Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
832 participants
OBSERVATIONAL
2020-11-01
2030-01-31
Brief Summary
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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).
Detailed Description
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Study population: Newly diagnosed stage 1-3 cervical cancer patients (N=520) and their partners (N=312, expected) from any treatment centre in the Netherlands will be asked to fill out questionnaires. In a subsample of patients (N=116) additionally lifestyle and biological measures are assessed at all time-points.
Main study parameters/endpoints: psychological distress (anxiety, depression, perceived stress, cancer worry)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients and partners are asked to complete a questionnaire at 6 points in time: after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Patients will additionally be asked to complete an online food diary for 3 days. A subsample of patients will be asked to donate blood samples (2X10 ml, 10 minutes) to assess inflammation markers and telomere length, to donate a scalp hair sample (10 mg) to assess hormone production after diagnosis and after 6, 12 and 24 months, and to wear an Actigraph activity tracker to assess physical activity and sleep and a Philips Biosensor to assess heart rate variability as a marker of vagal nerve function at 6, 12 and 24 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* \>18 years or older
* Partner of patient participating in the study
* \>18 years
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Tilburg University
OTHER
Netherlands Organisation for Scientific Research
OTHER_GOV
Comprehensive Cancer Centre The Netherlands
OTHER
Responsible Party
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Nicole Ezendam
Principal Investigator
Principal Investigators
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Nicole Ezendam
Role: PRINCIPAL_INVESTIGATOR
Netherlands Comprehensive Cancer Organisation
Locations
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Amphia
Breda, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
MUMC
Maastricht, , Netherlands
RadboudUMC
Nijmegen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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R Yigit
Role: primary
Peggy Vos van Steenwijk
Role: primary
Petra Zusterzeel
Role: primary
Eleonora van Dorst, Dr.
Role: primary
Related Links
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https://www.nvog.nl/organisatie/pijler-oncologie/dgog/studies/dice-2/
Other Identifiers
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NL.67509.028.18
Identifier Type: -
Identifier Source: org_study_id