Stigma and Psychological profilE in REctal-anal caNcer pAtients (SERENA)

In 2022, Italy is estimated to have 48,100 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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Anal Cancer
• Intervention / Treatment: Other: Psychological tests administration

• Study Type: Observational
• Enrollment (Estimated): 148

Contacts and Locations

• Study Contact: Name: LOREDANA DINAPOLI; Phone Number: +390630154428; Email: loredana.dinapoli@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: LOREDANA DINAPOLI; Phone Number: +390630154428; Email: loredana.dinapoli@policlinicogemelli.it
    • Principal Investigator: Loredana Dinapoli
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service
    • Principal Investigator: Loredana Dinapoli
    • Contact: LOREDANA DINAPOLI; Phone Number: +390630155701; Email: loredana.dinapoli@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Rectal and anal cancer patients undergoing a long course of radiotherapy

Description

Inclusion Criteria:

Locally advanced rectal and anal cancer patients undergoing a long course of radiotherapy

• Patients in chemo-radiation treatment
• Ability to understand and complete the questionnaires
• Age ≥18 years
• Informed consent signed

Exclusion Criteria:

• Age > 75 years
• Rectal and anal cancer patients undergoing short-course radiotherapy
• Rectal and anal cancer patients undergoing palliative radiotherapy
• Patients with inability to express informed consent
• Patients denying informed consent
• Patients with psychopathological disturbances preexisting to the cancer diagnosis
• Patients affected by severe language deficits

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of rectal and anal cancer stigma	PSS (modified) Perceived Stigma Scale. A self-administered questionnaire to measure perceived stigma through 7 items on a five-point Likert scale (ranging from 0 = never to 4 = always), with a higher score reflecting a greater level of perceived stigma (min score 0 max score 28).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of psychological characteristics in rectal and anal cancer	Personality Inventory for DSM-5 (Diagnostic Statistical Manual of Mental Disorders 5th edition) brief form for adults The Personality Inventory for DSM-5 brief form measures non-adaptive personality traits: Negative Affectivity, Detachment, Antagonism, Disinhibition and Psychoticism (25 items).	24 months
Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version	Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version. is a new self-report measure of the affective temperament with depressive (D), cyclothymic (C), hyperthymic (H), irritable (I), and anxious (A) subscales.	24 months
Toronto Alexithymia Scale	Alexithymia Toronto Scale is a 20-item Likert scale. Within the TAS, there are distinct subscales that focus on specific dimensions of alexithymia: Difficulty Describing Feelings, Difficulty Identifying Feelings, and Externally Oriented Thinking.	24 months
EORTC QLQ - CR29 and EORTC QLQ-ANL27	EORTC QLQ - CR29 and EORTC QLQ-ANL27 Quality of life in rectal and anal cancer submodules specifically assess colon-rectal and anal cancer. Raw scores for each scale are linear transformed into a 0-100 outcome. A higher functioning score indicated better functioning or global health/QoL, whereas higher symptom scores indicate a higher level of symptom severity.	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Loredana Dinapoli, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Anus Diseases; Rectal Neoplasms; Anus Neoplasms
• Other Study ID Numbers: 6439

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No