|- candidate number||15610|
|- NTR Number||NTR4226|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-okt-2013|
|- Secondary IDs||NL41659.078.12 |
|- Public Title||Social and psychological support for adolescents and young adults with Neurofibromatosis type 1|
|- Scientific Title||Social and psychological support for adolescents and young adults with NF1|
|- hypothesis||The disease related intervention improves the psychosocial quality of life and self-efficacy of young adults with NF1.|
|- Healt Condition(s) or Problem(s) studied||Neurofibromatosis I, Social support, Participation|
|- Inclusion criteria||Patient diagnosed with NF1 by a doctor via the official NIH criteria;|
Age: 16-30 years;
A signed informed consent by the patient and if the patient is a minor, then a signed informed consent by the parents is needed as well.
|- Exclusion criteria||Young adolescents without official diagnosis of Neurofibromatosis type 1;|
Participants who do'nt have enough knowledge about the Dutch language to fill in the questionnaires.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-sep-2041|
|- Target number of participants||100|
|- Interventions||5 psychological and social support groups and a maximum of 4 individual sessions|
|- Primary outcome||Mental quality of life (SF-36, mental scale)|
|- Secondary outcome||Physical quality of life (SF-36, physical scale);
Self efficacy in coping with a chronic condition(Dutch versions of the On Your Own Feet - Self Efficacy Scale and General Self Efficacy Scale);
Level of fatigue (Dutch version of the Checklist Individual Strength);
Participation in daily life (Dutch questionnaire: Impact op Participatie en Autonomie, several subscales will be used (roughly translated): pastime and recreation, social contacts and relationships, paid work or volunteer work, education and courses;
Specific questionnaire to measure the burden of appearance in NF1 (pilot dutch questionnaire "The burden of Visibility of NF1);
Service satisfaction: some questions abbreviated from the Verona Service Satisfaction Scale|
|- Timepoints||The questionnaires will be filled in at the intake (T0) and six months later, at T=6.|
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C. Bouman|
|- CONTACT for SCIENTIFIC QUERIES|| C. Bouman|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||From 2013 to 2014 we conduct a study in the Sophia Children's Hospital in Rotterdam for young people with NF1 (age 16-30 years).
The aim of the study is twofold: chart the need for care and advice, quality of life, self efficacy, psychopathology and participation in society and measure the effectivity of a short, disease related intervention designed to improve psychosocial quality of life.
SPOT-NF1 is a randomized controlled study: participants are randomly assigned to the treatment group or the control group, controlling for current psychological therapy.
Treatment consists of five two-hour group sessions, and if needed individual sessions with social worker or psychologist and digital support by a Facebook site.
|- Main changes (audit trail)|
|- RECORD||25-okt-2013 - 23-dec-2013|