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

NCT06379191 | Completed

• 1 other identifier: ZS-3411
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

WeChat; nutrition management; ovarian cancer; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/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

• inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (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

• nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII)

  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

Study Arms (2)

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.

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.

Behavioral: Nutrition intervention model based on WeChat applets

Interventions

Nutrition intervention model based on WeChat applets BEHAVIORAL

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.

Intervention group; usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• Pathologically confirmed ovarian cancer
• Paclitaxel combined with carboplatin as a chemotherapy regimen
• Normal cognitive ability and proficiency in the use of WeChat

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• xiaojuan Tian, chief nurse

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: April 23, 2024
• Study Start: February 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-02

Locations

CN (1)