Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124040
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-10-24
Brief Title:
Sexual Function Coping and Dyadic Coping in Patients With Cervical Cancer
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Sexual Function Coping and Dyadic Coping in Cervical Cancer Patients a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
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:
SUCCEEDER
Brief Summary:
The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous and their results are often conflicting therefore no definitive recommendations can be formulated Furthermore it is unclear whether the dysfunction is attributable to surgical sequelae radiotherapy chemotherapy or psychological aspects related to cancer Moreover a baseline evaluation about sexual function and coping if often lacking
Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs radio-chemotherapy cervical cancer patients with the following objectives
To assess sexual function coping emotional distress and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy
To evaluate changes on the previous variables over 6 months
The results obtained will be utilized for
planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients
Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs radio-chemotherapy cervical cancer patients with the following objectives
To assess sexual function coping emotional distress and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy
To evaluate changes on the previous variables over 6 months
The results obtained will be utilized for
planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients
Detailed Description:
Many recent reviews focused on QoL and the sexual function of patients with cervical cancer and have only evaluated the sexual dysfunctions of patients undergoing chemo-radiotherapy plus interventional radiotherapy
The studies currently available in the literature are poor and heterogeneous and their results are often conflicting therefore no definitive recommendations can be formulated Furthermore it is unclear whether the dysfunction is attributable to surgical sequelae radiotherapy chemotherapy or psychological aspects related to cancer In fact psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer
Common psychological issues included poor body image decreased sense of femininity anxiety about sexual interactions and pain
Consequently related social issues may emerge for example the ability to maintain a sexual relationship communication difficulties and adverse effects on intimate relationships
Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease andor its treatment The most important classification for cervical cancer is FIGO International Federation Gynecology and Obstetrics updated in 2021 Treatments for cervical cancer are different depending on this classification Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers surgery vs chemoradiation plus interventional radiotherapy both types can have a major impact on patients sexual function and coping also dyadic coping since diagnosis
For this reason we decided to perform a prospective longitudinal study to compare surgical vs radio-chemotherapy cervical cancer patients with the following objectives
Primary objectives to assess sexual function and coping Secondary objective to evaluate emotional distress dyadic coping anxiety and depression QoL of patients with cervical cancer association between coping and possible dissociative symptoms changes on the previous variables over 6 months
The studies currently available in the literature are poor and heterogeneous and their results are often conflicting therefore no definitive recommendations can be formulated Furthermore it is unclear whether the dysfunction is attributable to surgical sequelae radiotherapy chemotherapy or psychological aspects related to cancer In fact psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer
Common psychological issues included poor body image decreased sense of femininity anxiety about sexual interactions and pain
Consequently related social issues may emerge for example the ability to maintain a sexual relationship communication difficulties and adverse effects on intimate relationships
Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease andor its treatment The most important classification for cervical cancer is FIGO International Federation Gynecology and Obstetrics updated in 2021 Treatments for cervical cancer are different depending on this classification Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers surgery vs chemoradiation plus interventional radiotherapy both types can have a major impact on patients sexual function and coping also dyadic coping since diagnosis
For this reason we decided to perform a prospective longitudinal study to compare surgical vs radio-chemotherapy cervical cancer patients with the following objectives
Primary objectives to assess sexual function and coping Secondary objective to evaluate emotional distress dyadic coping anxiety and depression QoL of patients with cervical cancer association between coping and possible dissociative symptoms changes on the previous variables over 6 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