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Distress In CErvical Cancer Patients and Partners

NCT04475354 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 832

Last updated 2023-12-06

No results posted yet for this study

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).

Conditions

  • Cervical Cancer
  • Psychologic Stress
  • Psychological Distress
  • Survivorship
  • Quality of Life

Sponsors & Collaborators

  • Tilburg University

    collaborator OTHER

  • Netherlands Organisation for Scientific Research

    collaborator OTHER_GOV

  • Comprehensive Cancer Centre The Netherlands

    lead OTHER

Principal Investigators

  • Nicole Ezendam · Netherlands Comprehensive Cancer Organisation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2024-01-31
Completion
2030-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475354 on ClinicalTrials.gov