Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04475354
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2020-01-16
Brief Title:
Distress In CErvical Cancer Patients and Partners
Sponsor:
Comprehensive Cancer Centre The Netherlands
Organization:
Comprehensive Cancer Centre The Netherlands
Study Overview
Official Title:
Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners DICE a Population-based Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DICE
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 ie 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
Objective Gain insight into the mechanisms explaining psychological distress ie 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 N520 and their partners N312 expected from any treatment centre in the Netherlands will be asked to fill out questionnaires In a subsample of patients N116 additionally lifestyle and biological measures are assessed at all time-points
Main study parametersendpoints 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
Study population Newly diagnosed stage 1-3 cervical cancer patients N520 and their partners N312 expected from any treatment centre in the Netherlands will be asked to fill out questionnaires In a subsample of patients N116 additionally lifestyle and biological measures are assessed at all time-points
Main study parametersendpoints 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None