Cervical CancerDICENCT04475354
Distress In CErvical Cancer Patients and Partners
An observational study of Cervical Cancer and Psychologic Stress, run by Comprehensive Cancer Centre The Netherlands at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Psychologic Stress, Psychological Distress
- How many people
- 832 participants
- Where
- 6 sitesNetherlands
- Study dates
- 1 Nov 2020to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Newly diagnosed with cervical cancer stage I, II or III
- >18 years or older
- Partner of patient participating in the study
- >18 years
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Amphia
Breda
- Recruiting
Catharina Hospital
Eindhoven
- Recruiting
University Medical Center Groningen
Groningen
R Yigit
- Recruiting
MUMC
Maastricht
Peggy Vos van Steenwijk
- Recruiting
RadboudUMC
Nijmegen
Petra Zusterzeel
- Recruiting
UMC Utrecht
Utrecht
Eleonora van Dorst, Dr.
About this study
Official title: Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
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).
Read the 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.
- Conditions
- Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship, Quality of Life
- Medical subject headings
- Uterine Cervical Neoplasms, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety/ depression
Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
Measured: 24 months
Secondary outcomes (5)
Cancer worry
Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)
Measured: 24 months
Perceived stress
Perceived Stress Scale (0-40, higher scores indicate more perceived stress)
Measured: 24 months
Health-related quality of life
EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)
Measured: 24 months
Cervical cancer health-related quality of life
EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)
Measured: 24 months
Sexual Health
EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Nov 2020
- Primary completionJan 2024 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comprehensive Cancer Centre The Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Nicole Ezendam, Comprehensive Cancer Centre The Netherlands
- Investigators
- Nicole Ezendam, Principal investigator, Netherlands Comprehensive Cancer Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475354
- Sponsor's protocol ID
- NL.67509.028.18
- Acronym
- DICE
- Status last verified
- Dec 2023
- First submitted
- 16 Jan 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
- ClinicalTrials.gov ID
- NCT04475354
- Acronym / sponsor ID
- DICE / NL.67509.028.18
- Conditions
- Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- Comprehensive Cancer Centre The NetherlandsUniversity, hospital or other
- Collaborators
- Tilburg University, Netherlands Organisation for Scientific Research
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Newly diagnosed with cervical cancer stage I, II or III
- >18 years or older
- Partner of patient participating in the study
- >18 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety/ depression
Time frame: 24 months
Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- https://www.nvog.nl/organisatie/pijler-oncologie/dgog/studies/dice-2/Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Ezendam principal investigator
Netherlands Comprehensive Cancer Organisation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Psychologic Stress, run by Comprehensive Cancer Centre The Netherlands at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Ezendam, PhD (+31 88 234 6096, N.Ezendam@iknl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety/ depression (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.