Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity

March 21, 2025 updated by: National Cancer Institute, Naples

Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity

This is a multicenter, non-pharmacological, experimental, prospective, randomized study, with two arms (1:1) in a single-blind design. The study aims to evaluate the effectiveness of a tele-consultation procedure in patients undergoing elective colonoscopy in terms of quality of the exam, anxiety procedure-related and financial toxicity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effectiveness, in daily clinical practice, of a tele-consultation procedure (defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy) with the goal of:

  1. improving adherence to methods and timing for the correct intake of the intestinal preparation by patients undergoing elective colonoscopy;
  2. assessing whether the tele-consultation can reduce anxiety and procedure-related stress, promoting a better emotional state in patients undergoing colonoscopy.

Study Type

Interventional

Enrollment (Estimated)

534

Phase

  • Not Applicable

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 Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • S.S.D. Garoenterologia ed Endoscopia Digestiva
        • Contact:
        • Contact:
          • Mario De Bellis, MD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects eligible for outpatient pancolonoscopy:

  • for diagnostic purposes;
  • for screening purposes;
  • for post-polypectomy follow-up;
  • of both genders;
  • of all ethnicities;

Exclusion Criteria:

  • Patients under 18 years of age or over 80 years of age;
  • Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days);
  • Patients included in GOM pathways who undergo colonoscopy within 10 days;
  • Pregnancy;
  • Presence of known contraindications to bowel preparation;
  • Presence of known contraindications to performing pancolonoscopy;
  • Patients who have undergone colonic resection and/or have a colostomy/ileostomy;
  • Patients with cognitive impairments;
  • Patients declared legally incompetent or unable to understand and make decisions;
  • Patients unable to provide informed consent.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard arm
Experimental: nurse tele-consultation arm
Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.
Other: Tele-consultation
Tele-consultation procedure is defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)
Time Frame: at the end of colonoscopy up to 12 months
Compare the quality of the colonoscopy between patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the BBPS score (BOSTON BOWEL PREPARATION SCORE). The BBPS score ranges from 0 to 9 based on intestinal preaparation in cecum, colon and rectum. Each section is scored on a scale of 0 to 3 (0= unprepared to 3= excellent). The total BBPS score is the sum of the scores from the three sections (score 0 to 5=Poor preparation; score 6 to 7= fair preparation; score 8 to 9=good preparation). A higher score indicates better bowel preparation, which is ideal for a successful colonoscopy.
at the end of colonoscopy up to 12 months
H.A.D.S. (Hospital Anxiety and Depression Scale)
Time Frame: baseline, before colonoscopy up to 12 months

Compare the quality of the emotional state between the sample of patients who received tele-consultation (INTERVENTION Group) and those who did not receive tele-consultation (CONTROL Group) based on the H.A.D.S. score (Hospital Anxiety and Depression Scale).The scale consists of 14 items, with 7 questions related to anxiety and 7 related to depression. Each item is rated on a 4-point scale (from 0=not at all to 3= most of the time). The total score for each section (anxiety and depression) can range from 0 to 21, and then the scores from both sections are combined for a total score ranging from 0 to 42.

The minimun score is 0-7 that means normal (little to no anxiety or depression). The maximum score is 15-21 that means severe (significant anxiety or depression).
baseline, before colonoscopy up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)
Time Frame: at the end of colonoscopy up to 12 months
Quality of colonoscopies between patients who received tele-consultation and those who did not receive tele-consultation based on ADR. ADR represents the percentage of patients undergoing colonoscopy in which at least one adenoma is detected.
at the end of colonoscopy up to 12 months
Rate of cecal intubation
Time Frame: at the end of colonoscopy up to 12 months
Cecal intubation rate in patients of the 2 study groups
at the end of colonoscopy up to 12 months
Financial Toxicity (FT) using the "PROFFIT questionnaire"
Time Frame: baseline (before colonoscopy) up to 12 months
Assessment of FT through PROFFIT questionnaire. This is an Italian instrument for evaluating FT in patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. The score range from 0-100 (the higher value means precence of FT).
baseline (before colonoscopy) up to 12 months

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Francesco De Falco, Nursing degree, National Cancer Institute, IRCCS Fondazione G. Pascale

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)

June 24, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Registry 26-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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