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

NCT06887244 | Recruiting

• 1 other identifier: Registry 26-23
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction and Efficacy of Bowel-preparation; Colon Cancer Prevention

Keywords

colonoscopy; tele-consultation procedure; colon cancer; financial toxicity; anxiety procedure-related

Outcome Measures

Primary Outcomes (2)

• Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)

  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)

  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 Outcomes (3)

• Financial Toxicity (FT) using the "PROFFIT questionnaire"

  baseline (before colonoscopy) up to 12 months

• Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)

  at the end of colonoscopy up to 12 months

• Rate of cecal intubation

  at the end of colonoscopy up to 12 months

Study Arms (2)

nurse tele-consultation arm

EXPERIMENTAL

Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.

Other: Tele-consultation

Standard arm

NO INTERVENTION

Interventions

Tele-consultation OTHER

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

nurse tele-consultation arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for outpatient pancolonoscopy:
• for diagnostic purposes;
• for screening purposes;
• for post-polypectomy follow-up;
• of both genders;
• of all ethnicities;

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

S.S.D. Garoenterologia ed Endoscopia Digestiva

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Colonic Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stress, Psychological; Behavioral Symptoms

Study Officials

• Francesco De Falco, Nursing degree

  National Cancer Institute, IRCCS Fondazione G. Pascale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco De Falco, Nursing degree

CONTACT

0811770813; endoscopia@istitutotumori.na.it

Study Design

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

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: June 24, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)