Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tele-consultation.
- Who it may be relevant to
- Registry conditions: Patient Satisfaction and Efficacy of Bowel-preparation, Colon Cancer Prevention. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
Overview
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
- 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
Primary outcome measures
- Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE) [Time frame: at the end of colonoscopy up to 12 months]
- H.A.D.S. (Hospital Anxiety and Depression Scale) [Time frame: baseline, before colonoscopy up to 12 months]
Secondary outcome measures (3)
- Financial Toxicity (FT) using the "PROFFIT questionnaire" [Time frame: baseline (before colonoscopy) up to 12 months]
- Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR) [Time frame: at the end of colonoscopy up to 12 months]
- Rate of cecal intubation [Time frame: at the end of colonoscopy up to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Italy · 1 center
- S.S.D. Garoenterologia ed Endoscopia Digestiva — Naples
Identifiers
NCT: NCT06887244 · Registry 26-23