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Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.

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ClinicalTrials.gov Identifier: NCT01234246
Recruitment Status : Unknown
Verified August 2010 by University of Tilburg.
Recruitment status was:  Recruiting
First Posted : November 4, 2010
Last Update Posted : November 4, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease
Colorectal Cancer Patients and Their Partners

Study Design

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
Study Start Date : March 2010
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients with colorectal cancer
Patients with colorectal cancer are included
Partners
Partners of patients with colorectal cancer are included


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal cancer and their partners
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234246


Contacts
Contact: M.J. Traa, MSc 0031 13 466 4129 m.j.traa@uvt.nl

Locations
Netherlands
Jeroen Bosch Hospital Recruiting
's Hertogenbosch, Netherlands
Catharina Hospital Recruiting
Eindhoven, Netherlands
St. Elisabeth Hospital Recruiting
Tilburg, Netherlands
TweeSteden Hospital Recruiting
Tilburg, Netherlands
Sponsors and Collaborators
University of Tilburg
Dutch Cancer Society
Investigators
Principal Investigator: B.L. den Oudsten, PhD Tilburg University
Principal Investigator: J.A. Roukema, MD, PhD Tilburg University
Principal Investigator: J. de Vries, PhD Tilburg University
More Information

Additional Information:
Responsible Party: J. de Vries, Tilburg Unviersity - Center of Research on Psychology in Somatic Diseases
ClinicalTrials.gov Identifier: NCT01234246     History of Changes
Other Study ID Numbers: NL32121.008.10
UVT 2009-4495 ( Other Grant/Funding Number: Dutch Cancer Society )
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: August 2010

Keywords provided by University of Tilburg:
Colorectal cancer
Sexual function
Sexual dysfunction
Quality of (sexual) life
Partners
Body image
Anxiety (state and trait)
Depressive symptoms
Personality

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases