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

NCT07024849 | Recruiting

• 2 other identifiers: 2023-05-127RS-2023-CC139778
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer

Keywords

nutritional intervention; nutrition; survivors; esophageal cancer; care foods; health behavior; ecological intervention

Outcome Measures

Primary Outcomes (1)

• Survey Questionnaire on Health Behavior Change through an Intervention Program

  Adherence to nutritional guidelines including food intake

  Baseline, end of intervention (post-enrollment 4 weeks)

Secondary Outcomes (11)

• Change in body weight (kg)

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in body composition (fat mass and fat-free mass)

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in Body Mass Index (BMI) (kg/m²)

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) score

  Baseline, end of intervention (post-enrollment 4 weeks)

Other Outcomes (11)

• Change in grip strength (kg)

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in serum albumin (g/dL)

  Baseline, end of intervention (post-enrollment 4 weeks)

• Change in prealbumin (mg/dL)

  Baseline, end of intervention (post-enrollment 4 weeks)

Study Arms (1)

Nutrition Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Ecological nutritional intervention

Interventions

Ecological nutritional intervention DIETARY_SUPPLEMENT

Patients in the intervention arm will receive a 4-week nutrition management program(1 week for patients more than 4 months post-surgery), which includes providing nutritional guidelines, home delivery of personalized care foods, encouragement of physical activity using a wearable device, and weekly phone calls to check on nutritional goals and symptoms. Management services are also available through the mobile application.

Nutrition Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Health Behavior

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Behavior

Study Officials

• Juhee Cho, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juhee Cho, PhD

CONTACT

+8234101448; alfadur2j@gmail.com

genehee lee, PhD

CONTACT

+82 3410 1062; genehee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Education Center

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 17, 2025
• Study Start: April 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)