Actively Recruiting

Age: 18Years +
All Genders
NCT04475354

Distress In CErvical Cancer Patients and Partners

Led by Comprehensive Cancer Centre The Netherlands · Updated on 2023-12-06

832

Participants Needed

6

Research Sites

478 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

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

Official Title

Distress In CErvical Cancer Patients and Partners

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed with cervical cancer stage I, II or III
  • 18 years or older
  • Partner of patient participating in the study
  • Partner is 18 years or older
Not Eligible

You will not qualify if you...

  • Cognitive impairment preventing completion of questionnaires without assistance
  • Unable to read or write Dutch

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Amphia

Breda, Netherlands

Actively Recruiting

2

Catharina Hospital

Eindhoven, Netherlands

Actively Recruiting

3

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

4

MUMC

Maastricht, Netherlands

Actively Recruiting

5

RadboudUMC

Nijmegen, Netherlands

Actively Recruiting

6

UMC Utrecht

Utrecht, Netherlands

Actively Recruiting

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Research Team

N

Nicole Ezendam, PhD

CONTACT

B

Belle de Rooij, PhD

CONTACT

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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