Collaborative Tele-Nutritional Care for Patient With Stage IV Cancer (T-NICE)

Xingchen Peng

Status: Completed

Conditions: Nutrition

Treatments: Combination Product: Early Nutrition Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06332664

2023-2330

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Early Nutrition Intervention

Experimental group

Description:

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.

Treatment:

Combination Product: Early Nutrition Intervention

standard care

No Intervention group

Description:

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.