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临床试验/NCT06366841
NCT06366841招募中不适用

Stigma and Psychological profilE in REctal-anal caNcer pAtients

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
148
试验地点
2
主要终点
Evaluation of rectal and anal cancer stigma

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Evaluation of rectal and anal cancer stigma

时间窗: 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).

次要结局

  • Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version(24 months)
  • Toronto Alexithymia Scale(24 months)
  • Evaluation of psychological characteristics in rectal and anal cancer(24 months)
  • EORTC QLQ - CR29 and EORTC QLQ-ANL27(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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