Distress In CErvical Cancer Patients and Partners
- Conditions
- Cervical CancerPsychologic StressPsychological DistressSurvivorshipQuality of Life
- Registration Number
- NCT04475354
- Lead Sponsor
- Comprehensive Cancer Centre The Netherlands
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 832
- Newly diagnosed with cervical cancer stage I, II or III
- >18 years or older
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety/ depression 24 months Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
- Secondary Outcome Measures
Name Time Method Cancer worry 24 months Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)
Health-related quality of life 24 months EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)
Cervical cancer health-related quality of life 24 months EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)
Perceived stress 24 months Perceived Stress Scale (0-40, higher scores indicate more perceived stress)
Sexual Health 24 months EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)
Trial Locations
- Locations (6)
Amphia
🇳🇱Breda, Netherlands
MUMC
🇳🇱Maastricht, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
RadboudUMC
🇳🇱Nijmegen, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands