Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Psychological Distress | — | UNRESOLVED | — |
| Psychologic Stress | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cervical cancer patients and their partners
- description
- 520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years
Primary outcomes (1)
- measure
- Anxiety/ depression
- timeFrame
- 24 months
- description
- Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
Secondary outcomes (5)
- measure
- Cancer worry
- timeFrame
- 24 months
- description
- Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available