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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | Changes in body weight over 6 months | every month, up to half year |
| Nutritional risk and malnutrition status | Nutrition Risk Screening 2002 (NRS2002) ，the minimum value is 0 and maximum value is 7, and higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XingChen Peng, Ph.D | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan Universit | Chengdu | Sichuan | 610041 | China |
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| every month, up to half year |
| Nutritional risk and malnutrition status | Patient-Generated Subjective Global Assessment (PG-SGA)，the minimum value is 0 and maximum value is 20, and higher scores mean a worse outcome. | every month, up to half year |