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

NCT ID: NCT07024849

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nutrition Intervention group

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.

Group Type EXPERIMENTAL

Ecological nutritional intervention

Intervention Type 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.

Interventions

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Ecological nutritional intervention

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Juhee Cho

Director of Cancer Education Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juhee Cho, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Juhee Cho, PhD

Role: CONTACT

+8234101448

genehee lee, PhD

Role: CONTACT

+82 3410 1062

Facility Contacts

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Juhee Cho, PhD

Role: primary

+8234101448

Genehee Lee, PhD

Role: backup

+8234101062

Other Identifiers

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RS-2023-CC139778

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-05-127

Identifier Type: -

Identifier Source: org_study_id

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