Stigma and Psychological profilE in REctal-anal caNcer pAtients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological tests administration.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Anal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Psychological tests administration
Psychological tests administration to evaluate stigma, personality characteristics and quality of life of rectal and anal cancer patients.
Primary outcome measures
- Evaluation of rectal and anal cancer stigma [Time frame: 24 months]
Secondary outcome measures (4)
- Evaluation of psychological characteristics in rectal and anal cancer [Time frame: 24 months]
- Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version [Time frame: 24 months]
- Toronto Alexithymia Scale [Time frame: 24 months]
- EORTC QLQ - CR29 and EORTC QLQ-ANL27 [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service — Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Identifiers
NCT: NCT06366841 · 6439