Fact CheckerSign in

NCT06366841Recruiting

Stigma and Psychological profilE in REctal-anal caNcer pAtients

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
148 (estimated)
First submitted
5 Apr 2024
Start date
6 May 2024
Primary completion date
31 Oct 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06366841

What you commit to

  • Study type: Observational
  • Planned participants: 148
  • From 6 May 2024 to the primary completion date, 31 Oct 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Rectal and anal cancer patients undergoing short-course radiotherapy
  • Rectal and anal cancer patients undergoing palliative radiotherapy
  • Patients with psychopathological disturbances preexisting to the cancer diagnosis

Age

  • Age \> 75 years

Other

  • Patients with inability to express informed consent
  • Patients denying informed consent
  • Patients affected by severe language deficits

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service
Coordinator of this site? Confirm its status
RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.