Stigma and Psychological profilE in REctal-anal caNcer pAtients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients in chemo-radiation treatment

Ability to understand and complete the questionnaires

Age ≥18 years

Informed consent signed

Disqualifiers

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

Trial population

Rectal and anal cancer patients undergoing a long course of radiotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Psychological tests administration

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Evaluation of rectal and anal cancer stigma

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

Secondary outcomes

1

Evaluation of psychological characteristics in rectal and anal cancer

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
2

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

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
3

Toronto Alexithymia Scale

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
4

EORTC QLQ - CR29 and EORTC QLQ-ANL27

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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