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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nurse tele-consultation arm | Experimental | Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure. |
|
| Standard arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-consultation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | baseline, before colonoscopy up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline (before colonoscopy) up to 12 months |
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Inclusion Criteria:
Subjects eligible for outpatient pancolonoscopy:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco De Falco, Nursing degree | Contact | 0811770813 | 0039 | endoscopia@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco De Falco, Nursing degree | National Cancer Institute, IRCCS Fondazione G. Pascale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.S.D. Garoenterologia ed Endoscopia Digestiva | Recruiting | Naples | 80131 | Italy |
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| 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. | at the end of colonoscopy up to 12 months |
| Rate of cecal intubation | Cecal intubation rate in patients of the 2 study groups | at the end of colonoscopy up to 12 months |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D003110 | Colonic Neoplasms |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
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