Colon Cancer Prevention, Patient Satisfaction and Efficacy of Bowel-preparation
Conditions
Keywords
colonoscopy, tele-consultation procedure, colon cancer, financial toxicity, anxiety procedure-related
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.
Interventions
OTHERTele-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
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Financial Toxicity (FT) using the PROFFIT questionnaire | baseline (before colonoscopy) up to 12 months | 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). |
| Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR) | at the end of colonoscopy up to 12 months | 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. |
| Rate of cecal intubation | at the end of colonoscopy up to 12 months | Cecal intubation rate in patients of the 2 study groups |
Countries
Italy
Contacts
Primary ContactFrancesco De Falco, Nursing degree
Outcome results
None listed