Psychological tests administration
OtherPsychological tests administration to evaluate stigma, personality characteristics and quality of life of rectal and anal cancer patients.
NCT Number: NCT06366841
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy
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
Exclusion criteria
Psychological tests administration to evaluate stigma, personality characteristics and quality of life of rectal and anal cancer patients.
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).
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Acronym: SERENA
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