Distress In CErvical Cancer Patients and Partners
DICE
Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
1 other identifier
observational
832
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 17, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
ExpectedDecember 6, 2023
December 1, 2023
3.2 years
January 16, 2020
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety/ depression
Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
24 months
Secondary Outcomes (5)
Cancer worry
24 months
Perceived stress
24 months
Health-related quality of life
24 months
Cervical cancer health-related quality of life
24 months
Sexual Health
24 months
Study Arms (1)
Cervical cancer patients and their partners
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
Eligibility Criteria
All newly diagnosed I-III stage cervical cancer patients that receive primary treatment in one of the treatment centres will be identified by their treating gynaecologist. Patients will be invited before the start of treatment and will be followed until 10 years after diagnosis. Additionally, patients will be asked to invite their partner to participate.
You may qualify if:
- Newly diagnosed with cervical cancer stage I, II or III
- \>18 years or older
You may not qualify if:
- 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
- Partner of patient participating in the study
- \>18 years
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Comprehensive Cancer Centre The Netherlandslead
- Tilburg Universitycollaborator
- Netherlands Organisation for Scientific Researchcollaborator
Study Sites (6)
Amphia
Breda, Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
MUMC
Maastricht, Netherlands
RadboudUMC
Nijmegen, Netherlands
UMC Utrecht
Utrecht, Netherlands
Related Links
Biospecimen
Blood: pro-and anti-inflammatory cytokines, telomere length Scalp hair: cortisol, melatonin
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Ezendam
Netherlands Comprehensive Cancer Organisation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 16, 2020
First Posted
July 17, 2020
Study Start
November 1, 2020
Primary Completion
January 1, 2024
Study Completion (Estimated)
January 1, 2030
Last Updated
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Questionnaire data will be dissiminated 1 year after conclusion of the study. Data from the PROFILES registry are freely available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profileregistry.nl).