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NCT Number: NCT06366841

Stigma and Psychological profilE in REctal-anal caNcer pAtients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological tests administration

Other

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

Primary outcomes

  1. Evaluation of rectal and anal cancer stigma

    Time frame: 24 months

    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).

Secondary outcomes

  1. Evaluation of psychological characteristics in rectal and anal cancer

    Time frame: 24 months

    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).

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

    Time frame: 24 months

    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.

  3. Toronto Alexithymia Scale

    Time frame: 24 months

    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.

  4. EORTC QLQ - CR29 and EORTC QLQ-ANL27

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Loredana Dinapoli

CONTACT

[email protected]

+390630154428

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: SERENA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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