Head and Neck Cancer, Radiotherapy, Triple Pre-rehabilitation
Conditions
Brief summary
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.
Interventions
OTHERtriple 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.
OTHERtriple 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.
Sponsors
China International Medical Foundation
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Critical weight loss | About 6 weeks | Weight loss over 5% during radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0 | About 6 weeks | Adverse reactions of radiotherapy |
| Intake assessed by a simple diet self-assessment tool (SDSAT) | About 6 weeks | Intake assessed by a simple diet self-assessment tool (SDSAT) |
| Physical performance | About 6 weeks | Physical performance measured by the 4-Meter Walk Test |
| Body composition measured by Bioelectrical Impedance Analysis (BIA) | About 6 weeks | Body composition measured by Bioelectrical Impedance Analysis (BIA) |
| Quality of life of patients assessed by QLQ-C30 | About 6 weeks | Quality of life of patients assessed by QLQ-C30 |
| Number of participants with intervention-related adverse events | About 6 weeks | Number of participants with intervention-related adverse events |
| 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 compliance of the study |
| Patients in the intervention group were interviewed about the experience of the study | About 6 weeks | Patients in the intervention group were interviewed about the experience of the study |
| Psychological status assessed by hospital anxiety and depression scale (HADS) | About 6 weeks | Psychological status assessed by hospital anxiety and depression scale (HADS) |
Countries
China
Outcome results
None listed