NCT04475354 Distress In CErvical Cancer Patients and Partners
| NCT ID | NCT04475354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comprehensive Cancer Centre The Netherlands |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 832 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2024-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 832 participants in total. It began in 2020-11-01 with a primary completion date of 2024-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Nicole Ezendam
PRINCIPAL INVESTIGATOR
Netherlands Comprehensive Cancer Organisation
Frequently Asked Questions
Who can join the NCT04475354 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04475354 currently recruiting?
Yes, NCT04475354 is actively recruiting participants. Contact the research team at N.Ezendam@iknl.nl for enrollment information.
Where is the NCT04475354 trial being conducted?
This trial is being conducted at Breda, Netherlands, Eindhoven, Netherlands, Groningen, Netherlands, Maastricht, Netherlands and 2 additional locations.
Who is sponsoring the NCT04475354 clinical trial?
NCT04475354 is sponsored by Comprehensive Cancer Centre The Netherlands. The principal investigator is Nicole Ezendam at Netherlands Comprehensive Cancer Organisation. The trial plans to enroll 832 participants.
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