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Stigma and Psychological profilE in REctal-anal caNcer pAtients

Stigma and Psychological profilE in REctal-anal caNcer pAtients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06366841
Acronym
SERENA
Enrollment
148
Registered
2024-04-16
Start date
2024-05-06
Completion date
2026-08-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer, Rectal Cancer

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.

Interventions

OTHERPsychological tests administration

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of rectal and anal cancer stigma24 monthsPSS (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).

Secondary

MeasureTime frameDescription
Evaluation of psychological characteristics in rectal and anal cancer24 monthsPersonality 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).
Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version24 monthsTemperament 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.
Toronto Alexithymia Scale24 monthsAlexithymia 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.
EORTC QLQ - CR29 and EORTC QLQ-ANL2724 monthsEORTC 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.

Countries

Italy

Contacts

Primary ContactLoredana Dinapoli
loredana.dinapoli@policlinicogemelli.it+390630154428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026