Graphic Novel for Patients Undergoing EUS-FNB

NCT06268106 | Not Yet Recruiting

• 1 other identifier: IRB N/A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety. This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels. Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels. This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment.

Conditions

Anxiety; Pancreatic Cancer; Pancreatic Cystic Lesions; Stress

Outcome Measures

Primary Outcomes (2)

• Anxiety and stress level according to BAI

  Patients will complete the Beck Anxiety Inventory (BAI) to assess anxiety and stress levels. Each variable will be scored accordingly: 0 (not at all) to 3 (severe), with higher scores indicating more severe anxiety. Standardized cut-offs classify anxiety levels as minimal (0-11), mild (12-23), moderate (24-34), or severe (35-42)

  up to hospital discharge, approximately up to 12 hours

• Anxiety and stress level according to mASS-14

  Patients will complete the modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14, to assess anxiety and stress levels. Levels will be classified accordingly: normal (0-4), mild (5-8), moderate (9-11) or severe (12-14)

  up to hospital discharge, approximately up to 12 hours

Study Arms (2)

Standard procedure informative

NO INTERVENTION

Patients in this group undergo procedure with standard explanation of the procedure itself, so they do not receive and visualize graphic novel.

Graphic novel visualization

EXPERIMENTAL

Patients in this group do receive and visualize graphic novel in addition to standard explanation of the procedure.

Behavioral: Graphic novel visualization

Interventions

Graphic novel visualization BEHAVIORAL

Patients in interventional group do receive and visualize graphic novel, which is more informative than standard informed consent.

Graphic novel visualization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• pancreatic solid mass or partially solid in case of cystic component
• agree to participate in the study by signing the informed consent, and the ability to read and understand informed consent
• patients not affected by any known psychological disorder.

You may not qualify if:

• patients with cognitive deficits, such that they cannot adequately complete the questionnaire and the visually impaired
• suspected or obvious pregnancy status in female subjects
• patients using benzodiazepines or other psychotropic medications
• patients with previous diagnosis of cancer.

Sponsors & Collaborators

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: lead

Study Sites (1)

Irccs - Ismett

Palermo, PA, 90127, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Mario Traina, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  STUDY DIRECTOR

• Giacomo Emanuele Maria Rizzo, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  STUDY CHAIR

• Ilaria Tarantino, MD

  The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Emanuele Maria Rizzo, MD

CONTACT

+39 3406602502; grizzo@ismett.edu

Ilaria Tarantino, MD

CONTACT

itarantino@ismett.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Graphic novel will be visualized by interventional group before EUS-FNB

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)