Clinical trial NCT06092281: Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD
Official title: Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Compliance
Keywords: compliance
endoscopic submucosal dissection
surveillance
post-ESD
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: short-term endoscopic surveillance compliance
timeFrame: From enrollment to the end of the first endoscopic surveillance (3 months)
measure: Part 2: long-term endoscopic surveillance compliance
timeFrame: From enrollment to the end of the last endoscopic surveillance (1-5 years)
Secondary outcomes:
measure: Part 1: Ulcer scar rate
timeFrame: From enrollment to the end of the first endoscopic surveillance (3 months)
measure: Part 1: Correlated Factors for short-term endoscopic surveillance compliance
timeFrame: From enrollment to the end of the first endoscopic surveillance (3 months)
measure: Part 2: Incidence of metachronous lesions
timeFrame: Up to 5 years
measure: Part 2: Incidence of local recurrence
timeFrame: Up to 5 years
measure: Part 2: Overall survival rate
timeFrame: 5 years
measure: Part 2: Correlated Factors for long-term endoscopic surveillance compliance
timeFrame: From enrollment to the end of the last endoscopic surveillance (1-5 years)
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive DIsease
name: Zhiguo Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.