Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364579
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-28
Brief Title:
Patient Reported Outcomes PROs in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy IMRT
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Patient Reported Outcomes PROs in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy IMRT
Status:
RECRUITING
Status Verified Date:
2024-03
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:
PROACT
Brief Summary:
Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter However patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal anal sphincter and sexual level Few studies to date have documented patient-reported outcomes PROs in this area The aim of this observational study is to verify the quality of life QOL of the patients by means of self-completed questionnaires
Detailed Description:
In recent times the focus on collecting patient-reported outcomes PROs has increased in healthcare The Food and Drug Administration defines PROs as a -measurement of any aspect of a health status of the patient that comes directly from the patient- These includes disease symptoms functional aspects and quality of life QOL The collection of PROs combined with physician-assessed toxicity is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions Although the use of PROs has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term QOL of anal cancer patients and on disease or therapy related symptoms that affect QOL Therefore the EORTC European Organisation for Research and Treatment of Cancer has recently developed the specific Quality of Life Questionnaire for anal cancer QLQ-AN27 module to explore typical symptoms of anal cancer and its therapy In this study the QLQ-AN27 questionnaire will be administered together with the EORTC Quality of Life 30 QLQ 30 in patients with anal cancer who have undergone radio-chemotherapy The questionnaire may be administered before treatment after treatment and during follow-ups until completion of the fifth year This is an observational study both retrospective and prospective
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