RecruitingNCT04475354

Distress In CErvical Cancer Patients and Partners

Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study


Sponsor

Comprehensive Cancer Centre The Netherlands

Enrollment

832 participants

Start Date

Nov 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Patients
  • Newly diagnosed with cervical cancer stage I, II or III
  • \>18 years or older
  • Partner of patient participating in the study
  • \>18 years

Exclusion Criteria5

  • 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
  • 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.

Locations(6)

Amphia

Breda, Netherlands

Catharina Hospital

Eindhoven, Netherlands

University Medical Center Groningen

Groningen, Netherlands

MUMC

Maastricht, Netherlands

RadboudUMC

Nijmegen, Netherlands

UMC Utrecht

Utrecht, Netherlands

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NCT04475354


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