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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Tilburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by:
University of Tilburg
ClinicalTrials.gov Identifier:
NCT01234246
First received: November 3, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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
Colorectal Cancer Patients and Their Partners

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.

Resource links provided by NLM:


Further study details as provided by University of Tilburg:

Estimated Enrollment: 1200
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Groups/Cohorts
Patients with colorectal cancer
Patients with colorectal cancer are included
Partners
Partners of patients with colorectal cancer are included

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Sexual Dysfunctions, Psychological
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014