Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors

Samsung Medical Center

Status: Enrolling

Conditions: Esophageal Cancer

Treatments: Dietary Supplement: Ecological nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07024849

RS-2023-CC139778 (Other Grant/Funding Number)

2023-05-127

Details and patient eligibility

About

This study aims to apply and assess the clinical feasibility of a health behavior theory-based ecological nutrition intervention program, providing nutrition care tailored to the unmet needs of esophageal cancer survivors after surgery.

Esophageal cancer survivors will receive a 4-week nutrition intervention program tailored to their individual nutritional needs. The program includes providing nutritional guidelines, customized care food, encouraging walking through a wearable device, and weekly telephone counseling. The evaluation of the program will assess food intake, adherence to dietary guidelines, activity level, nutritional indicators (such as PNI and NRI), weight change, fatigue, symptoms, quality of life, and satisfaction with meals and services. Additionally, interviews will be conducted after the intervention to evaluate the patient's experience.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical stage 1-3 primary esophageal cancer at diagnosis who have planned or received treatment, including esophageal resection and reconstruction, with curative intent, and their families*.
• You are at least 18 years of age
• Have a native-level understanding of Korean
• Who consented to this study

Exclusion criteria

• Concurrent multiple cancers at the time of diagnosis or a history of diagnosed and treated other organ cancers within the past year at the time of diagnosis
• Have had esophageal resection and reconstruction surgery for other reasons before being diagnosed with esophageal cancer
• Persons with limited cognitive and communication abilities
• The patient has had problems progressing to oral feeding after surgery, requiring a concurrent ileostomy, or the investigator determines that an interventional study is not appropriate.
• Individuals with reduced renal function for whom protein intake is not recommended (estimated GFR <60 mL/min/1.73 m2)
• People who are unable to walk due to joint problems, paralysis, etc.
• Those who do not use smartphones

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Nutrition Intervention group

Experimental group

Description:

This is a single-arm study, with all participants in the intervention arm. Patients in the intervention arm will receive a 4-week nutrition management program.

Treatment:

Dietary Supplement: Ecological nutritional intervention