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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06379191
• Other study ID #: ZS-3411
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	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	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)	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