The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program

April 22, 2024 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

≥18 years

Pathologically confirmed ovarian cancer

Paclitaxel combined with carboplatin as a chemotherapy regimen

Normal cognitive ability and proficiency in the use of WeChat

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: usual care group
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.
Behavioral: Nutrition intervention model based on WeChat applets
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.
Experimental: Intervention group
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.
Behavioral: Nutrition intervention model based on WeChat applets
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The indicators were collected from hospital electronic medical records.
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
The indicators were collected from hospital electronic medical records.
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
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: xiaojuan Tian, chief nurse, Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZS-3411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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