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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01234246
Other study ID # NL32121.008.10
Secondary ID UVT 2009-4495
Status Completed
Phase
First received
Last updated
Start date September 2010
Est. completion date March 2014

Study information

Verified date April 2024
Source Tilburg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this project the main focus is on assessing sexual functioning and the quality of sexual life after the treatment of colorectal cancer in patients and their partners. Patients and their partners complete questionnaires concerning sexual functioning, quality of life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months, and 12 months after diagnosis. The results of this prospective study will give insight in 1) the incidence of sexual problems and the extent patients with colorectal cancer and their partners are bothered by these problems across time, 2) the effect of different treatment modalities on sexual functioning, 3) the relation between sexual problems and quality of life, 4) the determinants of sexual problems and the 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 patient factors and sexual functioning/the quality of sexual life.


Recruitment information / eligibility

Status Completed
Enrollment 1371
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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. - Patients have to be between 18 and 75 years old. Exclusion Criteria: - Disease recurrence at baseline or metastases. - Poor expression of the Dutch language. - Dementia. - History of psychiatric illness.

Study Design


Locations

Country Name City State
Netherlands Jeroen Bosch Hospital 's Hertogenbosch
Netherlands Catharina Hospital Eindhoven
Netherlands St. Elisabeth Hospital Tilburg
Netherlands TweeSteden Hospital Tilburg

Sponsors (2)

Lead Sponsor Collaborator
Tilburg University Dutch Cancer Society

Country where clinical trial is conducted

Netherlands,