Gastric CancerNCT03952442
Nutrition Education Program for Postoperative Patients With Gastric Cancer
A study testing standardized nutrition education and routine nutrition education in people with Gastric Cancer and Nutrition Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Using randomized control study, explore the effect of standardized nutrition education program on the nutrition status and life quality of patients with gastric cancer after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Nutrition Disorders
- What is being tested?
- standardized nutrition education and routine nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2019to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are diagnosed with gastric cancer and receive operation.
- Patients need nutrition support treatment
- Informed consent.
Who cannot join
- Critical patients or stage IV
- Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
- Unconscious or psychiatric patients
- Patients with communication problems
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31009
Haiyan Zhou, Bachelor, 13857160575, 731061631@qq.com
About this study
Official title: The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
Using randomized control study, explore the effect of standardized nutrition education program on the nutrition status and life quality of patients with gastric cancer after surgery.
- Conditions
- Gastric Cancer, Nutrition Disorders
- Being tested
- standardized nutrition education, routine nutrition education
- Keywords
- gastric cancer, nutrition, health education
- Medical subject headings
- Stomach Neoplasms, Nutrition Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized nutrition educationOther
Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.
routine nutrition educationOther
Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Other: routine nutrition education |
| experimental group | Experimental | Not described Receives: Other: standardized nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of malnutrition
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
Measured: Week 0
risk of malnutrition
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
Measured: Week 12
BMI
Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.
Measured: Week 0
BMI
Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.
Measured: Week 12
albumin
level of serum albumin
Measured: Week 0
albumin
level of serum albumin
Measured: Week 12
Quality of Life (QOL)
The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.
Measured: Week 0
Quality of Life (QOL)
The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.
Measured: Week 12
Secondary outcomes (3)
physical function status
Using Eastern Cooperative Oncology Group to assess the physical function.
Measured: Week 0
physical function status
Using Eastern Cooperative Oncology Group to assess the physical function.
Measured: Week 12
Knowledge-Attitude-Practice
Knowledge Scale composes of 10 questions and 10 scores for each question. Attitude and Practice Scale have 5 questions. Each question is rated as A、B、C. A represents 20 score and B is 10 score.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start21 Feb 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952442
- Sponsor's protocol ID
- 2018-211
- Status last verified
- May 2019
- First submitted
- 5 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Postoperative Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT03952442
- Acronym / sponsor ID
- 2018-211
- Conditions
- Gastric Cancer, Nutrition Disorders
- Keywords
- gastric cancer, nutrition, health education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 May 2019 (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.
Using randomized control study, explore the effect of standardized nutrition education program on the nutrition status and life quality of patients with gastric cancer after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: routine nutrition education |
| experimental group | Experimental | Other: standardized nutrition education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are diagnosed with gastric cancer and receive operation.
- Patients need nutrition support treatment
- Informed consent.
Key exclusion criteria (4 listed)
- Critical patients or stage IV
- Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
- Unconscious or psychiatric patients
- Patients with communication problems
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 |
|---|---|---|
| standardized nutrition educationGive nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease. | Other | experimental group |
| routine nutrition educationGive nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients. | Other | control group |
Primary outcome
risk of malnutrition
Time frame: Week 0
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
risk of malnutrition
Time frame: Week 12
Nutrition Rsik Screening 2002 is used to assess the risk of malnutrition.
BMI
Time frame: Week 0
Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.
BMI
Time frame: Week 12
Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.
albumin
Time frame: Week 0
level of serum albumin
albumin
Time frame: Week 12
level of serum albumin
Quality of Life (QOL)
Time frame: Week 0
The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.
Quality of Life (QOL)
Time frame: Week 12
The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.
3 secondary outcomes
physical function status
Time frame: Week 0
physical function status
Time frame: Week 12
Knowledge-Attitude-Practice
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: No
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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.
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized nutrition education and routine nutrition education in people with Gastric Cancer and Nutrition Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 21 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of malnutrition (time frame: Week 0). The study lists 8 primary outcomes in all. 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 21 May 2019.