NCT04475354Recruiting
Distress In CErvical Cancer Patients and Partners
Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
Source: ClinicalTrials.gov · Last updated 6 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Rationale: A growing number of cervical cancer patients live years beyond their cancer diagnosis and ultimately survive their disease. Cervical cancer patients report higher levels of psychological distress compared to other (gynecological) cancer types, resulting in physical and psychosocial limitations. The mechanisms explaining why some patients do, and others do not experience persistent psychological distress after cervical cancer remain unclear. Objective: Gain insight into the mechanisms explaining psychological distress (i.e. anxiety, depression, cancer worry, perceived stress) in a prospective population-based sample of cervical cancer patients. Factors to be studied include characteristics of the individual (demographical and clinical, including comorbidities), characteristics of the environment ((sexual) relationships), biological function (cortisol, melatonin and sex hormone production assessed in scalp hair, inflammation and telomere length assessed in blood, overall quality of life (EORTC QLQ-C30), symptoms (EORTC QLQ-CX24), functional status (physical activity and sleep measured using the Actigraph activity tracker, and food intake measured using the online 'Eetmeter'), and general health perceptions (B-IPQ). The second aim is to assess the impact of cervical cancer on partners' distress (cancer worry, illness perceptions, relationship quality, dyadic coping).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 832 (estimated)
- First submitted
- 16 Jan 2020
- Start date
- 1 Nov 2020
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Comprehensive Cancer Centre The Netherlands
- Diseases
- Cervical cancer
- NCT number
- NCT04475354
What you commit to
- Study type: Observational
- Planned participants: 832
- From 1 Nov 2020 to the primary completion date, 31 Jan 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance.
- Participants with cognitive impairment will not be included because of expected difficulties in completing the questionnaires without assistance.
Other
- Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
- Partners
- Participants who are not able to read or write Dutch will be excluded, as they are not able to complete a Dutch questionnaire.
Who the study is looking for
- Newly diagnosed with cervical cancer stage I, II or III
- \>18 years or older
- Partner of patient participating in the study
- \>18 years
Criteria the registry did not label
- Patients
Age in the registry: 18 years to - · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amphia Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| MUMC+ Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.