Colorectal Cancer Patients and Their PartnersNCT01234246
Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
An observational study of Colorectal Cancer Patients and Their Partners, run by Tilburg University at 4 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Patients and Their Partners
- How many people
- 1,371 participants
- Where
- 4 sitesNetherlands
- Study dates
- Sep 2010to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancer and their partners
Who may be able to join
- 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.
Who cannot join
- Disease recurrence at baseline or metastases.
- Poor expression of the Dutch language.
- Dementia.
- History of psychiatric illness.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Catharina Hospital
Eindhoven
St. Elisabeth Hospital
Tilburg
TweeSteden Hospital
Tilburg
About this study
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.
- Keywords
- Colorectal cancer, Sexual function, Sexual dysfunction, Quality of (sexual) life, Partners, Body image, Anxiety (state and trait), Depressive symptoms, Personality
- Medical subject headings
- Colorectal Neoplasms, Sexual Dysfunction, Physiological, Coitus, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer | Patients with colorectal cancer are included | |
| Partners | Partners of patients with colorectal cancer are included |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Patients and Their PartnersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilburg University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- B.L. den Oudsten, PhD, Principal investigator, Tilburg UniversityJ.A. Roukema, MD, PhD, Principal investigator, Tilburg UniversityJ. de Vries, PhD, Principal investigator, Tilburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234246
- Sponsor's protocol ID
- NL32121.008.10
- Other IDs
- UVT 2009-4495
- Status last verified
- Apr 2024
- First submitted
- 3 Nov 2010
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.
- ClinicalTrials.gov ID
- NCT01234246
- Acronym / sponsor ID
- NL32121.008.10
- Keywords
- Colorectal cancer, Sexual function, Sexual dysfunction, Quality of (sexual) life, Partners, Body image, Anxiety (state and trait), Depressive symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,371 participants (actual)
- Lead sponsor
- Tilburg UniversityUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Sep 2010 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer | – | –Patients with colorectal cancer are included |
| Partners | – | –Partners of patients with colorectal cancer are included |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer and their partners
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Disease recurrence at baseline or metastases.
- Poor expression of the Dutch language.
- Dementia.
- History of psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Website of the Center of Research on Psychology in Somatic DiseasesLink provided by the sponsor.
- Website of the Dutch Cancer SocietyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B.L. den Oudsten, PhD principal investigator
Tilburg University
J.A. Roukema, MD, PhD principal investigator
Tilburg University
J. de Vries, PhD principal investigator
Tilburg University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Patients and Their Partners, run by Tilburg University at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.