Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366841
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-05
Brief Title:
Stigma and Psychological profilE in REctal-anal caNcer pAtients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Stigma and Psychological profilE in REctal-anal caNcer pAtients
Status:
RECRUITING
Status Verified Date:
2024-04
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:
SERENA
Brief Summary:
In 2022 Italy is estimated to have 48100 cases of colon-rectum cancer Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine The diagnosis and treatment of rectal cancer have a significant impact on patients well-being causing physical and psychological distress Symptoms such as abdominal pain fatigue diarrhea are commonly reported While distress levels have been examined before the relationship between other aspects of the patient experience such as psychosocial factors stigma temperament and personality alexithymia have not been extensively explored Colorectal cancer is associated with specific socially stigmatized challenges Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation leading to discrimination and loss of social status Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms colonoscopy or rectal examinations physical limitations loss of work ability and the use of colostomy or ileostomy Anal cancer although traditionally surrounded by social stigma is gaining awareness worldwide due to increasing diagnoses In other forms of cancer stigma has been linked to personality traits Given the characteristics related to the illness and the profile of rectal and anal cancer patients it is important to assess the psychological traits and psychological resources also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery Currently there is no documented data on the relationship between stigma and psychological profiles in rectal and anal cancer patients Aim of this protocol is to evaluate the stigma and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time
Detailed Description:
None
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