Clinical trial NCT06366841: Stigma and Psychological profilE in REctal-anal caNcer pAtients
Official title: Stigma and Psychological profilE in REctal-anal caNcer pAtients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Anal Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal and anal cancer patients undergoing a long course of radiotherapy

Brief summary: 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: 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

Primary outcomes:
measure: Evaluation of rectal and anal cancer stigma
timeFrame: 24 months
Secondary outcomes:
measure: Evaluation of psychological characteristics in rectal and anal cancer
timeFrame: 24 months
measure: Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version
timeFrame: 24 months
measure: Toronto Alexithymia Scale
timeFrame: 24 months
measure: EORTC QLQ - CR29 and EORTC QLQ-ANL27
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Loredana Dinapoli
role: PRINCIPAL_INVESTIGATOR
References: