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Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity

N

National Cancer Institute, Naples

Status

Enrolling

Conditions

Colon Cancer Prevention
Patient Satisfaction and Efficacy of Bowel-preparation

Treatments

Other: Tele-consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT06887244
Registry 26-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

534 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

534 participants in 2 patient groups

nurse tele-consultation arm
Experimental group
Description:
Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure.
Treatment:
Other: Tele-consultation
Standard arm
No Intervention group

Trial contacts and locations

1

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Central trial contact

Francesco De Falco, Nursing degree

Data sourced from clinicaltrials.gov

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