Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06223230

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

Led by Renmin Hospital of Wuhan University · Updated on 2024-01-30

316

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of nutritional psychological interventions combined with vomit-free management on survival and quality of life in patients with advanced gastrointestinal tumors. These tumors include esophageal, gastric, liver, pancreatic, and colorectal cancers. The study compares these interventions alongside standard antitumor therapy against standard therapy alone to observe differences in survival and patient well-being. Participants are randomly assigned to one of two groups. One group receives first-line standard antitumor treatment plus nutritional psychological interventions and vomit-free management, while the other group receives only the standard antitumor therapy. This double-masked study is conducted over approximately 40 months from the first participant's randomization. During the study, patients will be monitored for progression-free survival time, overall survival, quality of life, disease control rate, objective response rate, and duration of response. Researchers will track completion rates and assess these outcomes through ongoing follow-ups. The total study duration allows for long-term observation of treatment effects and patient experiences.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years, male or female
  • Diagnosed with advanced esophageal, gastric, liver, colorectal, or other gastrointestinal tumors by pathological histology or cytology
  • Expected survival of at least 8 weeks and able to receive long-term follow-up
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
  • First-line treatment receiving standard oncology treatment with or without nutritional psychological intervention and vomit-free management
  • Voluntarily signed an informed consent form
Not Eligible

You will not qualify if you...

  • Diagnosed with other malignant tumors within the previous 5 years, except effectively treated basal cell carcinoma or squamous cell carcinoma of the skin, or effectively resected in situ cervical or breast cancer
  • History of psychiatric illness prior to tumor diagnosis
  • Patients who resist treatment
  • Poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, or similar conditions
  • Pregnant or planning pregnancy
  • Judged by the investigator as not suitable for inclusion in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 40 months from date of the first participant randomization

Participants receive first-line standard antitumor therapy with or without nutritional psychological interventions and vomit-free management as part of the study.

Visits occur as part of standard oncology treatment schedule

Trial Site Locations

Total: 1 location

1

Renmin hosptial of Wuhan University

Wuhan, Hubei, China, 430060

Actively Recruiting

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Research Team

Y

Yongshun Chen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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https://pubmed.ncbi.nlm.nih.gov/20719409

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