|- candidate number||8549|
|- NTR Number||NTR2568|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-okt-2010|
|- Secondary IDs||NL32121.008.10 CCMO|
|- Public Title||Sexual functioning and the quality of sexual life in patients with colorectal cancer and their partners.|
|- Scientific Title||Sexual functioning and the quality of sexual life in patients with colorectal cancer and their partners.|
|- hypothesis||Sexual dysfunction is present, to some extent, in most patients after the treatment for colorectal cancer.
There is a relationship between both treatment-related (e.g., type of surgery) and psychosocial factors (e.g., depressive symptoms) and sexual dysfunction, the quality of sexual life and the partnerrelationship.
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Quality of life, Sexual dysfunction|
|- Inclusion criteria||1. Patients who are diagnosed with colorectal cancer in one of the participating centra, and their partners are asked to participate in this study prior to treatment;|
2. Patients have to be between 18 and 75 years old.
|- Exclusion criteria||1. Disease recurrence at baseline or metastases;|
2. Poor expression in the Dutch language;
4. History of psychiatric illness.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||15-mrt-2010|
|- planned closingdate||15-mrt-2014|
|- Target number of participants||600|
|- Interventions||Patients will receive care as usual. Participants and their partners will complete several questionnaires (e.g., sexual functioning, depressive symptoms, quality of life, personality) before treatment (T0), 6 weeks (T1), 3 months (T2), 6 months (T3), and 12 months (T4) after treatment.|
|- Primary outcome||The objectives of this study will be to examine:|
1. The incidence of sexual problems and the extent patients with colorectal cancer are bothered by these problems across time;
2. The effect of different treatment options on sexual functioning;
3. The association between sexual problems and quality of life;
4. The determinants of sexual problems and quality of sexual life adopting the biopsychosocial approach of patients with colorectal cancer who have been treated with surgery, radiation and/or chemotherapy, and more specifically to the role of personality and partner factors and sexual functioning/quality of sexual life.
|- Secondary outcome||N/A|
|- Timepoints||Questionnaires are completed before treatment (T0), 6 weeks (T1), 3 months (T2), 6 months (T3), and 12 months (T4) after treatment. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. M.J. Traa|
|- CONTACT for SCIENTIFIC QUERIES||PhD. J. Vries, de|
|- Sponsor/Initiator ||University of Tilburg |
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||12-okt-2010 - 30-okt-2010|