Clinical trial NCT04475354: Distress In CErvical Cancer Patients and Partners
Official title: Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Psychologic Stress
Psychological Distress
Survivorship
Quality of Life
Lead sponsor: Comprehensive Cancer Centre The Netherlands
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: Netherlands Organisation for Scientific Research
First posted: 2020-07-17
Enrollment: 832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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).

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.

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.

Primary outcomes:
measure: Anxiety/ depression
timeFrame: 24 months
Secondary outcomes:
measure: Cancer worry
timeFrame: 24 months
measure: Perceived stress
timeFrame: 24 months
measure: Health-related quality of life
timeFrame: 24 months
measure: Cervical cancer health-related quality of life
timeFrame: 24 months
measure: Sexual Health
timeFrame: 24 months
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: MUMC
city: Nijmegen
country: Netherlands
facility: RadboudUMC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Netherlands Comprehensive Cancer Organisation
name: Nicole Ezendam
role: PRINCIPAL_INVESTIGATOR
References: