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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patient Satisfaction and Efficacy of Bowel-preparation Colon Cancer Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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nurse tele-consultation arm

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

Group Type EXPERIMENTAL

Tele-consultation

Intervention Type 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

Standard arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No