Stigma and Psychological profilE in REctal-anal caNcer pAtients

NCT06366841 | Recruiting

• 1 other identifier: 6439
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rectal Cancer; Anal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of psychological characteristics in rectal and anal cancer

  24 months

• Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version

  24 months

• Toronto Alexithymia Scale

  24 months

• EORTC QLQ - CR29 and EORTC QLQ-ANL27

  24 months

Interventions

Psychological tests administration OTHER

Psychological tests administration to evaluate stigma, personality characteristics and quality of life of rectal and anal cancer patients.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rectal and anal cancer patients undergoing a long course of radiotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service

Roma, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Anus Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases

Study Officials

• Loredana Dinapoli

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loredana Dinapoli

CONTACT

+390630154428; loredana.dinapoli@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 16, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (2)