NCT01234246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

3.5 years

First QC Date

November 3, 2010

Last Update Submit

April 9, 2024

Conditions

Keywords

Colorectal cancerSexual functionSexual dysfunctionQuality of (sexual) lifePartnersBody imageAnxiety (state and trait)Depressive symptomsPersonality

Study Arms (2)

Patients with colorectal cancer

Patients with colorectal cancer are included

Partners

Partners of patients with colorectal cancer are included

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal cancer and their partners

You may qualify if:

  • 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.

You may not qualify if:

  • Disease recurrence at baseline or metastases.
  • Poor expression of the Dutch language.
  • Dementia.
  • History of psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

St. Elisabeth Hospital

Tilburg, Netherlands

Location

TweeSteden Hospital

Tilburg, Netherlands

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsSexual Dysfunction, PhysiologicalCoitusAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital DiseasesUrogenital DiseasesSexual BehaviorBehaviorMental DisordersBehavioral Symptoms

Study Officials

  • B.L. den Oudsten, PhD

    Tilburg University

    PRINCIPAL INVESTIGATOR
  • J.A. Roukema, MD, PhD

    Tilburg University

    PRINCIPAL INVESTIGATOR
  • J. de Vries, PhD

    Tilburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations