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Mechanisms Explaining Psychological Distress in Cervical Cancer Patients and Partners (DICE): A Population-Based Prospective Study
Led by Comprehensive Cancer Centre The Netherlands · Updated on 2023-12-06
832
Participants Needed
6
Research Sites
313 weeks
Total Duration
On this page
Sponsors
C
Comprehensive Cancer Centre The Netherlands
Lead Sponsor
T
Tilburg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying psychological distress in cervical cancer patients and their partners to understand why some patients experience ongoing anxiety, depression, cancer worry, and stress after diagnosis. This prospective population-based study focuses on various factors including personal, clinical, and environmental characteristics, as well as biological functions like hormone levels and inflammation. The study also aims to assess the impact of cervical cancer on partners' psychological distress and relationship quality. The study includes newly diagnosed cervical cancer patients (stage 1-3) and their partners from treatment centers in the Netherlands. Participants complete questionnaires shortly after diagnosis and at 6 months, 1, 2, 5, and 10 years. A subset of patients also provide blood and scalp hair samples and wear activity trackers to measure physical activity, sleep, and heart rate variability at diagnosis and at 6, 12, and 24 months. Participants will fill out questionnaires about psychological distress, health quality, and sexual health at multiple timepoints. Patients complete an online food diary for 3 days and provide biological samples for inflammation and hormone analysis. Physical activity and sleep are tracked using wearable devices. The study monitors anxiety and depression primarily at 24 months, with ongoing follow-up for 10 years to better understand long-term psychological outcomes and quality of life.
CONDITIONS
Brief Title
Distress In CErvical Cancer Patients and Partners
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with cervical cancer stage I, II, or III
- 18 years of age or older
- Partner of a patient participating in the study (for partners)
You will not qualify if you...
- Cognitive impairment preventing completion of questionnaires without assistance
- Unable to read or write Dutch, making questionnaire completion impossible
AI-Screening
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Your Study Journey
Duration - Shortly after diagnosis
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility and initial questionnaire completion
Duration - At diagnosis
Participants complete baseline questionnaires and provide biological samples or wear monitoring devices as part of baseline assessments in a subsample.
1 baseline visit for questionnaire, online food diary, and for subsample blood and hair samples collection, and device fitting
Duration - Up to 10 years after diagnosis
Participants complete follow-up questionnaires at multiple timepoints and subsample participants provide repeated biological samples and wear monitoring devices.
Questionnaire completion at 6 months, 1, 2, 5, and 10 years; subsample provides blood and hair samples and wears devices at 6, 12, and 24 months
Trial Site Locations
Total: 6 locations
1
Amphia
Breda, Netherlands
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2
Catharina Hospital
Eindhoven, Netherlands
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3
University Medical Center Groningen
Groningen, Netherlands
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4
MUMC
Maastricht, Netherlands
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5
RadboudUMC
Nijmegen, Netherlands
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6
UMC Utrecht
Utrecht, Netherlands
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Research Team
N
Nicole Ezendam, PhD
B
Belle de Rooij, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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