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Идёт набор NCT06366841

Stigma and Psychological profilE in REctal-anal caNcer pAtients

— Наблюдательное Rectal Cancer Anal Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychological tests administration.
Кому может быть актуально
Состояния в реестре: Rectal Cancer, Anal Cancer. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Evaluation of rectal and anal cancer stigma [Срок оценки: 24 months]
Вторичные конечные точки (4)
  • Evaluation of psychological characteristics in rectal and anal cancer [Срок оценки: 24 months]
  • Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version [Срок оценки: 24 months]
  • Toronto Alexithymia Scale [Срок оценки: 24 months]
  • EORTC QLQ - CR29 and EORTC QLQ-ANL27 [Срок оценки: 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 2 центра
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service — Roma
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Идентификаторы

NCT: NCT06366841 · 6439

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗