Distress In CErvical Cancer Patients and Partners

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Psychologic Stress, Psychological Distress, Survivorship, Quality of Life

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical cancer patients and their partners<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety/ depression | Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer worry | Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry) | 24 months | 
| Perceived stress | Perceived Stress Scale (0-40, higher scores indicate more perceived stress) | 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) | 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) | 24 months | 
| Sexual Health | EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms) | 24 months |