Understanding psychological distress in cervical cancer patients and their partners
Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
Comprehensive Cancer Centre The Netherlands · NCT04475354
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 |
|---|---|
| Enrollment | 832 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Comprehensive Cancer Centre The Netherlands (other) |
| Locations | 6 sites (Breda and 5 other locations) |
| Trial ID | NCT04475354 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed cervical cancer patients at stages I, II, or III, aged over 18, and their partners.
Not a fit: Patients with cognitive impairments or those unable to read or write in Dutch may not benefit from this study.
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 performed: While there have been studies on psychological distress in cancer patients, this specific approach focusing on cervical cancer and its partners is relatively novel.
Eligibility criteria
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 this trial is running
Breda and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship, Quality of Life