Distress In CErvical Cancer Patients and Partners

Quality of Life Clinical Trial

— DICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475354
• Other study ID #: NL.67509.028.18
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: January 2030

Study information

• Verified date: December 2023
• Source: Comprehensive Cancer Centre The Netherlands
• Contact: Nicole Ezendam, PhD
• Phone: +31 88 234 6096
• Email: N.Ezendam[@]iknl.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 832
• Est. completion date: January 2030
• Est. primary completion date: January 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Psychologic Stress
• Psychological Distress
• Quality of Life
• Stress, Psychological
• Survivorship
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Netherlands	Amphia	Breda
Netherlands	Catharina Hospital	Eindhoven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	MUMC	Maastricht
Netherlands	RadboudUMC	Nijmegen
Netherlands	UMC Utrecht	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
Comprehensive Cancer Centre The Netherlands	Netherlands Organisation for Scientific Research, Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety/ depression	Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)	24 months
Secondary	Cancer worry	Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)	24 months
Secondary	Perceived stress	Perceived Stress Scale (0-40, higher scores indicate more perceived stress)	24 months
Secondary	Health-related quality of life	EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)	24 months
Secondary	Cervical cancer health-related quality of life	EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)	24 months
Secondary	Sexual Health	EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)	24 months

External Links

•   https://www.nvog.nl/organisatie/pijler-oncologie/dgog/studies/dice-2/