Collaborative Tele-Nutritional Care for Patient With Stage IV Cancer

NCT ID: NCT06332664

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-08-30

Brief Summary

In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.

However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.

Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting stage IV cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice.

Conditions

Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Early Nutrition Intervention

For patients meeting the inclusion criteria and randomly assigned to the intervention group, the investigators will assess their nutritional status monthly. During the home-based period between chemotherapy cycles, the investigators will conduct follow-up and provide care using a mobile application (APP). In the event of new nutritional risks emerging in patients, timely recommendations for medical consultation will be made, and nutritional plans will be formulated accordingly.

Group Type: EXPERIMENTAL

Early Nutrition Intervention

Intervention Type: COMBINATION_PRODUCT

This involves a multidisciplinary team intervention, including oncologists, nutritionists, and nurses. Additionally, the intervention introduces a team-developed mobile application (APP) for the purpose of regular patient follow-ups to identify nutritional risks promptly and facilitate timely interventions. Patients identified as at risk through the app follow-up will be referred to the nutrition clinic for consultation to address nutritional concerns. For advanced-stage cancer patients undergoing monthly chemotherapy hospitalizations, comprehensive assessments encompassing nutrition, psychological aspects, and other facets will be conducted during hospital stays. When deemed necessary, patients will receive dietary guidance and nutritional support.

standard care

Patients randomly assigned to the standard treatment group will receive standard care for cancer patients and will not be scheduled for interdisciplinary supportive therapy assessment unless requested by the patient, the primary oncologist, or their family.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early Nutrition Intervention

This involves a multidisciplinary team intervention, including oncologists, nutritionists, and nurses. Additionally, the intervention introduces a team-developed mobile application (APP) for the purpose of regular patient follow-ups to identify nutritional risks promptly and facilitate timely interventions. Patients identified as at risk through the app follow-up will be referred to the nutrition clinic for consultation to address nutritional concerns. For advanced-stage cancer patients undergoing monthly chemotherapy hospitalizations, comprehensive assessments encompassing nutrition, psychological aspects, and other facets will be conducted during hospital stays. When deemed necessary, patients will receive dietary guidance and nutritional support.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.

2. The patients should be diagnosed, untreated stage IV cancer patients requiring chemotherapy;

3. The patients should have good cognitive and reading abilities to complete questionnaires;

4. The patients should have ≥3 months expected survival period

Exclusion Criteria

1. Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;

2. Patients with severe diseases affecting digestion, metabolism, or food intake;

3. Presence of contraindications to chemotherapy;

4. Patients in a cachectic state or refractory cachexia;

5. Patients with PG-SGA score ≥9 points

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xingchen Peng

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

PhD, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

XingChen Peng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan Universit

Chengdu, Sichuan, China

Countries

China

Other Identifiers

2023-2330

Identifier Type: -

Identifier Source: org_study_id