Distress In CErvical Cancer Patients and Partners
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
Overview
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).
Detailed description
Study design: Prospective population-based study in which cervical cancer patients and their partners are included shortly after diagnosis and followed until 10 years after diagnosis. Patients from treatment centres in the Netherlands and their partners will be asked to complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Clinical data like disease stage, initial treatment and mortality will be extracted from the Netherlands Cancer Registry. In a subsample of patients, additionally objective lifestyle (actigraph, biosensor) and biological (blood, hair) measures are assessed at diagnosis and after 6, 12 and 24 months. .
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.
Primary outcome measures
- Anxiety/ depression [Time frame: 24 months]
Secondary outcome measures (5)
- Cancer worry [Time frame: 24 months]
- Perceived stress [Time frame: 24 months]
- Health-related quality of life [Time frame: 24 months]
- Cervical cancer health-related quality of life [Time frame: 24 months]
- Sexual Health [Time frame: 24 months]
Eligibility criteria
Patients
Inclusion criteria
- Newly diagnosed with cervical cancer stage I, II or III
- >18 years or older
Exclusion criteria
- 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
Inclusion criteria
- Partner of patient participating in the study
- >18 years
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 6 centers
- Amphia — Breda
- Catharina Hospital — Eindhoven
- University Medical Center Groningen — Groningen
- MUMC — Maastricht
- RadboudUMC — Nijmegen
- UMC Utrecht — Utrecht
Identifiers
NCT: NCT04475354 · NL.67509.028.18