Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 3, 2010 | ||||||||||||
| Last Updated Date | November 3, 2010 | ||||||||||||
| Start Date ICMJE | March 2010 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners. | ||||||||||||
| Official Title ICMJE | Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners. | ||||||||||||
| Brief 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. |
||||||||||||
| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| Study Population | Patients with colorectal cancer and their partners |
||||||||||||
| Condition ICMJE | Colorectal Cancer Patients and Their Partners | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) |
|
||||||||||||
| Publications * | Not Provided | ||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 1200 | ||||||||||||
| Estimated Completion Date | March 2014 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 18 Years to 75 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
|
||||||||||||
| Location Countries ICMJE | Netherlands | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01234246 | ||||||||||||
| Other Study ID Numbers ICMJE | NL32121.008.10, UVT 2009-4495 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | J. de Vries, Tilburg Unviersity - Center of Research on Psychology in Somatic Diseases | ||||||||||||
| Study Sponsor ICMJE | University of Tilburg | ||||||||||||
| Collaborators ICMJE | Dutch Cancer Society | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | University of Tilburg | ||||||||||||
| Verification Date | August 2010 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||