Clinical trial NCT06887244: Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
Official title: Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction and Efficacy of Bowel-preparation
Colon Cancer Prevention
Keywords: colonoscopy
tele-consultation procedure
colon cancer
financial toxicity
anxiety procedure-related
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)
timeFrame: at the end of colonoscopy up to 12 months
measure: H.A.D.S. (Hospital Anxiety and Depression Scale)
timeFrame: baseline, before colonoscopy up to 12 months
Secondary outcomes:
measure: Financial Toxicity (FT) using the "PROFFIT questionnaire"
timeFrame: baseline (before colonoscopy) up to 12 months
measure: Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)
timeFrame: at the end of colonoscopy up to 12 months
measure: Rate of cecal intubation
timeFrame: at the end of colonoscopy up to 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: S.S.D. Garoenterologia ed Endoscopia Digestiva
Study officials:
affiliation: National Cancer Institute, IRCCS Fondazione G. Pascale
name: Francesco De Falco, Nursing degree
role: PRINCIPAL_INVESTIGATOR
References: