Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer

1. transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
2. to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: cushion

Detailed Description

1. Make application-oriented achievement transformation products to provide new special semi recumbent auxiliary tools for patients with esophageal cancer after operation. Summarize the clinical experience and evidence, sign the project cooperation intention agreement with the manufacturer with production qualification, connect with the professional designer of the manufacturer and refine and improve the design scheme; The angle range, materials, fabrics and connection methods of the semi reclining cushion are closely combined with the clinical treatment and patient needs to meet the effectiveness, comfort and practicality of the patient's application; To produce semi reclining cushion products to provide semi reclining cushion for patients after esophageal cancer surgery that can be adjusted from multiple angles and take into account the skin protection function, which is conducive to preventing and alleviating reflux symptoms, improving the quality of life and reducing the risk of skin stress injury.
2. Implement and evaluate the effectiveness of the special semi reclining cushion after esophageal cancer surgery, apply the product to patients after esophageal cancer surgery, and evaluate the effect.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
2. to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer. 1. patients with pathologically confirmed esophageal cancer who underwent thoracoscopic resection and neck anastomosis;

2. age ≥ 18 years old; 3. able to read and fill in the questionnaire independently.

Exclusion criteria:

1. cognitive impairment or mental illness;
2. complicated with other serious diseases;
3. unwilling to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; In the intervention group, the special cushion for semi recumbent position was used	Device: cushion; In the intervention group, the special cushion for semi recumbent position was used
No Intervention: Group 2; Routine nursing intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux symptoms	Reflux Diagnostic Questionnaire RDQ The Reflux Diagnostic Questionnaire includes four symptoms: heartburn, acid reflux, regurgitation, and pain behind the sternum. The frequency and severity of symptoms range from 0 to 5 points. The highest score for symptom frequency and severity is 40 points. A higher score indicates more severe reflux, and a score exceeding 12 points indicates a preliminary diagnosis of gastroesophageal reflux disease	1 to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin pressure injury	The staging standard of pressure injury published by the national pressure sore Advisory Committee of the United States was applied to skin pressure injury	7 to 180 days after surgery
Postoperative quality of life QLQ-C30	European Organization for Research and Treatment of Cancer (EORTC): Quality of Life Questionnaire: EORTC QLQ-C30 The Quality of Life Questionnaire QLQ-C30 is a tool for assessing the quality of life of cancer patients, with 30 items divided into 15 domains. The scoring method is as follows: For items 29 and 30, score from 1 to 7 according to the answer options; for other items, score from 1 to 4 according to the answer options . Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain . Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 . For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .	7 days after surgery
Postoperative quality of life QLQ-OES18	European Organization for Research and Treatment of Cancer (EORTC): Esophagus-specific QOL questionnaire: EORTC QLQ-OES18 QLQ-OES18 is a module for assessing the quality of life of patients with esophageal cancer, which needs to be used together with the QLQ-C30 core questionnaire, with 18 items divided into 10 domains. The scoring method is as follows: For all items, score from 1 to 4 according to the answer options . Add up the scores of the items included in each domain and divide by the number of items included, to get the raw score of that domain . Use the range method to perform a linear transformation, converting the raw score into a standardized score between 0 and 100 . For functional domains and overall health status/quality of life domain, the higher the score, the better the functional status and quality of life; for symptom domains, the higher the score, the more symptoms or problems (the lower the quality of life) .	7 days after surgery

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: NCC2021C-266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No