Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors

Wuhan University

Status: Enrolling

Conditions: Digestive System Neoplasm; Digestive System Cancer

Treatments: Other: Nutritional psychological interventions and vomit-free management

Study type: Interventional

Funder types: Other

Identifiers

NCT06223230

WDRY2022-K092

Details and patient eligibility

About

Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone

Enrollment: 316 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75, male or female;
2. Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;
3. Expected survival ³ 8 weeks and able to receive long-term follow-up;
4. Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;
5. First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group);
6. Voluntarily signing an informed consent form.

Exclusion criteria

1. Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer;
2. history of psychiatric illness prior to the diagnosis of the tumor
3. patients who resist treatment
4. patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;
5. patients who are pregnant or have a pregnancy plan;
6. patients who, in the judgment of the investigator, are not suitable for inclusion in this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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316 participants in 2 patient groups

Study group

Experimental group

Description:

First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management

Treatment:

Other: Nutritional psychological interventions and vomit-free management

Control group

No Intervention group

Description:

First-line treatment receives standard antitumor therapy