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

April 9, 2024 updated by: Tilburg University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • 's Hertogenbosch, Netherlands
        • Jeroen Bosch Hospital
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Tilburg, Netherlands
        • St. Elisabeth Hospital
      • Tilburg, Netherlands
        • TweeSteden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal cancer and their partners

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tilburg University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimated)

November 4, 2010

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL32121.008.10
  • UVT 2009-4495 (Other Grant/Funding Number: Dutch Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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