Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-relate… (NCT06887244) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
Italy534 participantsStarted 2024-06-24
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)
Timeframe: at the end of colonoscopy up to 12 months
2
H.A.D.S. (Hospital Anxiety and Depression Scale)
Timeframe: baseline, before colonoscopy up to 12 months