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

W

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

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

Trial contacts and locations

1

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Central trial contact

Yongshun Chen, MD

Data sourced from clinicaltrials.gov

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