Clinical Trials in Italy / NCT06887244
Recruiting
Not applicable
Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
NCT06887244 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Patient Satisfaction and Efficacy of Bowel-preparationColon Cancer Prevention
Investigational drug(s) / intervention(s)
Tele-consultation
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
Study 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.
Eligibility
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 outcome measure(s)
- Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE) — 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. - H.A.D.S. (Hospital Anxiety and Depression Scale) — 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| S.S.D. Garoenterologia ed Endoscopia Digestiva | Naples | Italy | Recruiting |
More National Cancer Institute, Naples trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06887244 on ClinicalTrials.gov ↗ ← All trials in Italy