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Stigma and Psychological profilE in REctal-anal caNcer pAtients

Study acronym: SERENA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Aug 31, 2026 → Oct 31, 2027
See other at-risk trials from Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Aug 31, 2026 to Oct 31, 2027
    • Study completion pushed from Aug 31, 2026 to Jul 1, 2028
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Notable Primary completion date: Apr 30, 2025 to Aug 31, 2026
    • Study completion date: Apr 30, 2026 to Aug 31, 2026
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Apr 15, 2024 to May 6, 2024
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06366841
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Rectal Cancer, Anal Cancer
Related terms Anus Neoplasms, Rectal Neoplasms
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov