Ovarian CancerNCT06379191
The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program
A study testing Nutrition intervention model based on WeChat applets in people with Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Nutrition intervention model based on WeChat applets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years
- Pathologically confirmed ovarian cancer
- Paclitaxel combined with carboplatin as a chemotherapy regimen
- Normal cognitive ability and proficiency in the use of WeChat
Who cannot join
- Malignant tumor of another system
- Serious illness or failure of vital organs such as the heart, lungs, liver and kidneys
- Receiving enteral or parenteral nutritional support
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program on the Nutritional Status of Ovarian Cancer Patients Undergoing Chemotherapy: a Randomized Controlled Trial
As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted.
Read the detailed description
Ovarian cancer (OC) is the most malignant type of tumor in the female reproductive system with poor prognosis. According to the latest statistics, there are 196,000 estimated OC cases, 45,000 estimated new cases, and 29,000 estimated OC deaths in China, making this disease become the second leading cause of death among Chinese women.
Approximately 90% of patients with OC receive chemotherapy. The carboplatin-paclitaxel combination as a first-line chemotherapy regimen for OC has shown considerable efficacy over the past 30 years. Unfortunately, one of the major adverse effects of chemotherapy is malnutrition. Malnutrition is defined as a nutritional condition in which deficiencies of energy, protein and other nutrients have measurable adverse effects on tissue/body form, function and clinical outcomes. The most common adverse effects of chemotherapy, including anorexia, altered taste and smell, food aversions, nausea and vomiting, mucositis, xerostomia, constipation, diarrhea and early satiety, negatively affect nutritional status. Malnutrition has been shown to be one of the leading causes of death in OC patients. It not only severely diminishes the efficacy of treatment, but leads to increased complications, decreased quality of life, prolonged hospitalization, increased healthcare costs, and shorter survival time. However, existing nutritional interventions lack personalized guidance for patients' nutritional status and symptoms during chemotherapy. In addition, it is difficult to centrally manage patients who are homebound between chemotherapy. Therefore, the construction of personalized nutritional management programs and the development of innovative telemedicine interventions for OC patients undergoing chemotherapy has become an urgent issue.
WeChat, a very popular social application in China, has more than 1 billion monthly active users. It is easy to operate and offers multiple functions such as text and voice messaging, free voice and video calls, group chats, subscription to public accounts and applets, etc. WeChat has been demonstrated to be an effective and more cost-efficient technological tool for chronic disease management. Currently, the application of WeChat in cancer patients mainly focuses on discharge follow-up, symptom management, cancer prevention, and intervention of psychological problems. The effect of WeChat application in nutritional management of cancer patients has not been explored. Therefore, the aim of this study was to implement a continuous follow-up strategy and health monitoring based on a WeChat platform for OC patients undergoing chemotherapy during the chemotherapy interval to ensure that each phase of chemotherapy is delivered on schedule and to improve the survival rate of cancer patients.
- Conditions
- Ovarian Cancer
- Being tested
- Nutrition intervention model based on WeChat applets
- Keywords
- WeChat, nutrition management, ovarian cancer, chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition intervention model based on WeChat appletsBehavioural
We recorded the full nutritional management plan for ovarian cancer chemotherapy patients obtained through evidence-based in the previous period into the applet developed by our team - "Good Nutrition". At the first chemotherapy admission assessment, patients were instructed to search for the applet on WeChat and add it to "My applet". The patient was introduced to the main functional sections of the applet and the content settings for each section. The patient was instructed to turn on the applet notification permission and set it to receive new content alerts. Patients were invited to join our nutrition management group chat. They were informed that throughout the intervention phase, we would be sending evidence-based scientific articles to the group chat for independent study, and that they were allowed to ask questions, share personal experiences, and discuss lifestyles within the group.
| Study group | Role | What they receive |
|---|---|---|
| usual care group | Placebo comparator | Upon admission, patients were provided with admission counselling, explained the complications associated with chemotherapy, and given a chemotherapy care booklet and a leaflet on diet and nutrition. Before discharge, the patients were given the nutritional guidebook again. Responsible nurses made one telephone follow-up visit between chemotherapy sessions. Receives: Behavioral: Nutrition intervention model based on WeChat applets |
| Intervention group | Experimental | Patients were instructed to search for the "Good Nutrition" applet on WeChat and added it to their "My Applets" for easy access. The patient was informed of the users' nameand password. The patient was introduced to the main functional sections of the applet and the content settings of each section to become familiar with the applet. Patients were invited to join our nutrition management group chat. At the same time, patients were allowed to choose to have a private chat with a member of the nutrition management team via WeChat at any time. Receives: Behavioral: Nutrition intervention model based on WeChat applets |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-generated subjective global assessment (PG-SGA)
PG-SGA was used as a prognostic tool developed specifically for patients with cancer to evaluate the nutritional status. It consisted of two subscales, the patient self-assessment scale and the medical staff assessment scale. The former integrated short-term weight loss, food intake (including amount eaten, type of food, manner of eating, etc.), symptoms affecting eating, activity and physical functioning, and nutritional difficulties and activities. The latter included medical history, metabolic stress and physical examination provided by medical staff. Each item in the PG-SGA scale has a score range of 0-4. The more severe the symptoms in relation to malnutrition the higher the assigned value.
Measured: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
Secondary outcomes (3)
nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L)
The indicators were collected from hospital electronic medical records.
Measured: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L)
The indicators were collected from hospital electronic medical records.
Measured: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII)
PNI is calculated as "albumin (g/L) + 5 × lymphocyte (10^9/L). SII is calculated as "platelet(10^9/L)×neutrophil (10^9/L)]/lymphocyte (10^9/L)
Measured: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Feb 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojuan Tian, chief nurse, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379191
- Sponsor's protocol ID
- ZS-3411
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tian X, Liu Y, Zhang J, Yang L, Feng L, Qi A, Liu H, Liu P, Li Y. Efficacy of a WeChat-Based, Multidisciplinary, Full-Course Nutritional Management Program on the Nutritional Status of Patients With Ovarian Cancer Undergoing Chemotherapy: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Nov 4;12:e56475. doi: 10.2196/56475.
PubMed 39496160
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program on the Nutritional Status of Ovarian Cancer Patients Undergoing Chemotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06379191
- Acronym / sponsor ID
- ZS-3411
- Conditions
- Ovarian Cancer
- Keywords
- WeChat, nutrition management, ovarian cancer, chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 23 Apr 2024 (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.
As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted.
Detailed description
Ovarian cancer (OC) is the most malignant type of tumor in the female reproductive system with poor prognosis. According to the latest statistics, there are 196,000 estimated OC cases, 45,000 estimated new cases, and 29,000 estimated OC deaths in China, making this disease become the second leading cause of death among Chinese women.
Approximately 90% of patients with OC receive chemotherapy. The carboplatin-paclitaxel combination as a first-line chemotherapy regimen for OC has shown considerable efficacy over the past 30 years. Unfortunately, one of the major adverse effects of chemotherapy is malnutrition. Malnutrition is defined as a nutritional condition in which deficiencies of energy, protein and other nutrients have measurable adverse effects on tissue/body form, function and clinical outcomes. The most common adverse effects of chemotherapy, including anorexia, altered taste and smell, food aversions, nausea and vomiting, mucositis, xerostomia, constipation, diarrhea and early satiety, negatively affect nutritional status. Malnutrition has been shown to be one of the leading causes of death in OC patients. It not only severely diminishes the efficacy of treatment, but leads to increased complications, decreased quality of life, prolonged hospitalization, increased healthcare costs, and shorter survival time. However, existing nutritional interventions lack personalized guidance for patients' nutritional status and symptoms during chemotherapy. In addition, it is difficult to centrally manage patients who are homebound between chemotherapy. Therefore, the construction of personalized nutritional management programs and the development of innovative telemedicine interventions for OC patients undergoing chemotherapy has become an urgent issue.
WeChat, a very popular social application in China, has more than 1 billion monthly active users. It is easy to operate and offers multiple functions such as text and voice messaging, free voice and video calls, group chats, subscription to public accounts and applets, etc. WeChat has been demonstrated to be an effective and more cost-efficient technological tool for chronic disease management. Currently, the application of WeChat in cancer patients mainly focuses on discharge follow-up, symptom management, cancer prevention, and intervention of psychological problems. The effect of WeChat application in nutritional management of cancer patients has not been explored. Therefore, the aim of this study was to implement a continuous follow-up strategy and health monitoring based on a WeChat platform for OC patients undergoing chemotherapy during the chemotherapy interval to ensure that each phase of chemotherapy is delivered on schedule and to improve the survival rate of cancer patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care group | Placebo comparator | Behavioral: Nutrition intervention model based on WeChat appletsUpon admission, patients were provided with admission counselling, explained the complications associated with chemotherapy, and given a chemotherapy care booklet and a leaflet on diet and nutrition. Before discharge, the patients were given the nutritional guidebook again. Responsible nurses made one telephone follow-up visit between chemotherapy sessions. |
| Intervention group | Experimental | Behavioral: Nutrition intervention model based on WeChat appletsPatients were instructed to search for the "Good Nutrition" applet on WeChat and added it to their "My Applets" for easy access. The patient was informed of the users' nameand password. The patient was introduced to the main functional sections of the applet and the content settings of each section to become familiar with the applet. Patients were invited to join our nutrition management group chat. At the same time, patients were allowed to choose to have a private chat with a member of the nutrition management team via WeChat at any time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- Pathologically confirmed ovarian cancer
- Paclitaxel combined with carboplatin as a chemotherapy regimen
- Normal cognitive ability and proficiency in the use of WeChat
Key exclusion criteria (3 listed)
- Malignant tumor of another system
- Serious illness or failure of vital organs such as the heart, lungs, liver and kidneys
- Receiving enteral or parenteral nutritional support
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 |
|---|---|---|
| Nutrition intervention model based on WeChat appletsWe recorded the full nutritional management plan for ovarian cancer chemotherapy patients obtained through evidence-based in the previous period into the applet developed by our team - "Good Nutrition". At the first chemotherapy admission assessment, patients were instructed to search for the applet on WeChat and add it to "My applet". The patient was introduced to the main functional sections of the applet and the content settings for each section. The patient was instructed to turn on the applet notification permission and set it to receive new content alerts. Patients were invited to join our nutrition management group chat. They were informed that throughout the intervention phase, we would be sending evidence-based scientific articles to the group chat for independent study, and that they were allowed to ask questions, share personal experiences, and discuss lifestyles within the group. | Behavioural | Intervention group, usual care group |
Primary outcome
patient-generated subjective global assessment (PG-SGA)
Time frame: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
PG-SGA was used as a prognostic tool developed specifically for patients with cancer to evaluate the nutritional status. It consisted of two subscales, the patient self-assessment scale and the medical staff assessment scale. The former integrated short-term weight loss, food intake (including amount eaten, type of food, manner of eating, etc.), symptoms affecting eating, activity and physical functioning, and nutritional difficulties and activities. The latter included medical history, metabolic stress and physical examination provided by medical staff. Each item in the PG-SGA scale has a score range of 0-4. The more severe the symptoms in relation to malnutrition the higher the assigned value.
3 secondary outcomes
nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L)
Time frame: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L)
Time frame: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII)
Time frame: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy
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 23 Apr 2024.
- Derived from this study: PubMed 39496160Tian X, Liu Y, Zhang J, Yang L, Feng L, Qi A, Liu H, Liu P, Li Y. Efficacy of a WeChat-Based, Multidisciplinary, Full-Course Nutritional Management Program on the Nutritional Status of Patients With Ovarian Cancer Undergoing Chemotherapy: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Nov 4;12:e56475. doi: 10.2196/56475.
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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.
xiaojuan Tian, chief nurse principal investigator
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition intervention model based on WeChat applets in people with Ovarian Cancer, run by Peking Union Medical College Hospital 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 4 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 23 Apr 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. Some participants in this study may receive a placebo. 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?
patient-generated subjective global assessment (PG-SGA) (time frame: T0=before the first admission to the hospital for chemotherapy, T1=2 weeks after the first chemotherapy, and T6=2 weeks after the sixth chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379191, which also lists 1 linked publication.
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 23 Apr 2024.