Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).

NCT ID: NCT06364579

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2031-01-31

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.

Conditions

Anal Cancer Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) 0-3
• minimum 18 years old
• squamous cell carcinoma of the anal canal
• low burden of metastatic disease at diagnosis
• indication for radiochemotherapy treatment
• informed consent

Exclusion Criteria

• age under 18 years
• Eastern Cooperative Oncology Group (ECOG) higher than 3
• metastatic disease at diagnosis not amenable to radiochemotherapy treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Manfrida Stefania

Radiation oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefania Manfrida

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Manfrida, MD

Role: CONTACT

stefania.manfrida@policlinicogemelli.it

0039 0630154434

Stefania Manfrida

Role: CONTACT

stefania.manfrida@policlinicogemelli.it

+390630155701

Facility Contacts

Stefania Manfrida, MD

Role: primary

stefania.manfrida@policlinicogemelli.it

+3900630154434

Stefania Mandrida

Role: backup

+390630155701

Other Identifiers

6533

Identifier Type: -

Identifier Source: org_study_id