Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients

Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients: a Randomized Controlled Trial

To evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer patients with radiotherapy, and process evaluation to further optimize the intervention program.

The pre-rehabilitation intervention was develped previously based on the process of evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Radiotherapy; Triple Pre-rehabilitation
• Intervention / Treatment: Other: triple pre-rehabilitation; Other: triple rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18≤ age < 75 years old
• The pathological diagnosis of HNC included nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, salivary gland cancer;
• Plan to receive radiotherapy
• Basic communication skills
• Volunteer to participate in this study.

Exclusion Criteria:

• Combined with other malignant tumors
• Distant metastasis
• Inability to measure body composition, such as metal in the body or inability to stand alone
• With contraindications to exercise (such as cardiovascular and cerebrovascular diseases, respiratory diseases, etc)
• Complicated with severe liver and kidney function damage
• Previous diagnosis of other cancers
• pregnant or lactation women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre Group; intervention before and during radiotherapy	Other: triple pre-rehabilitation; The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out from the time of enrollment (T0). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.; Other: triple rehabilitation; The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out at the time of the beginning of radiotherapy (T1), and the middle stage of radiotherapy (T2). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.
Other: Re Group; intervention during radiotherapy only	Other: triple rehabilitation; The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out at the time of the beginning of radiotherapy (T1), and the middle stage of radiotherapy (T2). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical weight loss	Weight loss over 5% during radiotherapy	About 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0	Adverse reactions of radiotherapy	About 6 weeks
Physical performance	Physical performance measured by the 4-Meter Walk Test	About 6 weeks
Physical performance	Physical performance measured by 30-Second Chair Stand Test (30-SCST)	About 6 weeks
Physical performance	Physical performance measured by hand grip strength	About 6 weeks
Body composition measured by Bioelectrical Impedance Analysis (BIA)	Body composition measured by Bioelectrical Impedance Analysis (BIA)	About 6 weeks
Quality of life of patients assessed by QLQ-C30	Quality of life of patients assessed by QLQ-C30	About 6 weeks
Intake assessed by a simple diet self-assessment tool (SDSAT)	Intake assessed by a simple diet self-assessment tool (SDSAT)	About 6 weeks
Psychological status assessed by hospital anxiety and depression scale (HADS)	Psychological status assessed by hospital anxiety and depression scale (HADS)	About 6 weeks
Number of participants with intervention-related adverse events	Number of participants with intervention-related adverse events	About 6 weeks
Patients in the intervention group were interviewed about the compliance of the study	Patients in the intervention group were interviewed about the compliance of the study	About 6 weeks
Patients in the intervention group were interviewed about the experience of the study	Patients in the intervention group were interviewed about the experience of the study	About 6 weeks

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: China International Medical Foundation
• Investigators: Study Chair: Qian Lu, Professor, School of Nursing Peking University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Pre-rehabilitation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No