Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05122052
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2021-11-04
Brief Title:
Effect of Gender on Distress and Fatigue in Cancer Patients
Sponsor:
Ente Ospedaliero Ospedali Galliera
Organization:
Ente Ospedaliero Ospedali Galliera
Study Overview
Official Title:
Effect of Gender on Distress and Fatigue Over Time in Cancer Patients A Prospective Longitudinal Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
Distress in cancer patients has been shown to be higher in females than males but the behavior of distress during time in longitudinal prospective studies has not been studied nor is it known if there are differences related to gender during time These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories
The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women We will also investigate if psychological factors distress anxiety and depression affected antibody response and markers of COVID-19 vaccine activation C-reactive protein CRP and D-dimer after 6 months from initial vaccination
Caregivers will also be interviewed to measure their burden with the Zarit Burden Interview
Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions
The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women We will also investigate if psychological factors distress anxiety and depression affected antibody response and markers of COVID-19 vaccine activation C-reactive protein CRP and D-dimer after 6 months from initial vaccination
Caregivers will also be interviewed to measure their burden with the Zarit Burden Interview
Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions
Detailed Description:
Distress and fatigue in cancer patients are important factors affecting treatment compliance and efficacy and quality of life The prevalence of moderate or severe emotional distress in cancer patients ranges from 30 to 45 depending on a point of assessment The National Comprehensive Cancer Network indicates that all cancer patients should undergo a distress measurement as the sixth vital parameter to prevent more serious psychological disorders including anxiety depression and coping disturbances Several studies indicate that patients undergoing psychotherapy or psychosocial support to relieve cancer distress have better disease coping a reduction of fatigue anxiety and depression and an improvement in quality of live and possibly survival
Distress in cancer patients has been shown to be higher in females than males but the behavior of distress during time in longitudinal prospective studies has not been studied nor is it known if there are differences related to gender during time These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories
The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women
In a subset of patients we will also investigate if psychological factors distress anxiety and depression affected antibody response and markers of COVID-19 vaccine activation C-reactive protein CRP and D-dimer after 6 months from initial vaccination
Caregivers will also be interviewed with the Zarit questionnaire a popular caregiver self-report measure used by many aging agencies originated as a 29-item questionnaire The 29-item instrument is included in Zarit et al 1980 Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale Response options range from 0 Never to 4 Nearly Always
Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions
Distress in cancer patients has been shown to be higher in females than males but the behavior of distress during time in longitudinal prospective studies has not been studied nor is it known if there are differences related to gender during time These differences may have important therapeutic implications in terms of selective psychological support as cancer progresses during individual trajectories
The aim of the present study is to examine the effect of gender during time on psychological distress and fatigue in cancer patients across a broad range of cancer types It is hypothesized that women will report higher psychological distress than men at initial visit but a reversed trend will be observed during follow-up as a result of different coping capabilities between men and women
In a subset of patients we will also investigate if psychological factors distress anxiety and depression affected antibody response and markers of COVID-19 vaccine activation C-reactive protein CRP and D-dimer after 6 months from initial vaccination
Caregivers will also be interviewed with the Zarit questionnaire a popular caregiver self-report measure used by many aging agencies originated as a 29-item questionnaire The 29-item instrument is included in Zarit et al 1980 Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale Response options range from 0 Never to 4 Nearly Always
Patients attending a cancer outpatient clinic are invited to undergo a psychological session immediately before the medical visit Distress is assessed by the Distress thermometer and fatigue by the ESAS-r scale at the end of the session Patients will undergo follow-up visits to assess changes during time and possible time by gender interactions
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