An interventional study of Tele-consultation in Patient Satisfaction and Efficacy of Bowel-preparation and Colon Cancer Prevention, sponsored by National Cancer Institute, Naples. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by National Cancer Institute, Naples · Not applicable, Interventional, and Other
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.
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:
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 534 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects eligible for outpatient pancolonoscopy:
Exclusion Criteria:
Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.
Other: 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
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.
Time frame: 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).
Time frame: baseline, before colonoscopy up to 12 months
Financial Toxicity (FT) using the "PROFFIT questionnaire"
Assessment of FT through PROFFIT questionnaire. This is an Italian instrument for evaluating FT in patients in the Italian healthcare context. It includes 16 total items, 7 measuring FT (defining the PROFFIT financial score) and 9 measuring possible determinants of FT. The score range from 0-100 (the higher value means precence of FT).
Time frame: baseline (before colonoscopy) up to 12 months
Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)
Quality of colonoscopies between patients who received tele-consultation and those who did not receive tele-consultation based on ADR. ADR represents the percentage of patients undergoing colonoscopy in which at least one adenoma is detected.
Time frame: at the end of colonoscopy up to 12 months
Rate of cecal intubation
Cecal intubation rate in patients of the 2 study groups
Time frame: at the end of colonoscopy up to 12 months
Plan to share: No
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National Cancer Institute, Naples