Clinical trial NCT06379191: The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: WeChat
nutrition management
ovarian cancer
chemotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient-generated subjective global assessment (PG-SGA)
timeFrame: 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:
measure: nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L)
timeFrame: 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
measure: inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L)
timeFrame: 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
measure: nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College
name: xiaojuan Tian, chief nurse
role: PRINCIPAL_INVESTIGATOR
References: