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
- Diseases
- Colorectal cancer
- 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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.