NCT06366841 Stigma and Psychological profilE in REctal-anal caNcer pAtients
| NCT ID | NCT06366841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 148 participants in total. It began in 2024-05-06 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Loredana Dinapoli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06366841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06366841 currently recruiting?
Yes, NCT06366841 is actively recruiting participants. Contact the research team at loredana.dinapoli@policlinicogemelli.it for enrollment information.
Where is the NCT06366841 trial being conducted?
This trial is being conducted at Roma, Italy, Roma, Italy.
Who is sponsoring the NCT06366841 clinical trial?
NCT06366841 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Loredana Dinapoli at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 148 participants.
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