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

NCT06092281 | Recruiting DMC

• 1 other identifier: KY20232292-F-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Compliance

Keywords

compliance; endoscopic submucosal dissection; surveillance; post-ESD

Outcome Measures

Primary Outcomes (2)

• Part 1: short-term endoscopic surveillance compliance

  Patients who undergo their first endoscopic surveillance within 3 months after ESD are considered to have good compliance, otherwise they are considered to have poor compliance.

  From enrollment to the end of the first endoscopic surveillance (3 months)

• Part 2: long-term endoscopic surveillance compliance

  The criteria for endoscopic surveillance after ESD in this study are as follows: (1) For patients with non-neoplastic lesions and benign tumors after ESD, a follow-up of at least 1 year is required; (2) For patients with low-grade intraepithelial neoplasia and adenoma after ESD, a follow-up of at least 1 year is required; (3) For patients with high-grade intraepithelial neoplasia, a follow-up of at least 3 years is required, with an interval not exceeding 2 years; (4) For patients with carcinoma, a follow-up of at least 5 years is required, with an interval not exceeding 2 years. The criteria for assessing the compliance of endoscopic surveillance in this study are as follows: Patients who undergo endoscopic surveillance according to the above-mentioned criteria are considered to have good compliance, otherwise they are considered to have poor compliance.

  From enrollment to the end of the last endoscopic surveillance (1-5 years)

Secondary Outcomes (6)

• Part 1: Ulcer scar rate

  From enrollment to the end of the first endoscopic surveillance (3 months)

• Part 1: Correlated Factors for short-term endoscopic surveillance compliance

  From enrollment to the end of the first endoscopic surveillance (3 months)

• Part 2: Incidence of metachronous lesions

  Up to 5 years

• Part 2: Incidence of local recurrence

  Up to 5 years

• Part 2: Overall survival rate

  5 years

Study Arms (2)

Control Arm

EXPERIMENTAL

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.

Behavioral: Questionnaire without compliance-related education

Questionnaire Arm

EXPERIMENTAL

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.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Patients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information: 1. General information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.) 2. Awareness of follow-up examinations (e.g., knowledge about the timing of the first follow-up, the process of follow-up examinations, related educational issues about follow-up, etc.) 3. Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)

Questionnaire Arm

Questionnaire without compliance-related education BEHAVIORAL

Patients after ESD need to complete a questionnaire without compliance-related education before discharge. The questionnaire includes only general information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (4)

• Ono H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, Iishi H, Oka M, Ajioka Y, Fujimoto K. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition). Dig Endosc. 2021 Jan;33(1):4-20. doi: 10.1111/den.13883. Epub 2020 Dec 9.

  PMID: 33107115 BACKGROUND

• Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Saitoh Y, Tsuruta O, Sugihara KI, Igarashi M, Toyonaga T, Ajioka Y, Kusunoki M, Koike K, Fujimoto K, Tajiri H. Japan Gastroenterological Endoscopy Society guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2020 Jan;32(2):219-239. doi: 10.1111/den.13545. Epub 2019 Dec 27.

  PMID: 31566804 BACKGROUND

• Ishihara R, Arima M, Iizuka T, Oyama T, Katada C, Kato M, Goda K, Goto O, Tanaka K, Yano T, Yoshinaga S, Muto M, Kawakubo H, Fujishiro M, Yoshida M, Fujimoto K, Tajiri H, Inoue H; Japan Gastroenterological Endoscopy Society Guidelines Committee of ESD/EMR for Esophageal Cancer. Endoscopic submucosal dissection/endoscopic mucosal resection guidelines for esophageal cancer. Dig Endosc. 2020 May;32(4):452-493. doi: 10.1111/den.13654.

  PMID: 32072683 BACKGROUND

• Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6.

  PMID: 35523224 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zhiguo Liu

  Xijing Hospital of Digestive DIsease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguo Liu

CONTACT

86-29-84771535; liuzhiguo@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)