DICE

Mechanisms of psychological Distress In CErvical cancer patients and partners (DICE): a population-based prospective study.

Samenvatting

Background: 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.

Hypothese

Aims: This study aims to 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, vagal nerve function measured by Philips Biosensor), 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). Secondary, we aim to assess the impact of cervical cancer on partners’ distress (cancer worry, illness perceptions, relationship quality, dyadic coping).

Eindpunten

Psychological distress (anxiety, depression, perceived stress, cancer worry)

Inclusie criteria

In order to be eligible to participate in this study, a patient must meet all of the following criteria:

  • Newly diagnosed with cervical cancer stage I, II or III
  • 18 years or older

In order to be eligible to participate in this study, a partner must meet all of the following criteria:

  • 18 years or older

Exclusie criteria

A potential subject who meets one of the following criteria will be excluded from participation in this study:

  • 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.

Randomisatie

Study design: Prospective population-based study in which we include cervical cancer patients and their partners shortly after diagnosis and follow them 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, we will additionally assess objective lifestyle (actigraph, biosensor) and biological (blood, hair) measures at all time-points.

Flowchart behandeling

NA

Follow-up schema

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. A subsample of patients will be asked to donate blood samples) to assess inflammation markers and telomere length, to donate a scalp hair sample 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. Patients are also asked to complete an online food diary for 3 days. Not all patients are asked to participate in all study facets.

Aanvullende onderzoeken bij randomisatie of tijdens de studie

NA

Verwachte aantal patiënten

520 patiënten; 312 partners (verwacht)

Accrual

0

Contactgegevens

  1. Nicole Ezendam
    Integraal Kankercentrum Nederland
    n.ezendam@iknl.nl
  1. Lonneke van de Poll-Franse
    Integraal Kankercentrum Nederland
    l.vandepoll@iknl.nl
  1. Belle de Rooij
    Integraal Kankercentrum Nederland
    b.derooij@iknl.nl

Vermelding in trialregister, bv

CCMO: https://www.toetsingonline.nl/to/ccmo_search.nsf/searchform?OpenForm
Nederlands Trialregister: www.trialregister.nl
Trialregister (Engels): http://www.clinicaltrials.gov
CCMO: NL67509.028.18

Sponsor: Integraal Kankercentrum Nederland
24 juni 2019