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

NCT ID: NCT01234246

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Colorectal Cancer Patients and Their Partners

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with colorectal cancer

Patients with colorectal cancer are included

No interventions assigned to this group

Partners

Partners of patients with colorectal cancer are included

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Cancer Society

OTHER

Sponsor Role collaborator

Tilburg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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B.L. den Oudsten, PhD

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

J.A. Roukema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

J. de Vries, PhD

Role: PRINCIPAL_INVESTIGATOR

Tilburg University

Locations

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Jeroen Bosch Hospital

's-Hertogenbosch, , Netherlands

Site Status

Catharina Hospital

Eindhoven, , Netherlands

Site Status

St. Elisabeth Hospital

Tilburg, , Netherlands

Site Status

TweeSteden Hospital

Tilburg, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://www.uvt.nl/corps

Website of the Center of Research on Psychology in Somatic Diseases

http://www.kwfkankerbestrijding.nl

Website of the Dutch Cancer Society

Other Identifiers

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UVT 2009-4495

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL32121.008.10

Identifier Type: -

Identifier Source: org_study_id

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