Esophageal CancerNCT05542680
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
A study testing cushion in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- cushion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- 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.
Who cannot join
- cognitive impairment or mental illness;
- complicated with other serious diseases;
- unwilling to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
Read the detailed description
- 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.
- 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.
- Conditions
- Esophageal Cancer
- Being tested
- cushion
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cushionDevice
In the intervention group, the special cushion for semi recumbent position was used
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | In the intervention group, the special cushion for semi recumbent position was used Receives: Device: cushion |
| Group 2 | No intervention | Routine nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 to 30 days after surgery
Secondary outcomes (3)
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) .
Measured: 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) .
Measured: 7 days after surgery
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
Measured: 7 to 180 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start30 Sep 2022
- Primary completion1 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542680
- Sponsor's protocol ID
- NCC2021C-266
- Status last verified
- Jun 2024
- First submitted
- 28 Aug 2022
- Last updated
- 27 Jun 2024
- Results posted
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05542680
- Acronym / sponsor ID
- NCC2021C-266
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Sep 2022 (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.
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- to verify the effect of using special semi recumbent cushion for postoperative patients with esophageal cancer.
Detailed description
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: cushionIn the intervention group, the special cushion for semi recumbent position was used |
| Group 2 | No intervention | –Routine nursing intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- transform and produce the authorized utility model invention patent "a special cushion for semi recumbent position".
- 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.
Key exclusion criteria (3 listed)
- cognitive impairment or mental illness;
- complicated with other serious diseases;
- unwilling to participate in this study.
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 |
|---|---|---|
| cushionIn the intervention group, the special cushion for semi recumbent position was used | Device | Group 1 |
Primary outcome
Reflux symptoms
Time frame: 1 to 30 days after surgery
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
3 secondary outcomes
Postoperative quality of life QLQ-C30
Time frame: 7 days after surgery
Postoperative quality of life QLQ-OES18
Time frame: 7 days after surgery
Skin pressure injury
Time frame: 7 to 180 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cushion in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jun 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux symptoms (time frame: 1 to 30 days after surgery). 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 27 Jun 2024.