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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2568 |
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Date of registration:
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12/10/2010 |
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Primary sponsor: |
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Public title:
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Sexual functioning and the quality of sexual life in patients with colorectal cancer and their partners.
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Scientific title:
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Sexual functioning and the quality of sexual life in patients with colorectal cancer and their partners. -
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Date of first enrolment:
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15/3/2010 |
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Target sample size:
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600 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2568 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: [default]; Control: [default]; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.
Vries, de |
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Address:
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Postbus 90153, Warandelaan 2
5000 LE
Tilburg
The Netherlands |
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Telephone:
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+31 (0)13 4662705 |
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Email:
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j.devries@uvt.nl |
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Affiliation:
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Name:
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M.J.
Traa |
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Address:
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Postbus 90153, Warandelaan 2
5000 LE
Tilburg
The Netherlands |
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Telephone:
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+31 (0)13 4664129 |
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Email:
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m.j.traa@uvt.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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;
3. Dementia;
4. History of psychiatric illness.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Colorectal cancer, Quality of life, Sexual dysfunction
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary ID(s)
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NL32121.008.10
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Source(s) of Monetary Support
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Dutch Cancer Society
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