioma;|
2. Disease stage Ib - IV;
3. ECOG Performance score 0-2;
4. Age > 18 years.
|- Exclusion criteria||Actual psychiatric disorder.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-jan-2014|
|- Target number of participants||250|
|- Interventions||Patients in the standard care group will receive the usual care and attention of the health care professionals as dictated by the institute. |
Patients in the experimental group will receive extra psychosocial care delivered by an oncology nurse on top of the standard care. This extra care consists of, care guided by structural psychosocial screening with a screening instrument (the Dutch version of the distress thermometer and problem [DTP] list). These patients will complete the DTP list within 3 weeks, and at 7, 13 and 25 weeks after inclusion. The DTP lists will be sent to the patient 1 week prior to the outpatient clinic visit. The oncology nurse will act as case manager for patients in the experimental group. At each of the visits, the oncology nurse will discuss the response pattern from the DTP list with the patient. When needed, she will refer the patient to a psychosocial health care provider. In addition, when indicated, responses will also be discussed in the multidisciplinary psychosocial team.
|- Primary outcome||Quality of life (QOL) as measured by the EORTC-QLQ-30 questionnaire and its lung module QLQ-LC13, the Hospital anxiety and depression scale and the EuroQol 5 EQ-5D.|
|- Secondary outcome||1. Patient satisfaction with care;|
2. Total costs both inside and outside the hospital/cost effectiveness;
3. Progression free and overall survival.
Measured bij Patient satisfaction questionnaire, Tic-P and generic cost-effectiveness questionnaire on top of questionaires mentioned above.
|- Timepoints||Participants will be asked to complete questionnaires after inclusion, when they have started with chemotherapie. Again at 7 (T2), 13 (T3) and 25 weeks (T4) later.|
All questionnaires will be sent to (surviving) participants again at one and two years after completion of the study to examine long-term effects.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. H.A.M. Kerstjens|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T.J.N. Hiltermann|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Doelmatigheidsfonds University Medical Center Groningen |
|- Brief summary||The aim is to examine, whether care and treatment guided by structural psychosocial screening, leads to a better quality of life and increased patient satisfaction than usual care in patients with lung cancer. Psychosocial screening consists of regular and structural screening of problems using the Dutch Distress Thermometer and Problem (DTP) list, communication with the patient regarding the response pattern, and referral to a psychosocial or paramedic care giver when indicated or desired by the patient. Eligible are all patients visiting the UMCG department of lung oncology with a recently confirmed diagnosis of lung cancer or recently documented recurrence. The study has a randomized parallel design. Patients will be randomly assigned to either standard care or to the experimental group. Patients in the experimental group will receive care guided by repeated structural psychosocial screening with the DTP list on top of usual care.
Primary outcome parameter is: Quality of life; secondary outcomes are: patient satisfaction with care, total costs both inside and outside the hospital, cost effectiveness, progression free and overall survival.|
|- Main changes (audit trail)|
|- RECORD||27-jul-2012 - 5-aug-2012|