Understanding psychological distress in cervical cancer patients and their partners
Official title: Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
Run by Comprehensive Cancer Centre The Netherlands · NCT04475354 · Data updated 2026-11-12
This study looks at the emotional struggles faced by cervical cancer patients and their partners over time to better understand what affects their mental health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 832 (estimated) |
| Sponsor | Comprehensive Cancer Centre The Netherlands Academic / other |
| Locations | 6 sites (Breda and 5 other locations) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | January 2024 |
| Study ends | January 2030 |
| Registry record updated | December 6, 2023 |
| Trial ID | NCT04475354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newly diagnosed cervical cancer patients at stages I, II, or III, aged over 18, and their partners.
✕Probably not a fit
Patients with cognitive impairments or those unable to read or write in Dutch may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the psychological distress experienced by cervical cancer patients and their partners over a period of up to 10 years. Newly diagnosed patients will be followed and asked to complete questionnaires at multiple time points, while a subsample will also provide biological and lifestyle data. The study will analyze various factors, including individual characteristics and environmental influences, to understand the mechanisms behind psychological distress in this population.
Why it matters
Potential benefit: If successful, this study could lead to improved psychological support and interventions for cervical cancer patients and their partners.
How similar studies have gone: While there have been studies on psychological distress in cancer patients, this specific approach focusing on cervical cancer and its partners is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Patients Inclusion Criteria: * Newly diagnosed with cervical cancer stage I, II or III * \>18 years or older Exclusion Criteria: * Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance. * Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire. Partners Inclusion Criteria: * Partner of patient participating in the study * \>18 years Exclusion Criteria: * Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance. * Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
Where it's running
-
Amphia
Breda, Netherlands Recruiting -
Catharina Hospital
Eindhoven, Netherlands Recruiting -
University Medical Center Groningen
Groningen, Netherlands Recruiting -
Mumc
Maastricht, Netherlands Recruiting -
RadboudUMC
Nijmegen, Netherlands Recruiting -
UMC Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Nicole Ezendam — Netherlands Comprehensive Cancer Organisation
- Study coordinator: Nicole Ezendam, PhD
- Email: N.Ezendam@iknl.nl
- Phone: +31 88 234 6096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.