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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366841
Other study ID # 6439
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 6, 2024
Est. completion date April 30, 2026

Study information

Verified date April 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Loredana Dinapoli
Phone +390630154428
Email loredana.dinapoli@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 148
Est. completion date April 30, 2026
Est. primary completion date April 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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