Nutrition Education Program for Cancer Patients Receiving Radiotherapy

NCT05329688 | Unknown DMC

• 1 other identifier: IRB110-196-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

Conditions

Radiotherapy Side Effect; Nutrition Related Cancer

Keywords

nutrition; radiotherapy; cancer patients

Outcome Measures

Primary Outcomes (4)

• risk of malnutrition

  Nutrition Risk Screening 2002 is used to assess the risk of malnutrition.

  Week 0, 12

• BMI

  Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square.

  Week 0, 12

• albumin

  level of serum albumin

  Week 0, 12

• Quality of Life (QOL)

  The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom.

  Week 0, 12

Secondary Outcomes (2)

• physical function status

  Week 0, 12

• Knowledge-Attitude-Practice

  Week 0, 12

Study Arms (2)

Arm A

EXPERIMENTAL

Novel nutrition program : Give nutrition health education every week and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.

Procedure: novel nutrition program

Arm B

ACTIVE COMPARATOR

Routine nutrition education Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.

Procedure: novel nutrition program

Interventions

novel nutrition program PROCEDURE

Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.

Arm A; Arm B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer.
• Patients need nutrition support treatment
• Informed consent

You may not qualify if:

• Critical patients or life expectancy \< 12 weeks
• Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke.
• Unconscious or psychiatric patients
• Patients with communication problems

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead
• Asia University: collaborator

Study Sites (1)

Szu-Yuan Wu

Taipei, Please Select, 116, Taiwan

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Szu-Yuan Wu

  Asia University, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Szu-Yuan Wu

CONTACT

+886910603955; szuyuanwu5399@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind (Participant)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single blind (Participant)

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will become available on June 30 2022.
• Access Criteria: requirement with official application

Locations

TW (1)