Patient Satisfaction and Efficacy of Bowel-preparationNCT06887244
Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
A study testing Tele-consultation in people with Patient Satisfaction and Efficacy of Bowel-preparation and Colon Cancer Prevention, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Satisfaction and Efficacy of Bowel-preparation, Colon Cancer Prevention
- What is being tested?
- Tele-consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jun 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for outpatient pancolonoscopy:
- for diagnostic purposes;
- for screening purposes;
- for post-polypectomy follow-up;
- of both genders;
- of all ethnicities;
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
S.S.D. Garoenterologia ed Endoscopia Digestiva
Naples, 80131
Francesco De Falco, Nursing degree, 08117770813 ext. 0039, endoscopia@istitutotumori.na.it
Mario De Bellis, MD
About this study
Official title: Evaluation of the 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.
Read the 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:
- 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.
- Being tested
- Tele-consultation
- Keywords
- colonoscopy, tele-consultation procedure, colon cancer, financial toxicity, anxiety procedure-related
- Medical subject headings
- Patient Satisfaction, Colonic Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-consultationOther
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
| Study group | Role | What they receive |
|---|---|---|
| nurse tele-consultation arm | Experimental | Use of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure. Receives: Other: Tele-consultation |
| Standard arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: baseline, before colonoscopy up to 12 months
Secondary outcomes (3)
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).
Measured: baseline (before colonoscopy) up to 12 months
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.
Measured: at the end of colonoscopy up to 12 months
Rate of cecal intubation
Cecal intubation rate in patients of the 2 study groups
Measured: at the end of colonoscopy up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start24 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Satisfaction and Efficacy of Bowel-preparationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 534 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco De Falco, Nursing degree, Principal investigator, National Cancer Institute, IRCCS Fondazione G. Pascale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887244
- Sponsor's protocol ID
- Registry 26-23
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
- ClinicalTrials.gov ID
- NCT06887244
- Acronym / sponsor ID
- Registry 26-23
- Keywords
- colonoscopy, tele-consultation procedure, colon cancer, financial toxicity, anxiety procedure-related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurse tele-consultation arm | Experimental | Other: Tele-consultationUse of the nurse tele-consultation tool in the Intervention arm administered 5±2 days before the colonoscopy procedure. |
| Standard arm | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- for diagnostic purposes;
- for screening purposes;
- for post-polypectomy follow-up;
- of both genders;
- of all ethnicities;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-consultationTele-consultation procedure is defined as a telephone consultation with the patient conducted by nursing staff with an appropriate level of experience in digestive endoscopy | Other | nurse tele-consultation arm |
Primary outcome
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.
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco De Falco, Nursing degree principal investigator
National Cancer Institute, IRCCS Fondazione G. Pascale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-consultation in people with Patient Satisfaction and Efficacy of Bowel-preparation and Colon Cancer Prevention, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco De Falco, Nursing degree (0811770813 ext. 0039, endoscopia@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of intestinal preparation. BBPS score (BOSTON BOWEL PREPARATION SCORE) (time frame: at the end of colonoscopy up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.