Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD

Xijing Hospital of Digestive Diseases

Status: Enrolling

Conditions: Patient Compliance

Treatments: Behavioral: Questionnaire; Behavioral: Questionnaire without compliance-related education

Study type: Interventional

Funder types: Other

Identifiers

NCT06092281

KY20232292-F-1

Details and patient eligibility

About

Endoscopic submucosal dissection (ESD) is now considered the standard treatment for early gastrointestinal neoplasms. However, there is still a possibility of developing local recurrence or metachronous neoplasia after ESD. Regular endoscopic surveillance after ESD can identify and remove local recurrences and metachronous lesions early, improving patient prognosis. However, the patient compliance with post-ESD endoscopic surveillance is currently unclear, and many patients fail to adhere to the scheduled follow-up. A prospective, randomized controlled, superiority trial was designed to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.

This study will consist of two parts.

Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance.

Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance.

Full description

This is a prospective, randomized controlled, superiority trial. The study population consists of patients after ESD for mucosal lesions at Xijing Hospital. In the control arm, patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education. In the questionnaire arm, in addition to receiving the same follow-up instructions as the control arm, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance. Patients and doctors will be blind to the group of patients during the trial process. Our objective is to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.

Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance. Part 1 will be expected to include 220 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Sample size calculation is based on short-term compliance data from a pilot trial, with a 20% difference between the two groups. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a superiority margin of 5%, a sample size of 220 cases is required.

Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance. Part 2 will be expected to include 500 post-ESD patients randomized 1:1 into the questionnaire arm and control arm. Under the conditions of an α error of 5% (in a one-sided test) and power of 80%, assuming a 20% difference between the two groups in long-term compliance outcome, a superiority margin of 10%, and rounding up, a sample size of 500 cases is required.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥18 years) after ESD for mucosal lesions.

Exclusion criteria

• Patients after ESD for submucosal tumors, e.g. stromal tumors, neuroendocrine tumors;
• Additional radical surgery after ESD procedure;
• Past history of ESD procedure or local recurrence;
• Severe comorbidities with a life expectancy of <6 months as judged by the investigator;
• Unable to cooperate with information collection due to mental disorders, severe neurosis, or dysgnosia;
• Unable to understand or unwilling to sign a written informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Control Arm

Experimental group

Description:

Patients after ESD are informed on follow-up instructions by doctors about the follow-up requirements before discharge, and complete a questionnaire without compliance-related education.

Treatment:

Behavioral: Questionnaire without compliance-related education

Questionnaire Arm

Experimental group

Description:

In addition to receiving the same follow-up instructions as the control group, patients need to complete a questionnaire on compliance-related education before discharge. Based on the responses, nurses provide feedback and guidance.

Treatment:

Behavioral: Questionnaire