Collaborative Tele-Nutritional Care for Patient With Stage IV Cancer

NCT06332664 | Completed

• 1 other identifier: 2023-2330
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Keywords

cancer cachexia

Outcome Measures

Primary Outcomes (1)

• the incidence of cachexia

  The definition and classification of cancer cachexia was used by an international consensus \[9, 10\]: (1) weight loss \> 5% over the past 6 months (in the absence of simple starvation), (2) BMI \< 20 and any degree of weight loss \> 2%, or (3) appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss \> 2%. The assessment of skeletal muscle depletion was used by mid-upper arm muscle area by anthropometry (men \< 32 cm2, women \< 18 cm2)

  every month, up to half year

Secondary Outcomes (3)

• body weight

  every month, up to half year

• Nutritional risk and malnutrition status

  every month, up to half year

• Nutritional risk and malnutrition status

  every month, up to half year

Study Arms (2)

Early Nutrition Intervention

EXPERIMENTAL

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.

Combination Product: Early Nutrition Intervention

standard care

NO INTERVENTION

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.

Interventions

Early Nutrition Intervention 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.

Early Nutrition Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients should be at the range of 18-80 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
• The patients should be diagnosed, untreated stage IV cancer patients requiring chemotherapy;
• The patients should have good cognitive and reading abilities to complete questionnaires;
• The patients should have ≥3 months expected survival period

You may not qualify if:

• Patients with neurological or psychiatric disorders affecting cognitive function, including central nervous system metastases from tumors;
• Patients with severe diseases affecting digestion, metabolism, or food intake;
• Presence of contraindications to chemotherapy;
• Patients in a cachectic state or refractory cachexia;
• Patients with PG-SGA score ≥9 points

Sponsors & Collaborators

• Xingchen Peng: lead

Study Sites (1)

West China Hospital, Sichuan Universit

Chengdu, Sichuan, 610041, China

Location

Study Officials

• XingChen Peng, Ph.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 27, 2024
• Study Start: March 28, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (1)