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NCT Number: NCT06887244

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

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.

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Key information

Conditions

Patient Satisfaction and Efficacy of Bowel-preparation Behavior Behavioral Symptoms Colon Cancer Prevention Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Financial Stress Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Satisfaction Stress, Psychological Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.S.D. Garoenterologia ed Endoscopia Digestiva

Naples, 80131, Italy

Location status: Recruiting

Location contact

Francesco De Falco, Nursing degree

CONTACT

[email protected]

08117770813 ext. 0039

Mario De Bellis, MD

SUB_INVESTIGATOR

About this study

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:

  • improving adherence to methods and timing for the correct intake of the intestinal preparation by patients undergoing elective colonoscopy;
  • assessing whether the tele-consultation can reduce anxiety and procedure-related stress, promoting a better emotional state in patients undergoing colonoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE)

    Time frame: 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.

  2. H.A.D.S. (Hospital Anxiety and Depression Scale)

    Time frame: 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 outcomes

  1. Financial Toxicity (FT) using the "PROFFIT questionnaire"

    Time frame: 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).

  2. Effectiveness of a colonoscopy in detecting adenomas. Adenoma Detection Rate (ADR)

    Time frame: 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.

  3. Rate of cecal intubation

    Time frame: at the end of colonoscopy up to 12 months

    Cecal intubation rate in patients of the 2 study groups

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco De Falco, Nursing degree

CONTACT

[email protected]

0811770813 ext. 0039

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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