Stigma and Psychological profilE in REctal-anal caNcer pAtients (SERENA)

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Loredana Dinapoli
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Psychology service
        • Principal Investigator:
          • Loredana Dinapoli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Rectal and anal cancer patients undergoing a long course of radiotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of rectal and anal cancer stigma
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).
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of psychological characteristics in rectal and anal cancer
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).
24 months
Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version
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.
24 months
Toronto Alexithymia Scale
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.
24 months
EORTC QLQ - CR29 and EORTC QLQ-ANL27
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Loredana Dinapoli, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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