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

Study Overview
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Brief Summary
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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.

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

Conditions
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Triple Pre-rehabilitation, Radiotherapy, Head and Neck Cancer

Intervention / Treatment
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* Other: triple pre-rehabilitation
* Other: triple rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre Group<br>intervention before and during radiotherapy | Other: triple pre-rehabilitation<br>* 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.<br>Other: triple rehabilitation<br>* 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.<br>|
| Other: Re Group<br>intervention during radiotherapy only | Other: triple rehabilitation<br>* 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.<br>|

What is the study measuring?
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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 |